CRO Industry News
Tuesday, 27 September 2011 10:56
clinicalRSVP Expands Phase 1 Network, Joins Two California Sites
clinicalRSVP, the nationwide network that prevents research volunteers from enrolling in multiple concurrent research studies, today announced the addition of Anaheim Clinical Trials and Profil Institute for Clinical Research, Inc. to the clinicalRSVP network.
Published in
CRO Industry News
Friday, 23 September 2011 07:42
PRA Experts To Speak At Drug Safety Conference
PRA, a leading Clinical Research Organization, announces that two experts from our Safety and Risk Management (SRM) group will present at the European World Drug Safety Congress being held in London from 13-16 September 2011. PRA will also host an exhibit at booth #2, where additional SRM representatives will be available to discuss PRA’s approach to pharmacovigilance.
Dr. Sabine Richter, PRA’s Vice President of SRM, will chair the “Risk Management” breakout stream on day one of the event. At 1:00PM BST, Dr. Richter will deliver opening remarks for the session, which will cover risk management plans, safety reporting, and risk-benefit balance during research and development.
Dr. Hemendra Misra, Director of Risk Management at PRA, will give a presentation titled, “Development Safety Update Reports (DSURs): The Time is Now” at 2:25PM BST. Dr. Misra's speech will summarize new legal requirements and explain how a DSUR can be used as an effective tool for risk identification and assessment.
Dr. Richter has over 20 years of research experience in the pharmaceutical and clinical research industries as well as in academia. Since joining PRA’s SRM team in 2004, she has delivered numerous projects for a variety of clients and led large, long-term safety programs involving as many as 50 countries on five continents. As the head of PRA’s SRM group, Dr. Richter has developed robust procedures and quality control measures to ensure consistent high performance and regulatory compliance.
A pharmacovigilance physician with 15 years of international work experience, Dr. Misra’s background includes positions at hospitals in India and with Médecins Sans Frontières (Doctors Without Borders), as well as seven years of industry experience with both pharmaceutical and clinical research organizations. Dr. Misra has also served as a medical monitor and conducted safety surveillance of marketed drugs as well as drugs in development.
PRA’s SRM group provides services throughout the entire product life cycle. The team includes over 100 experts available to clients for consultancy as well as routine and specialty pharmacovigilance services. Most of these staff members are healthcare professionals (nurses, pharmacists, physicians) or life scientists. PRA’s drug safety centers are based in our Mannheim, Germany; Swansea, UK; Charlottesville, VA (US); and Sao Paulo, Brazil offices.
About PRA
PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.
We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.
To learn more about PRA, please visit praintl.com, email This email address is being protected from spambots. You need JavaScript enabled to view it. or call our Global Headquarters.
Dr. Sabine Richter, PRA’s Vice President of SRM, will chair the “Risk Management” breakout stream on day one of the event. At 1:00PM BST, Dr. Richter will deliver opening remarks for the session, which will cover risk management plans, safety reporting, and risk-benefit balance during research and development.
Dr. Hemendra Misra, Director of Risk Management at PRA, will give a presentation titled, “Development Safety Update Reports (DSURs): The Time is Now” at 2:25PM BST. Dr. Misra's speech will summarize new legal requirements and explain how a DSUR can be used as an effective tool for risk identification and assessment.
Dr. Richter has over 20 years of research experience in the pharmaceutical and clinical research industries as well as in academia. Since joining PRA’s SRM team in 2004, she has delivered numerous projects for a variety of clients and led large, long-term safety programs involving as many as 50 countries on five continents. As the head of PRA’s SRM group, Dr. Richter has developed robust procedures and quality control measures to ensure consistent high performance and regulatory compliance.
A pharmacovigilance physician with 15 years of international work experience, Dr. Misra’s background includes positions at hospitals in India and with Médecins Sans Frontières (Doctors Without Borders), as well as seven years of industry experience with both pharmaceutical and clinical research organizations. Dr. Misra has also served as a medical monitor and conducted safety surveillance of marketed drugs as well as drugs in development.
PRA’s SRM group provides services throughout the entire product life cycle. The team includes over 100 experts available to clients for consultancy as well as routine and specialty pharmacovigilance services. Most of these staff members are healthcare professionals (nurses, pharmacists, physicians) or life scientists. PRA’s drug safety centers are based in our Mannheim, Germany; Swansea, UK; Charlottesville, VA (US); and Sao Paulo, Brazil offices.
About PRA
PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.
We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.
To learn more about PRA, please visit praintl.com, email This email address is being protected from spambots. You need JavaScript enabled to view it. or call our Global Headquarters.
Published in
CRO Industry News
Friday, 23 September 2011 07:23
Greenphire Closes Series A Financing Led By FirstMark Capital
Greenphire, the leading provider of web-based payment and communication technologies for the healthcare clinical trials industry, announced today that it has completed a Series A financing led by prominent New York-based venture capital firm, FirstMark Capital.
All of Greenphire’s existing angel investors, including leading healthcare industry veterans and entrepreneurs, participated in the funding. Gerald A. Poch, a Founder and Managing Director at FirstMark Capital, will join Greenphire’s Board of Directors alongside the company’s existing Directors—CEO Samuel Whitaker, Dr. Neil Rotherham, and David Reuter—as part of the financing. The Series A funding will support the recent launch of Greenphire’s innovative eClinicalGPS technology, a clinical payment platform designed to automate site and vendor payments within the clinical research environment. Additionally, the capital will be used to expand global sales and marketing initiatives for Greenphire’s flagship technology platform, the ClinCard System, which currently hosts a client base of more than 140 clinical trials sponsors, research sites, contract research organizations and research universities.
Gerald A. Poch stated, “Greenphire’s strong management team, established track record with existing, top-tier clients, and the accelerated adoption of the company’s new eClinicalGPS technology were critical to our investment decision. FirstMark is excited to have the opportunity to build upon the existing success achieved by the Greenphire team. This investment represents a unique opportunity to take advantage of internet and payment-processing technologies to provide the healthcare industry with a real-time, secure, and regulatory-compliant payment and communications network.”
Dr. Neil Rotherham, co-founder of ClinPhone and the Executive Director of Greenphire’s board since 2009, also offered his perspective on the deal, stating, “We are delighted to have Jerry Poch and his FirstMark team on board. Greenphire is a very exciting business with a tremendous future and it is good to see this endorsed by such an experienced investor. We will be looking to drive the business forward in the coming months with further development of our products and the strengthening of our commercial and project management teams.”
Greenphire co-founder and CEO Samuel Whitaker expressed his enthusiasm with the infusion of growth capital, commenting, "Our company has recognized phenomenal growth in an industry that is notorious for slow adoption of new technology. Our clients continue to rave about our technology platforms and the corresponding support that is provided throughout each study. Our partnership with FirstMark and the growth capital that has been provided by all of our investors will give us the fuel to expand our team and continue to improve operations, support and product functionality.”
About Greenphire’s ClinCard System:
Greenphire’s ClinCard System is a web-based platform enabling pharmaceutical sponsors, CROs, research universities, and clinical research sites to manage global subject payments, and use text, email, and voice messaging programs to communicate with subjects throughout the clinical trials experience. The ClinCard System is currently supporting over 8,000 studies and 60,000 patients across 1,500 clinical research sites in North America and Europe.
About Greenphire’s eClinicalGPS Technology:
The eClinicalGPS technology allows pharmaceutical sponsors to manage and automate all investigator, site, and vendor payments associated with a clinical study from a single web-based portal, replacing traditional manual payment processes and drastically reducing administrative burden.
About Greenphire:
Greenphire’s clinical payment and communication solutions take a patient-centric and site-centric approach to driving data integrity and data completeness for sponsors, CROs, research universities, and clinical research sites. Greenphire’s web-based technologies are designed to improve the clinical experience for patients and sites, drive positive patient behavior, increase patient retention and compliance, significantly reduce site and study team administration associated with payment management, and manage regulatory risk associated with both patient payments and the Sunshine Act. Learn more about Greenphire’s innovative clinical solutions at www.greenphire.com.
About FirstMark Capital:
Based in New York City, FirstMark Capital invests in ground-breaking companies that are creating new markets with innovative technology solutions or fundamentally changing existing markets by applying a fresh approach and new business model. A venture leader with more than $2 billion in capital commitments, FirstMark's team of investment and operations professionals have decades of real-world experience and leadership in core technology markets, making the firm uniquely qualified to offer industry insight, relationships and the operational expertise to build lasting businesses. Select historical investments include: Riot Games (Acquired by Tencent Holdings); Duck Creek Technologies (Acquired by Accenture); Netgear (NASDAQ: NTGR); Boomi (Acquired by Dell); First Advantage (Acquired by First American Corporation); StubHub (Acquired by eBay); Netegrity (Acquired by CA); Flarion (Acquired by Qualcomm); OutlookSoft (Acquired by SAP); Vallent (Acquired by IBM); and Navic Networks (Acquired by Microsoft). Current investments include: SecondMarket, Knewton, Pinterest, Lumos Labs, OpenGamma, Shopify and HealthPlanOne. For more information, please visit: www.firstmarkcap.com.
All of Greenphire’s existing angel investors, including leading healthcare industry veterans and entrepreneurs, participated in the funding. Gerald A. Poch, a Founder and Managing Director at FirstMark Capital, will join Greenphire’s Board of Directors alongside the company’s existing Directors—CEO Samuel Whitaker, Dr. Neil Rotherham, and David Reuter—as part of the financing. The Series A funding will support the recent launch of Greenphire’s innovative eClinicalGPS technology, a clinical payment platform designed to automate site and vendor payments within the clinical research environment. Additionally, the capital will be used to expand global sales and marketing initiatives for Greenphire’s flagship technology platform, the ClinCard System, which currently hosts a client base of more than 140 clinical trials sponsors, research sites, contract research organizations and research universities.
Gerald A. Poch stated, “Greenphire’s strong management team, established track record with existing, top-tier clients, and the accelerated adoption of the company’s new eClinicalGPS technology were critical to our investment decision. FirstMark is excited to have the opportunity to build upon the existing success achieved by the Greenphire team. This investment represents a unique opportunity to take advantage of internet and payment-processing technologies to provide the healthcare industry with a real-time, secure, and regulatory-compliant payment and communications network.”
Dr. Neil Rotherham, co-founder of ClinPhone and the Executive Director of Greenphire’s board since 2009, also offered his perspective on the deal, stating, “We are delighted to have Jerry Poch and his FirstMark team on board. Greenphire is a very exciting business with a tremendous future and it is good to see this endorsed by such an experienced investor. We will be looking to drive the business forward in the coming months with further development of our products and the strengthening of our commercial and project management teams.”
Greenphire co-founder and CEO Samuel Whitaker expressed his enthusiasm with the infusion of growth capital, commenting, "Our company has recognized phenomenal growth in an industry that is notorious for slow adoption of new technology. Our clients continue to rave about our technology platforms and the corresponding support that is provided throughout each study. Our partnership with FirstMark and the growth capital that has been provided by all of our investors will give us the fuel to expand our team and continue to improve operations, support and product functionality.”
About Greenphire’s ClinCard System:
Greenphire’s ClinCard System is a web-based platform enabling pharmaceutical sponsors, CROs, research universities, and clinical research sites to manage global subject payments, and use text, email, and voice messaging programs to communicate with subjects throughout the clinical trials experience. The ClinCard System is currently supporting over 8,000 studies and 60,000 patients across 1,500 clinical research sites in North America and Europe.
About Greenphire’s eClinicalGPS Technology:
The eClinicalGPS technology allows pharmaceutical sponsors to manage and automate all investigator, site, and vendor payments associated with a clinical study from a single web-based portal, replacing traditional manual payment processes and drastically reducing administrative burden.
About Greenphire:
Greenphire’s clinical payment and communication solutions take a patient-centric and site-centric approach to driving data integrity and data completeness for sponsors, CROs, research universities, and clinical research sites. Greenphire’s web-based technologies are designed to improve the clinical experience for patients and sites, drive positive patient behavior, increase patient retention and compliance, significantly reduce site and study team administration associated with payment management, and manage regulatory risk associated with both patient payments and the Sunshine Act. Learn more about Greenphire’s innovative clinical solutions at www.greenphire.com.
About FirstMark Capital:
Based in New York City, FirstMark Capital invests in ground-breaking companies that are creating new markets with innovative technology solutions or fundamentally changing existing markets by applying a fresh approach and new business model. A venture leader with more than $2 billion in capital commitments, FirstMark's team of investment and operations professionals have decades of real-world experience and leadership in core technology markets, making the firm uniquely qualified to offer industry insight, relationships and the operational expertise to build lasting businesses. Select historical investments include: Riot Games (Acquired by Tencent Holdings); Duck Creek Technologies (Acquired by Accenture); Netgear (NASDAQ: NTGR); Boomi (Acquired by Dell); First Advantage (Acquired by First American Corporation); StubHub (Acquired by eBay); Netegrity (Acquired by CA); Flarion (Acquired by Qualcomm); OutlookSoft (Acquired by SAP); Vallent (Acquired by IBM); and Navic Networks (Acquired by Microsoft). Current investments include: SecondMarket, Knewton, Pinterest, Lumos Labs, OpenGamma, Shopify and HealthPlanOne. For more information, please visit: www.firstmarkcap.com.
Published in
CRO Industry News
Friday, 23 September 2011 07:19
Ricerca Biosciences To Host “Current Challenges On The Critical Path To IND” Fall Symposia
Experts at Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, will host a symposia series this fall on the topic, “Current Challenges on the Critical Path to IND.”
The informative series will focus on regulatory and development strategies, approaches to de-risking targets during the discovery phase, evaluation cardiovascular toxicity and effective preparation for an IND filing. These sessions are scientifically focused and will address current topical issues relating to drug development and regulatory strategies.
“This series will provide our audience with the knowledge to plan a program, nominate a drug development candidate and advance the candidate into a Phase I clinical trial,” stated Ian Lennox, CEO of Ricerca.
Topics covered during the symposia series include:
Current Challenges on the Critical Path to IND symposia series will be presented on the following dates and locations:
The series will be held from 2-5:30 p.m., followed by a cocktail reception from 5:30-7 p.m. (local time). The series is free, but attendees must register to attend.
Ricerca Biosciences provides a full range of preclinical services from early discovery medicinal chemistry, compound screening, profiling and lead optimization through full drug safety, metabolism and efficacy development support, as well as clinical supply and commercial API production capability.
About Ricerca Biosciences
Ricerca Biosciences, offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. At Ricerca, our scientific excellence and reliable, cost-effective strategies help accelerate your drug discovery programs via our U.S.-based facilities in Concord, Ohio, and Bothell, Washington, and our ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon facility also holds AAALAC certification.
The informative series will focus on regulatory and development strategies, approaches to de-risking targets during the discovery phase, evaluation cardiovascular toxicity and effective preparation for an IND filing. These sessions are scientifically focused and will address current topical issues relating to drug development and regulatory strategies.
“This series will provide our audience with the knowledge to plan a program, nominate a drug development candidate and advance the candidate into a Phase I clinical trial,” stated Ian Lennox, CEO of Ricerca.
Topics covered during the symposia series include:
- Methods for Using In Vitro Pharmacological Data to Predict Downstream In Vivo Results
- Gaining Insight From In Vitro Assay Results Utilizing Ricerca’s Foresight Similarity Analysis Service
- Evaluating and Mitigating Genotoxic Impurities in Drug Substance
- Preclinical Approaches to Identifying and Managing Cardiovascular Safety Liabilities
Current Challenges on the Critical Path to IND symposia series will be presented on the following dates and locations:
- Tuesday, October 4: San Francisco, California, USA
- Monday, October 17: Conshohocken, Pennsylvania, USA
- Wednesday, October 19: Boston, Massachusetts, USA
- Tuesday, November 8: London, United Kingdom
- Wednesday, November 9: Paris, France
The series will be held from 2-5:30 p.m., followed by a cocktail reception from 5:30-7 p.m. (local time). The series is free, but attendees must register to attend.
Ricerca Biosciences provides a full range of preclinical services from early discovery medicinal chemistry, compound screening, profiling and lead optimization through full drug safety, metabolism and efficacy development support, as well as clinical supply and commercial API production capability.
About Ricerca Biosciences
Ricerca Biosciences, offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. At Ricerca, our scientific excellence and reliable, cost-effective strategies help accelerate your drug discovery programs via our U.S.-based facilities in Concord, Ohio, and Bothell, Washington, and our ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon facility also holds AAALAC certification.
Published in
CRO Industry News
Friday, 16 September 2011 06:11
BioClinica Announces Major New Release Of Express EDC Solution
BioClinica®, Inc., (NASDAQ: BIOC), a global provider of clinical trial management solutions, announced the latest release of BioClinica Express EDC. This modern, web-based platform is a comprehensive electronic data capture (EDC) solution that adds speed and quality to every part of the clinical trial process. Enhanced to utilize the latest web technologies, Express EDC makes it easier to monitor protocol compliance and close studies faster while meeting necessary regulations and guidelines. The newest Express application improves on the usability that sites already consider 'easiest' with flexible, scalable technology that coordinates and organizes the collection and dissemination of clean data.
Express joins BioClinica's other solutions to improve the efficiency and flexibility required for modern clinical trials. Express is fully integrated in real-time with BioClinica's Trident IWR and OnPoint CTMS systems. This enables real time data exchange between Express and OnPoint CTMS to support site payment data or visit status updates. Complementing best-in-class functionality is a web services architecture that communicates in real-time between applications and maximizes data visibility and utility viaSharePoint with built-in connectivity to Outlook and other Microsoft Office applications. Express also provides on-demand exports for further analysis in SAS or other analytical tools.
"This release of Express EDC is a major advancement for the BioClinica Suite. Sponsors and CROs can choose any of our world-class solutions as a stand-alone or a starting point - then augment functionality for any study when they need it," said Peter Benton, President of eClinical Solutions for BioClinica. "With the only portfolio of eClinical applications all created within the last five years, BioClinica offers a remarkably different approach with fresh ideas to address the challenges facing clinical organizations globally."
BioClinica Express provides new capabilities for EDC power users that make slicing and dicing incoming data fast and easy and automatically encodes medical terms within the same application. Role-specific dashboards focus attention where it's needed the most and data managers can tag or bookmark data to facilitate workflow, save customized data and query listings as 'private' or 'public' for later use. Study build timelines are minimized using an innovative design environment that reduces programming and maximizes re-usability.
Express delivers CDISC-compliant output at the end of the trial to save sponsors time and maximize exchange or integration with partners. Express can also incorporate external data such as labs, PK data, imaging metadata, and other instrumentation data with the clinical data during the trial. This process eliminates end-of-study reconciliation, provides cleaner data faster, and simplifies the submission process.
See BioClinica Express EDC at the 2011 SCDM (Society for Clinical Data Management) Annual Conference in Baltimore at booth #401.
Follow BioClinica on the Trial Blazers blog at http://info.bioclinica.com/blog, and on twitter at http://twitter.com/bioclinica.
Express joins BioClinica's other solutions to improve the efficiency and flexibility required for modern clinical trials. Express is fully integrated in real-time with BioClinica's Trident IWR and OnPoint CTMS systems. This enables real time data exchange between Express and OnPoint CTMS to support site payment data or visit status updates. Complementing best-in-class functionality is a web services architecture that communicates in real-time between applications and maximizes data visibility and utility viaSharePoint with built-in connectivity to Outlook and other Microsoft Office applications. Express also provides on-demand exports for further analysis in SAS or other analytical tools.
"This release of Express EDC is a major advancement for the BioClinica Suite. Sponsors and CROs can choose any of our world-class solutions as a stand-alone or a starting point - then augment functionality for any study when they need it," said Peter Benton, President of eClinical Solutions for BioClinica. "With the only portfolio of eClinical applications all created within the last five years, BioClinica offers a remarkably different approach with fresh ideas to address the challenges facing clinical organizations globally."
BioClinica Express provides new capabilities for EDC power users that make slicing and dicing incoming data fast and easy and automatically encodes medical terms within the same application. Role-specific dashboards focus attention where it's needed the most and data managers can tag or bookmark data to facilitate workflow, save customized data and query listings as 'private' or 'public' for later use. Study build timelines are minimized using an innovative design environment that reduces programming and maximizes re-usability.
Express delivers CDISC-compliant output at the end of the trial to save sponsors time and maximize exchange or integration with partners. Express can also incorporate external data such as labs, PK data, imaging metadata, and other instrumentation data with the clinical data during the trial. This process eliminates end-of-study reconciliation, provides cleaner data faster, and simplifies the submission process.
See BioClinica Express EDC at the 2011 SCDM (Society for Clinical Data Management) Annual Conference in Baltimore at booth #401.
Follow BioClinica on the Trial Blazers blog at http://info.bioclinica.com/blog, and on twitter at http://twitter.com/bioclinica.
Published in
CRO Industry News
Friday, 16 September 2011 06:06
PRA Named A Scrip Awards Finalist
PRA, a leading Clinical Research Organization, announces our selection as a finalist in the Best CRO category of the 2011 Scrip Awards. The winner will be announced at the Scrip Awards presentation being held at the Grosvenor House Hotel in London on 3 November 2011.
Selections for the shortlist were based on the CRO’s performance from June 2010 through July 2011. Judges evaluated each CRO’s ability to focus on innovations in patient recruitment strategy; demonstrate a wide range of capabilities and strengths; deliver results and exceed client expectations; improve performance; and streamline data collection and reporting.
“This recognition is a testament to the innovative and effective work that PRA has been doing for our customers,” said Tami Klerr-Naivar, PRA’s Senior Vice President of Business Development. “We are proud to be considered for this significant award, which provides the opportunity to demonstrate our continued growth and excellence in the clinical research market.”
With over 4100 employees, PRA offers a wide range of services across Phases I-IV. In addition to a full suite of product registration services, our Early Development Services unit conducts Phase I – IIa studies through our United States and European clinics and our Late Phase Services group specializes in Phase IIIb – IV and registry studies.
About PRA
PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.
We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.
To learn more about PRA, please visit praintl.com, email This email address is being protected from spambots. You need JavaScript enabled to view it. or call our Global Headquarters.
Selections for the shortlist were based on the CRO’s performance from June 2010 through July 2011. Judges evaluated each CRO’s ability to focus on innovations in patient recruitment strategy; demonstrate a wide range of capabilities and strengths; deliver results and exceed client expectations; improve performance; and streamline data collection and reporting.
“This recognition is a testament to the innovative and effective work that PRA has been doing for our customers,” said Tami Klerr-Naivar, PRA’s Senior Vice President of Business Development. “We are proud to be considered for this significant award, which provides the opportunity to demonstrate our continued growth and excellence in the clinical research market.”
With over 4100 employees, PRA offers a wide range of services across Phases I-IV. In addition to a full suite of product registration services, our Early Development Services unit conducts Phase I – IIa studies through our United States and European clinics and our Late Phase Services group specializes in Phase IIIb – IV and registry studies.
About PRA
PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.
We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.
To learn more about PRA, please visit praintl.com, email This email address is being protected from spambots. You need JavaScript enabled to view it. or call our Global Headquarters.
Published in
CRO Industry News
Thursday, 15 September 2011 12:14
CRF Health Appoints John Harrison, PhD As Scientific Consultant
CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry, announced that John Harrison, PhD, had accepted an appointment as Scientific Consultant. in this role, John will provide expert advice on both patient and clinician reported outcomes in Central Nervous System (CNS) related clinical studies.
John has over 15 years of extensive experience in selection and integration of cognitive testing into drug development programs. Most recently he was Principal Scientist at CogState Ltd, a company providing cognitive testing services to pharmaceutical companies. He is also Honorary Senior Lecturer at Imperial College in London where, among other topics, he invested cognitive change as a function of disease progression in Alzheimer's disease and HIV infection. Prior to his position with CogState, John was an independent consultant to drug development companies thought CPC Pharma Services, a consultancy that services pharmaceutical and biotechnology companies.
John's education includes a BSc in Psychology from the University of Hertfordshire and a PhD in Neuroscience from the University of London. He is currently studying for a BA in Classical Studies from the Open University. He resides in the West of England with his wife Rachel and two children. In addition to his interest on the measurement of cognitive change, he enjoys ballet, opera, and studying classical civilization.
Rachael King, CEO, commented, "we are very please to have recruited Dr. Harrison in a consulting role. The world-wide aging population has triggered growing interest in Dementia and other age-related diseases. John's breadth and depth of knowledge in this area will help CRF Health develop industry-leading services for clinical trials these areas.
About CRF Health
CRF Health is a global leader in ePRO (electronic patient reported outcomes) solutions for the life sciences industry. Through innovative technology, a thorough understanding of drug development, and mobile computing, CRF Health is driving the change to higher quality outcomes and more efficient paper-free clinical trials.
CRF Health's ePRO technology has been used in more than 70 countries, on six continents and 68 regional languages, including several regional Indian dialects. CRF Health consistently demonstrates the industry's highest patient compliance rates, while delivering unrivaled data accuracy and unmatched patient and site acceptance.
Since its founding in 2000, CRF Health continues to provide true global ePRO delivery and service. Headquartered in the U.S., CRF Health operates its R&D center of excellence in Helsinki, Finland, and has offices around the world.
For more information, please visit www.crfhealth.com
John has over 15 years of extensive experience in selection and integration of cognitive testing into drug development programs. Most recently he was Principal Scientist at CogState Ltd, a company providing cognitive testing services to pharmaceutical companies. He is also Honorary Senior Lecturer at Imperial College in London where, among other topics, he invested cognitive change as a function of disease progression in Alzheimer's disease and HIV infection. Prior to his position with CogState, John was an independent consultant to drug development companies thought CPC Pharma Services, a consultancy that services pharmaceutical and biotechnology companies.
John's education includes a BSc in Psychology from the University of Hertfordshire and a PhD in Neuroscience from the University of London. He is currently studying for a BA in Classical Studies from the Open University. He resides in the West of England with his wife Rachel and two children. In addition to his interest on the measurement of cognitive change, he enjoys ballet, opera, and studying classical civilization.
Rachael King, CEO, commented, "we are very please to have recruited Dr. Harrison in a consulting role. The world-wide aging population has triggered growing interest in Dementia and other age-related diseases. John's breadth and depth of knowledge in this area will help CRF Health develop industry-leading services for clinical trials these areas.
About CRF Health
CRF Health is a global leader in ePRO (electronic patient reported outcomes) solutions for the life sciences industry. Through innovative technology, a thorough understanding of drug development, and mobile computing, CRF Health is driving the change to higher quality outcomes and more efficient paper-free clinical trials.
CRF Health's ePRO technology has been used in more than 70 countries, on six continents and 68 regional languages, including several regional Indian dialects. CRF Health consistently demonstrates the industry's highest patient compliance rates, while delivering unrivaled data accuracy and unmatched patient and site acceptance.
Since its founding in 2000, CRF Health continues to provide true global ePRO delivery and service. Headquartered in the U.S., CRF Health operates its R&D center of excellence in Helsinki, Finland, and has offices around the world.
For more information, please visit www.crfhealth.com
Published in
CRO Industry News
Thursday, 15 September 2011 11:52
DaVita Clinical Research Central Laboratory Expands Its Services And Technology
DaVita Clinical Research® (DCR®), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, has announced the company’s expansion within its Central Laboratory.
DCR’s Central Laboratory is focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas, as well as chronic kidney disease (CKD) populations. By year’s end, the lab’s test menu will increase by 43 percent, maintaining the company’s leadership position in advanced renal care while ensuring critical coverage in the areas of oncology, immunology, endocrinology, cardiology and anemia.
The testing facility has expanded its technology through the addition of two new testing platforms, the IMMULITE 2000 XPi Immunoassay System and the AB SCIEX QTRAP 5500 LC/MS/MS system. Other additions include increased specimen management and storage capabilities for both short- and long-term testing. The Central Laboratory facilitates satisfaction with continuous IT advancements, allowing for clean, timely data and ease of customer access to laboratory results. DCR’s commitment to “Excellence Through Innovation” is evident by its continual, selective additions of scientific and operational staff coming from the CRO and pharma communities.
In addition, DCR recently announced the launch of its Biorepository Services. The biorepository contains collections of biological material and their pertinent databases that are systemized for the purpose of research. This new, one-of-a-kind, state-of-the-art biorepository dramatically improves the odds of a breakthrough discovery by combining samples meticulously collected from our nationwide network of over 1,700 sites richly annotated with patient-level heath information.
“We are proud of our recent investments in equipment and assay development,” stated DCR Vice President of Commercial Development Kevin J. Goudreau. “These investments will allow us to supply central laboratory services outside of renal care. We will continue to invest heavily in assay development until the breadth of our offering covers virtually all therapeutic indications.”
DaVita and DCR are trademarks or registered trademarks of DaVita Inc. All other trademarks are the property of their respective owners.
About DaVita Clinical Research (DCR)
DaVita Clinical Research (DCR) is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, ensuring the success of their clients’ clinical trials. DCR’s clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites, Health Economics and Central Laboratory are focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit www.davitaclinicalresearch.com.
About DaVita
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services to patients with chronic kidney failure and end stage renal disease. DaVita strives to improve patients’ quality of life by innovating clinical care, and by offering integrated treatment plans, personalized care teams and convenient health-management services. As of June 30, 2011, DaVita operated or provided administrative services at 1,669 dialysis facilities, serving approximately 131,000 patients. DaVita supports numerous programs dedicated to creating positive, sustainable change in communities around the world. The company’s leadership development initiatives and social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu. For more information, please visit www.davita.com.
DCR’s Central Laboratory is focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas, as well as chronic kidney disease (CKD) populations. By year’s end, the lab’s test menu will increase by 43 percent, maintaining the company’s leadership position in advanced renal care while ensuring critical coverage in the areas of oncology, immunology, endocrinology, cardiology and anemia.
The testing facility has expanded its technology through the addition of two new testing platforms, the IMMULITE 2000 XPi Immunoassay System and the AB SCIEX QTRAP 5500 LC/MS/MS system. Other additions include increased specimen management and storage capabilities for both short- and long-term testing. The Central Laboratory facilitates satisfaction with continuous IT advancements, allowing for clean, timely data and ease of customer access to laboratory results. DCR’s commitment to “Excellence Through Innovation” is evident by its continual, selective additions of scientific and operational staff coming from the CRO and pharma communities.
In addition, DCR recently announced the launch of its Biorepository Services. The biorepository contains collections of biological material and their pertinent databases that are systemized for the purpose of research. This new, one-of-a-kind, state-of-the-art biorepository dramatically improves the odds of a breakthrough discovery by combining samples meticulously collected from our nationwide network of over 1,700 sites richly annotated with patient-level heath information.
“We are proud of our recent investments in equipment and assay development,” stated DCR Vice President of Commercial Development Kevin J. Goudreau. “These investments will allow us to supply central laboratory services outside of renal care. We will continue to invest heavily in assay development until the breadth of our offering covers virtually all therapeutic indications.”
DaVita and DCR are trademarks or registered trademarks of DaVita Inc. All other trademarks are the property of their respective owners.
About DaVita Clinical Research (DCR)
DaVita Clinical Research (DCR) is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, ensuring the success of their clients’ clinical trials. DCR’s clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites, Health Economics and Central Laboratory are focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit www.davitaclinicalresearch.com.
About DaVita
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services to patients with chronic kidney failure and end stage renal disease. DaVita strives to improve patients’ quality of life by innovating clinical care, and by offering integrated treatment plans, personalized care teams and convenient health-management services. As of June 30, 2011, DaVita operated or provided administrative services at 1,669 dialysis facilities, serving approximately 131,000 patients. DaVita supports numerous programs dedicated to creating positive, sustainable change in communities around the world. The company’s leadership development initiatives and social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu. For more information, please visit www.davita.com.
Published in
CRO Industry News
Thursday, 15 September 2011 11:49
MedNet Solutions Launches iMedNet CRO Partner Program
MedNet Solutions, a global life sciences technology solutions company specializing in clinical study management systems, is pleased to announce the official launch of it iMedNet CRO Partner Program. Designed specifically to help Clinical Research Organizations (CROs) improve research efficiency, expand their service offerings, decrease internal costs and win more business, the program provides CROs with compelling marketplace advantages.
At the core of the program is iMedNet EDC, MedNet's recently released cloud-based, software-as-a-service (SaaS) eClinical solution that allows non-technical clinical research personnel to quickly and easily setup and maintain their own EDC studies. iMedNet EDC's intuitive study configuration tools and form libraries allow studies to be set up in days, not weeks or months. Even entire studies can be replicated in a matter of seconds.
Key additional program features include:
Affordable pricing - iMedNet's CRO Partner pricing model eliminates up front fees and dramatically lowers overall costs making iMedNet EDC practical for all research initiatives - even pre-clinical and phase 1 studies.
Comprehensive iMedNet Designer Training - MedNet provides a complete iMedNet EDC training and certification program ensuring that all CRO personnel involved in the design and configuration of iMedNet studies are fully versed in the capabilities of the system.
Full Sales and Marketing Support - MedNet directly supports the sales efforts of iMedNet CRO Partners with a complete range of services, from marketing materials and demonstration support, to prospective customer referrals and joint promotional activities.
For more information about MedNet Solutions, iMedNet EDC, or the iMedNet CRO Partner Program, please call MedNet Solutions at (866) 258-2735, email MedNet at This email address is being protected from spambots. You need JavaScript enabled to view it. , or visit www.mednetstudy.com.
About MedNet Solutions
MedNet Solutions is a leading healthcare technology company specializing in electronic data capture (EDC) and clinical study management systems designed for the global life sciences market. Applying critical insight, proven technology and unwavering support, MedNet delivers powerful, flexible and easy‐to‐use web‐based eClinical solutions that effectively support clinical studies, registries and investigator initiated trials. Since 2000, MedNet has successfully supported leading pharmaceutical, medical device, biotechnology, and contract research organizations on clinical research conducted around the world. MedNet delivers a superior customer experience from beginning to end. For more information, please visit www.mednetstudy.com.
At the core of the program is iMedNet EDC, MedNet's recently released cloud-based, software-as-a-service (SaaS) eClinical solution that allows non-technical clinical research personnel to quickly and easily setup and maintain their own EDC studies. iMedNet EDC's intuitive study configuration tools and form libraries allow studies to be set up in days, not weeks or months. Even entire studies can be replicated in a matter of seconds.
Key additional program features include:
Affordable pricing - iMedNet's CRO Partner pricing model eliminates up front fees and dramatically lowers overall costs making iMedNet EDC practical for all research initiatives - even pre-clinical and phase 1 studies.
Comprehensive iMedNet Designer Training - MedNet provides a complete iMedNet EDC training and certification program ensuring that all CRO personnel involved in the design and configuration of iMedNet studies are fully versed in the capabilities of the system.
Full Sales and Marketing Support - MedNet directly supports the sales efforts of iMedNet CRO Partners with a complete range of services, from marketing materials and demonstration support, to prospective customer referrals and joint promotional activities.
For more information about MedNet Solutions, iMedNet EDC, or the iMedNet CRO Partner Program, please call MedNet Solutions at (866) 258-2735, email MedNet at This email address is being protected from spambots. You need JavaScript enabled to view it. , or visit www.mednetstudy.com.
About MedNet Solutions
MedNet Solutions is a leading healthcare technology company specializing in electronic data capture (EDC) and clinical study management systems designed for the global life sciences market. Applying critical insight, proven technology and unwavering support, MedNet delivers powerful, flexible and easy‐to‐use web‐based eClinical solutions that effectively support clinical studies, registries and investigator initiated trials. Since 2000, MedNet has successfully supported leading pharmaceutical, medical device, biotechnology, and contract research organizations on clinical research conducted around the world. MedNet delivers a superior customer experience from beginning to end. For more information, please visit www.mednetstudy.com.
Published in
CRO Industry News
Wednesday, 07 September 2011 09:59
Xcelience Expands Clinical Trial Supplies Manufacturing And Packaging
Xcelience, a leader in early drug development, has expanded clinical trial supplies manufacturing and packaging capabilities to include four new pieces of equipment and a new fully-automated packaging line.
To complement existing expertise in matrix tablet delivery systems, Xcelience added a MG Futura (capsule-filling machine for powder and pellets), LCI Multi-granulator MG-55 (extruder), QJ-230T marumerizer (spheronizer), and wurster insert (bottom spray) to the existing Glatt GPCG-3 fluid bed processor. These new pieces enable production, coating and encapsulation of MUDF delivery
systems.
“The new MG Futura is a great example of our continued commitment to add state-of-the-art technology that delivers real value to our clients,” says Theodore Koontz, Director of Operations. “The MG Futura improves upon production times, increases overall capacity, and expands upon our existing capabilities for powders, pellets and powder micro-dosing for inhalation systems”.
In addition, Xcelience has added a fully-automated packaging line (including ink-jet coding) for primary bottling of tablets and capsules. The new packaging line enhances the speed at which batches are packaged, shortens timelines, and enhances our ability to package larger batches of drug product.
About Xcelience LLC
Xcelience is a contract research organization providing formulation development, drug preformulation, analytical, and clinical supplies manufacturing to a global client base since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Xcelience's unique corporate
structure creates project teams that work intensively with each client, bringing an extension of their own organization into the Xcelience lab. For more detailed information about Xcelience, visit www.xcelience.com.
To complement existing expertise in matrix tablet delivery systems, Xcelience added a MG Futura (capsule-filling machine for powder and pellets), LCI Multi-granulator MG-55 (extruder), QJ-230T marumerizer (spheronizer), and wurster insert (bottom spray) to the existing Glatt GPCG-3 fluid bed processor. These new pieces enable production, coating and encapsulation of MUDF delivery
systems.
“The new MG Futura is a great example of our continued commitment to add state-of-the-art technology that delivers real value to our clients,” says Theodore Koontz, Director of Operations. “The MG Futura improves upon production times, increases overall capacity, and expands upon our existing capabilities for powders, pellets and powder micro-dosing for inhalation systems”.
In addition, Xcelience has added a fully-automated packaging line (including ink-jet coding) for primary bottling of tablets and capsules. The new packaging line enhances the speed at which batches are packaged, shortens timelines, and enhances our ability to package larger batches of drug product.
About Xcelience LLC
Xcelience is a contract research organization providing formulation development, drug preformulation, analytical, and clinical supplies manufacturing to a global client base since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Xcelience's unique corporate
structure creates project teams that work intensively with each client, bringing an extension of their own organization into the Xcelience lab. For more detailed information about Xcelience, visit www.xcelience.com.
Published in
CRO Industry News
Want more? Visit...
Videos
-
ICON- Partnerships 12
Read more...
Steven Cutler, Group President of ICON discusses the launch of ICON's new acquisition of Firecrest at Partnerships in Clinical Trials 2012. Facing the continuing challenge of not only monitoring and… -
ICON- Partnerships 12
Read more...
Steven Cutler, Group President of ICON discusses their exciting new partnership with Roche at Partnerships In Clinical Trials 2012. Medical imaging has always been a strong department within ICON. ICON… -
ERT- Partnerships 12
Read more...
John Blakely, Executive Vice President and Chief Commercial Officer for ERT discusses the new trend in clinical research at Partnerships in Clinical Trials 2012 - the melding of objective and… -
Chiltern- Partnerships 12
Read more...
Marcelo Piccirillo, Senior Clinical Research Physician for Chiltern, discusses new trends in gastrointestinal clinical development at Partnerships in Clinical Trials 2012. Current hot spots for clinical development in the field… -
Blinded Diagnostics - Partnerships 12
Read more...
Paul Savuto, President and CFO, and Steven Karrupan, CEO, from Blinded Diagnostics discuss Point of Care Technology at Partnerships in Clinical Trials 2012. Point of care (or decentralized testing) offers… -
American Airlines - IQPC 2011
Read more...
American Airlines has globally launched a passive solutions that gives a new alternative to pharmaceutical manufacturers.
Podcasts
-
Three Tracks This Genentech Executive Won't Miss At DIA 2013
Life Science Leader magazine chief editor, Rob Wright, interviews Sandy Milligan, J.D., M.D., VP of regulatory affair for immunology, infectious…
-
What Does Diversity Mean in the 21st Century?
Bio International Conference Draws Co-Located Diversity, Inclusion & Life Sciences Symposium? BIOtechNow’s Tracy Cooley, interviews Rob Wright, chief editor of…
-
A Primer On What To Expect At DIA 2012
Insights from Martin Harvey-Allchurch of The European Medicines Agency Martin Harvey-Allchurch, head of communications at the European Medicines Agency (EMA)… -
Will Outsourcing Continue As Long-Term Strategy For The Pharma Industry?
Tips From PriceWaterhouseCoopers’ Jan Paul Zonnenberg Jan Paul Zonnenberg, partner, healthcare practice, PriceWaterhouseCoppers (PwC) provides insights into current trends with… -
PDA Report Changes Cold Chain Shipping - Cryoport Podcast Series
Larry Stambaugh, president and CEO of Cryoport – a life sciences global frozen logistics provider discusses with Life Science Leader… -
Overcoming Natural Disasters To Insure Sample Integrity - Cryoport Podcast Series
Rob Wright, Chief Editor of Life Science Leader Magazine, interviews Larry Stambaugh, President and CEO of Cryoport, a life sciences… -
Regulating The Cold Chain Involves More Agencies Than You Think - Cryoport Podcast Series
Rob Wright, Chief Editor of Life Science Leader Magazine, interviews Larry Stambaugh, President and CEO of Cryoport, a life sciences…