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Tuesday, 05 July 2011 06:23
Celerion appoints Dr. Raymond Farmen as Vice President of Global Bioanalytical Services
Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce the appointment of Dr. Raymond Farmen as Vice President of Global Bioanalytical Services. Dr. Farmen will have responsibility for the company’s bioanalytical operations in Zurich, Switzerland and Lincoln, Nebraska USA.
Dr. Farmen comes to Celerion with over 30 years of experience in the contract research organization (CRO) and pharmaceutical industries. Prior to joining Celerion, he held executive positions at PharmOptima, a CRO that specializes in ocular research services; Eurofins AvTech Laboratories, a CRO that specializes in small and large molecule bioanalytical chemistry as well as QC testing and analysis of finished drug products and pharmaceutical ingredients; and Camargo Pharmaceutical Services, a CRO that provides scientific and regulatory oversight during the drug development process. Dr. Farmen also held leadership positions in the bioanalytical sciences at MDS Pharma Services, Phoenix International Life Sciences, and Bristol-Myers Squibb.
Dr. Farmen has in-depth knowledge of both large and small molecule bioanalysis, DMPK, regulatory strategies, and GLP/GMP regulations. He played a pivotal role at the Crystal City meetings which helped to shape the early regulatory landscape and guidelines for bioanalysis of pharmaceutical products.
“We are very pleased to have Ray on the management team at Celerion,” said Susan Thornton, President and CEO of Celerion. “His in-depth knowledge of drug development, bioanalysis and regulatory strategy from both the client and CRO perspective will be a great asset to our organization.”
Dr. Farmen earned his doctorate in pharmacology from Indiana University and did post-doctoral research in Biochemistry at the Upstate Medical Center in Syracuse, New York.
About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.
Dr. Farmen comes to Celerion with over 30 years of experience in the contract research organization (CRO) and pharmaceutical industries. Prior to joining Celerion, he held executive positions at PharmOptima, a CRO that specializes in ocular research services; Eurofins AvTech Laboratories, a CRO that specializes in small and large molecule bioanalytical chemistry as well as QC testing and analysis of finished drug products and pharmaceutical ingredients; and Camargo Pharmaceutical Services, a CRO that provides scientific and regulatory oversight during the drug development process. Dr. Farmen also held leadership positions in the bioanalytical sciences at MDS Pharma Services, Phoenix International Life Sciences, and Bristol-Myers Squibb.
Dr. Farmen has in-depth knowledge of both large and small molecule bioanalysis, DMPK, regulatory strategies, and GLP/GMP regulations. He played a pivotal role at the Crystal City meetings which helped to shape the early regulatory landscape and guidelines for bioanalysis of pharmaceutical products.
“We are very pleased to have Ray on the management team at Celerion,” said Susan Thornton, President and CEO of Celerion. “His in-depth knowledge of drug development, bioanalysis and regulatory strategy from both the client and CRO perspective will be a great asset to our organization.”
Dr. Farmen earned his doctorate in pharmacology from Indiana University and did post-doctoral research in Biochemistry at the Upstate Medical Center in Syracuse, New York.
About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.
Published in
CRO Industry News
Monday, 27 June 2011 09:41
Pfizer Selects Exco InTouch’s Novel eDiary To Initiate First Ever Patient-Centered Clinical Trial
Exco InTouch, the leading provider of patient communication solutions for the pharmaceutical and healthcare sectors, has announced that its novel eDiary technologies have been selected by Pfizer, the world’s leading pharmaceutical company, as part of the first ever Participatory Patient-Centered (PPC) clinical trial. The pilot study will utilize Exco InTouch’s leading eDiary technologies to enable patients to participate regardless of location, age or proximity to site. Focusing on new Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) Phase 4 for the treatment of overactive bladder, the study will mimic a previously completed trial in order to replicate the results and validate this novel approach.
In order to support the success of this patient-centered, field-based clinical research, Pfizer required a mobile technology platform offering an ease-of-use interface that provided accessibility particularly for older patients. With an estimated five billion cellphone users worldwide, cell phones make an ideal and accessible platform for patient engagement in clinical trials. As part of the revolutionary new approach piloted by the REMOTE study, patients will be empowered to participate remotely in the screening process through trials via the internet, participate in trials that due to location may not have previously been possible, actively manage their own trial and report results directly to a trial. As a result, researchers expect to save time and obtain more reliable, higher quality data through increased patient compliance and engagement, lower withdrawal rates and real-time data collection. The new approach will also eliminate the significant costs associated with the management and co-ordination of running multiple clinical sites.
Exco InTouch offers three validated ePRO solutions, spanning simple diaries to the most complex clinical assessments, all of which can be customized to meet the requirements of individual trials. These technologies have been developed with an intuitive design to provide easy navigation that enhances the user experience, while positively impacting on-going compliance from patients, regardless of their age and logistics. Where specific and targeted data collection is required, patients can complete diary questionnaires via a series of text messages sent to their own cellphone. If a response is not received by the patient within a certain timeframe, a text message reminder can be automatically sent in order to prompt a response. The ability to capture patient data in “real-time” means that investigator site staff can be alerted to abnormal patient data and react to ensure patient safety.
“The REMOTE virtual trial pilot brings great potential to transform how patients access and participate in clinical trials,” said Miguel Orri MD, Senior Director and Clinical Lead, Pfizer. “The project brings the potential to accelerate clinical research while improving quality, measures vital to the future of drug development.”
Tim Davis, CEO of Exco InTouch, comments: “Exco InTouch is delighted that its leading ePRO technology has been selected to support such a revolutionary new study. The intuitive, light-weight and accessible nature of the Exco InTouch eDiary technology meant it was the natural choice for Pfizer in its efforts to increase access to clinical trials for the broadest patient population.”
For further information on the Exco InTouch range of solutions, please call +44 1279 709 040 or +1 877 327 5777 or visit www.excointouch.com.
For further press information please contact: Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA Tel: +44 1477 539539 Fax: +44 1477 539540 e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
About Exco InTouch
Exco InTouch is the leading provider of interactive patient communication solutions using internet and cell phone technology. Using a combination of software and services, Exco InTouch offers BioPharma sponsors, CROs and patient recruitment agencies the opportunity to improve patient recruitment, retention and compliance using timely notifications, alerts and two-way messages.
Additionally, Exco collects electronic patient reported outcomes (ePRO) and diary data using standard cell phone technology which is both cost effective for sponsors and extremely easy and convenient for trial subjects. These solutions are currently being used by hundreds of thousands of patients in over 70 countries, delivered in the local language and are fully compliant with HIPAA regulations, FDA CFR 21 Part 11 and all electronic communication privacy directives.
In order to support the success of this patient-centered, field-based clinical research, Pfizer required a mobile technology platform offering an ease-of-use interface that provided accessibility particularly for older patients. With an estimated five billion cellphone users worldwide, cell phones make an ideal and accessible platform for patient engagement in clinical trials. As part of the revolutionary new approach piloted by the REMOTE study, patients will be empowered to participate remotely in the screening process through trials via the internet, participate in trials that due to location may not have previously been possible, actively manage their own trial and report results directly to a trial. As a result, researchers expect to save time and obtain more reliable, higher quality data through increased patient compliance and engagement, lower withdrawal rates and real-time data collection. The new approach will also eliminate the significant costs associated with the management and co-ordination of running multiple clinical sites.
Exco InTouch offers three validated ePRO solutions, spanning simple diaries to the most complex clinical assessments, all of which can be customized to meet the requirements of individual trials. These technologies have been developed with an intuitive design to provide easy navigation that enhances the user experience, while positively impacting on-going compliance from patients, regardless of their age and logistics. Where specific and targeted data collection is required, patients can complete diary questionnaires via a series of text messages sent to their own cellphone. If a response is not received by the patient within a certain timeframe, a text message reminder can be automatically sent in order to prompt a response. The ability to capture patient data in “real-time” means that investigator site staff can be alerted to abnormal patient data and react to ensure patient safety.
“The REMOTE virtual trial pilot brings great potential to transform how patients access and participate in clinical trials,” said Miguel Orri MD, Senior Director and Clinical Lead, Pfizer. “The project brings the potential to accelerate clinical research while improving quality, measures vital to the future of drug development.”
Tim Davis, CEO of Exco InTouch, comments: “Exco InTouch is delighted that its leading ePRO technology has been selected to support such a revolutionary new study. The intuitive, light-weight and accessible nature of the Exco InTouch eDiary technology meant it was the natural choice for Pfizer in its efforts to increase access to clinical trials for the broadest patient population.”
For further information on the Exco InTouch range of solutions, please call +44 1279 709 040 or +1 877 327 5777 or visit www.excointouch.com.
For further press information please contact: Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA Tel: +44 1477 539539 Fax: +44 1477 539540 e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
About Exco InTouch
Exco InTouch is the leading provider of interactive patient communication solutions using internet and cell phone technology. Using a combination of software and services, Exco InTouch offers BioPharma sponsors, CROs and patient recruitment agencies the opportunity to improve patient recruitment, retention and compliance using timely notifications, alerts and two-way messages.
Additionally, Exco collects electronic patient reported outcomes (ePRO) and diary data using standard cell phone technology which is both cost effective for sponsors and extremely easy and convenient for trial subjects. These solutions are currently being used by hundreds of thousands of patients in over 70 countries, delivered in the local language and are fully compliant with HIPAA regulations, FDA CFR 21 Part 11 and all electronic communication privacy directives.
Published in
CRO Industry News
Monday, 27 June 2011 09:39
ERT Appoints Robert Kleiman MD to Chief Medical Officer
ERT, a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations, announced today that Robert Kleiman, M.D. has been appointed to the role of Chief Medical Officer in addition to his current role as Vice President of Global Cardiology.
Dr. Kleiman graduated from Brown University Medical School with residency in Internal Medicine and completed Fellowships in Cardiology and Cardiac Electrophysiology at the University of Pennsylvania. Prior to joining ERT as a full time employee in April 2004, Dr. Kleiman had worked for ERT as an independent contractor through his cardiology and cardiac electrophysiology practice since 1994. Dr. Kleiman has managed ERT’s cardiology group, which has more than tripled in size since 2004, while maintaining ERT’s standards for high quality and consistency.
In addition to his current duties as Vice President of Global Cardiology, Dr. Kleiman will be responsible for assuming an increasing consulting and sales role. “Dr. Kleiman combines remarkable industry expertise with years of experience in the hospital practice environment. These factors, coupled with his in-depth knowledge of our business operations, make him a perfect candidate for the position,” commented Dr. Jeffrey Litwin, President and Chief Executive Officer of ERT. “I would like to thank Bob for his dedicated service over the past eight years and congratulate him on this well deserved promotion. All of our employees look forward to continuing to work with him as he expands his role at ERT”.
Commenting on his appointment Dr Kleiman noted “I have enjoyed my long association with ERT and very much look forward to working with our customers and staff in my new role of working more closely with sponsors to ensure the efficacy and safety of new drugs”.
For further information on ERT and its technology and services, please contact Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. Phone +44 1477 539539, Fax +44 1477 539540, Email This email address is being protected from spambots. You need JavaScript enabled to view it. .
About ERT
ERT (www.ert.com) is a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations. It is the market leader for centralized cardiac safety and respiratory efficacy services in drug development and also collects, analyzes and distributes electronic Patient Reported Outcomes (ePRO) in multiple modalities across all phases of clinical research.
Dr. Kleiman graduated from Brown University Medical School with residency in Internal Medicine and completed Fellowships in Cardiology and Cardiac Electrophysiology at the University of Pennsylvania. Prior to joining ERT as a full time employee in April 2004, Dr. Kleiman had worked for ERT as an independent contractor through his cardiology and cardiac electrophysiology practice since 1994. Dr. Kleiman has managed ERT’s cardiology group, which has more than tripled in size since 2004, while maintaining ERT’s standards for high quality and consistency.
In addition to his current duties as Vice President of Global Cardiology, Dr. Kleiman will be responsible for assuming an increasing consulting and sales role. “Dr. Kleiman combines remarkable industry expertise with years of experience in the hospital practice environment. These factors, coupled with his in-depth knowledge of our business operations, make him a perfect candidate for the position,” commented Dr. Jeffrey Litwin, President and Chief Executive Officer of ERT. “I would like to thank Bob for his dedicated service over the past eight years and congratulate him on this well deserved promotion. All of our employees look forward to continuing to work with him as he expands his role at ERT”.
Commenting on his appointment Dr Kleiman noted “I have enjoyed my long association with ERT and very much look forward to working with our customers and staff in my new role of working more closely with sponsors to ensure the efficacy and safety of new drugs”.
For further information on ERT and its technology and services, please contact Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. Phone +44 1477 539539, Fax +44 1477 539540, Email This email address is being protected from spambots. You need JavaScript enabled to view it. .
About ERT
ERT (www.ert.com) is a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations. It is the market leader for centralized cardiac safety and respiratory efficacy services in drug development and also collects, analyzes and distributes electronic Patient Reported Outcomes (ePRO) in multiple modalities across all phases of clinical research.
Published in
CRO Industry News
Monday, 27 June 2011 09:34
TransPerfect and Sentrx Partner to Offer Pharmacovigilance Safety Solution
TransPerfect and Sentrx have announced a collaboration involving TransPerfect’s Trial Interactive Portal Technology, which will streamline end-to-end global drug safety capabilities in both clinical and post-marketing event management. Trial Interactive, already widely used throughout the biopharmaceutical industry for electronic Trial Master Files, investigator portals, IRB, and central laboratory solutions, collaborated with Sentrx to develop a novel safety module that is fully validated to be 21 CFR Part 11 compliant.
The Trial Interactive Portal Solution will enable direct safety information collection on a global basis from investigative site personnel via multiple sources, including fax, email, direct-entry, or by telephonic means, into a secure data portal. The approach will speed safety data exchange between safety teams and reporters while enhancing sponsors’ ability to support multiple stakeholders globally. The portal is fully compatible with Sentrx’s industry leading drug safety solution, SaPh™ which provides turnkey Argus Safety instance management in a hassle-free, hosted deployment.
According to Michael O’Gorman, President and General Manager of Sentrx, “Web based portal solutions have been identified as a critical imperative for achieving new gains in adverse event management efficiency. Our collaboration with Trial Interactive has produced a fully compliant safety portal platform to enhance workflow efficiency. We believe this is a breakthrough approach our respective client base will find compelling under a wide variety of applications.”
Michael Smyth, General Manager of TransPerfect’s Life Sciences Solutions division commented, “Working with Sentrx continues with our vision of offering end-to-end technology and service solutions to all study stakeholders, particularly investigative site personnel who are critical in the process of getting products to market faster. The addition of the safety module in Trial Interactive, developed with Sentrx, provides the ability to truly offer global Pharmacovigilance support to pharmaceutical, biotechnology, and medical device companies as well as CROs."
The Trial Interactive Portal Solution will enable direct safety information collection on a global basis from investigative site personnel via multiple sources, including fax, email, direct-entry, or by telephonic means, into a secure data portal. The approach will speed safety data exchange between safety teams and reporters while enhancing sponsors’ ability to support multiple stakeholders globally. The portal is fully compatible with Sentrx’s industry leading drug safety solution, SaPh™ which provides turnkey Argus Safety instance management in a hassle-free, hosted deployment.
According to Michael O’Gorman, President and General Manager of Sentrx, “Web based portal solutions have been identified as a critical imperative for achieving new gains in adverse event management efficiency. Our collaboration with Trial Interactive has produced a fully compliant safety portal platform to enhance workflow efficiency. We believe this is a breakthrough approach our respective client base will find compelling under a wide variety of applications.”
Michael Smyth, General Manager of TransPerfect’s Life Sciences Solutions division commented, “Working with Sentrx continues with our vision of offering end-to-end technology and service solutions to all study stakeholders, particularly investigative site personnel who are critical in the process of getting products to market faster. The addition of the safety module in Trial Interactive, developed with Sentrx, provides the ability to truly offer global Pharmacovigilance support to pharmaceutical, biotechnology, and medical device companies as well as CROs."
Published in
CRO Industry News
Friday, 24 June 2011 09:23
Oracle Health Sciences Delivers Oracle® Argus Safety From The Cloud
Cloud Offering Provides Health Sciences Organizations with New Options for Accelerating Time to Value
Oracle Health Sciences today announced the availability of Oracle® Argus Safety On Demand, a cloud-based version of Oracle’s industry-leading integrated global adverse events management and regulatory reporting solution. Oracle Argus Safety On Demand provides an advanced and comprehensive adverse events management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management.
As a cloud application, Oracle Argus Safety On Demand enables health sciences organizations and their contract resource organization (CRO) partners to accelerate deployment, obtain on-demand scalability, reduce IT management resource requirements and gain a more predictable IT spending pattern.
Oracle Argus Safety On Demand is part of a comprehensive portfolio of Oracle Health Sciences Cloud Applications and is powered by the Oracle Health Sciences Cloud.
“Oracle Argus Safety On Demand enables health sciences organizations to accelerate deployment and time to value for the industry’s leading adverse event reporting and management software,” said Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences. “Oracle Argus Safety, as delivered via the Oracle Health Sciences Cloud, provides new levels of agility in deploying, managing and scaling the comprehensive solution – all backed by Oracle’s unmatched technical and industry expertise.”
Oracle Health Sciences today announced the availability of Oracle® Argus Safety On Demand, a cloud-based version of Oracle’s industry-leading integrated global adverse events management and regulatory reporting solution. Oracle Argus Safety On Demand provides an advanced and comprehensive adverse events management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management.
As a cloud application, Oracle Argus Safety On Demand enables health sciences organizations and their contract resource organization (CRO) partners to accelerate deployment, obtain on-demand scalability, reduce IT management resource requirements and gain a more predictable IT spending pattern.
Oracle Argus Safety On Demand is part of a comprehensive portfolio of Oracle Health Sciences Cloud Applications and is powered by the Oracle Health Sciences Cloud.
“Oracle Argus Safety On Demand enables health sciences organizations to accelerate deployment and time to value for the industry’s leading adverse event reporting and management software,” said Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences. “Oracle Argus Safety, as delivered via the Oracle Health Sciences Cloud, provides new levels of agility in deploying, managing and scaling the comprehensive solution – all backed by Oracle’s unmatched technical and industry expertise.”
Published in
CRO Industry News
Friday, 24 June 2011 09:21
Oracle Introduces Oracle Health Sciences Trial Center
First-of-Its-Kind Application Unifies Access to Cross-Trial Systems and Operational Information to Help Increase Productivity, Improve Trial Management
Oracle today unveiled Oracle Health Sciences Trial Center, an intelligent gateway application that delivers a unified view of actionable real-time information across multiple trials, sites and systems and provides direct access to relevant trial technologies. The innovative solution enables health sciences organizations and contract research organizations (CROs) to maximize productivity of study managers, coordinators and monitors, while strengthening collaboration and relationships between sponsors, sites, and partners.
Today, many eClinical technology users struggle to prioritize and manage tasks across a complex environment of systems spanning multiple clinical trials. Oracle Health Sciences Trial Center offers a new approach to addressing this challenge by providing a single console for users to access real-time clinical trial progress summaries and task priorities across all trials.
Oracle Health Sciences Trial Center simplifies the completion of daily tasks related to clinical trials by presenting a comprehensive and role-based view of the information and actions required to accelerate clinical trials. For example, a data manager can view data discrepancies across multiple trials at once and manage the discrepancies from a single interface, eliminating time spent toggling through multiple applications and reducing the potential for error.
In addition, by aggregating relevant information from multiple sources in real-time, Oracle Health Sciences Trial Center provides a bird’s-eye view that enables users to compare information and metrics across trials or sites to gain insight into areas for improvement or causes for concern. As a result, users can optimize work planning and execution across all trials without entering multiple studies and applications.
Oracle Health Sciences Trial Center allows users to drill down into the information and to directly access specific trial applications with a single click if more detail or action is required.
The solution also helps to strengthen relationships and collaboration between sponsors, sites, and other partners, such as CROs, by providing all parties with a common and transparent view of trial priorities, progress and activities.
Oracle Health Sciences Trial Center is pre-integrated with Oracle Health Sciences InForm GTM for more rapid time to value.
Oracle Health Sciences Trial Center is part of a comprehensive portfolio of Oracle Health Sciences Cloud Applications and is powered by the Oracle Health Sciences Cloud to help customers accelerate IT deployments, reduce resources required to maintain IT infrastructure and gain a more predictable IT spending pattern.
“Life sciences organizations and their CRO partners are focused squarely on reducing costs, improving clinical trial efficiency and accelerating insight,” said Neil de Crescenzo, vice president and general manager, Oracle Health Sciences. “However, the complexity of the networks, relationships and systems required to execute trials has made those efforts more difficult than ever. Oracle Health Sciences Trial Center provides a game-changing solution that delivers a personalized view of trial priorities, progress and daily tasks, and puts the power of unprecedented insight and the tools required to act on it at the fingertips of sponsors, CROs and site users.”
Oracle today unveiled Oracle Health Sciences Trial Center, an intelligent gateway application that delivers a unified view of actionable real-time information across multiple trials, sites and systems and provides direct access to relevant trial technologies. The innovative solution enables health sciences organizations and contract research organizations (CROs) to maximize productivity of study managers, coordinators and monitors, while strengthening collaboration and relationships between sponsors, sites, and partners.
Today, many eClinical technology users struggle to prioritize and manage tasks across a complex environment of systems spanning multiple clinical trials. Oracle Health Sciences Trial Center offers a new approach to addressing this challenge by providing a single console for users to access real-time clinical trial progress summaries and task priorities across all trials.
Oracle Health Sciences Trial Center simplifies the completion of daily tasks related to clinical trials by presenting a comprehensive and role-based view of the information and actions required to accelerate clinical trials. For example, a data manager can view data discrepancies across multiple trials at once and manage the discrepancies from a single interface, eliminating time spent toggling through multiple applications and reducing the potential for error.
In addition, by aggregating relevant information from multiple sources in real-time, Oracle Health Sciences Trial Center provides a bird’s-eye view that enables users to compare information and metrics across trials or sites to gain insight into areas for improvement or causes for concern. As a result, users can optimize work planning and execution across all trials without entering multiple studies and applications.
Oracle Health Sciences Trial Center allows users to drill down into the information and to directly access specific trial applications with a single click if more detail or action is required.
The solution also helps to strengthen relationships and collaboration between sponsors, sites, and other partners, such as CROs, by providing all parties with a common and transparent view of trial priorities, progress and activities.
Oracle Health Sciences Trial Center is pre-integrated with Oracle Health Sciences InForm GTM for more rapid time to value.
Oracle Health Sciences Trial Center is part of a comprehensive portfolio of Oracle Health Sciences Cloud Applications and is powered by the Oracle Health Sciences Cloud to help customers accelerate IT deployments, reduce resources required to maintain IT infrastructure and gain a more predictable IT spending pattern.
“Life sciences organizations and their CRO partners are focused squarely on reducing costs, improving clinical trial efficiency and accelerating insight,” said Neil de Crescenzo, vice president and general manager, Oracle Health Sciences. “However, the complexity of the networks, relationships and systems required to execute trials has made those efforts more difficult than ever. Oracle Health Sciences Trial Center provides a game-changing solution that delivers a personalized view of trial priorities, progress and daily tasks, and puts the power of unprecedented insight and the tools required to act on it at the fingertips of sponsors, CROs and site users.”
Published in
CRO Industry News
Friday, 24 June 2011 09:13
INC Research Acquires Leading Australian CRO Trident Clinical Research
INC Research, LLC, a therapeutically focused contract research organization (CRO) with a trusted process for delivering reliable results, today announced the acquisition of Trident Clinical Research to expand its clinical trials outsourcing footprint and expertise in Australia, New Zealand and India. Under the terms of the agreement, Trident will become a wholly owned affiliate of INC Research and will operate as Trident Clinical Research, an INC Research company through its offices in Sydney, Brisbane, Melbourne, Adelaide, Auckland and Mumbai. Trident’s operation in Mumbai will increase the reach of INC Research’s already sizeable clinical and data operations located in Gurgaon, India.
“Trident is an important piece in our strategy to build a sustainable CRO business that both satisfies and anticipates the global drug development needs of our customers,” said James Ogle, CEO of INC Research. “Trident has established an exceptional reputation in the region with emerging biotechs to local affiliates of global pharmaceutical companies and major principal investigator units. We are very happy to add them to our team.”
Founded in 1997, Trident has strategically grown to become one of Australia’s largest, and most respected, CROs with more than 100 employees across three countries, a full range of clinical research services and diverse therapeutic experience. With more than 500 clinical studies completed across Phase I to IV, including over 100 Phase I studies, Trident has achieved an outstanding working relationship with key Phase I units in Australia.
Based on data from the Economist Intelligence Unit, Australia offers significant cost advantages, has a highly efficient regulatory system according to timeline indicators and is a desirable location to conduct early phase clinical trials, especially when compared to the USA, UK, Germany, Japan and Singapore. Australia achieves very rapid study timelines without the need for IND or CTA. For these reasons, Australia is becoming a prime destination for conducting first-in-man and early phase clinical studies. Trident has a leading position in designing and reporting Phase I trials as well as managing the advanced Phase I facilities, fully leveraging the streamlined regulatory process in Australia for clinical trials to drive efficiencies for their customer’s projects.
“The R&D opportunities in Australia, New Zealand and India for cost-effective local and global drug development programs are enormous,” said Garth Tierney, managing director and co-founder of Trident Clinical Research, who will assume the role of Regional General Manager, Australasia at INC Research. “We bring to bear the most experienced management team and staff in the region, which underscores INC Research’s on-the-ground capabilities. We look forward to leveraging INC Research’s resources and Trusted Process methodology to enhance our services.”
For more information on INC Research’s clinical trials services in Asia Pacific, please visit www.incresearch.com/asiapac.
About INC Research, LLC
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials. The company's Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information please visit www.incresearch.com or follow us at @inc_research.
“Trident is an important piece in our strategy to build a sustainable CRO business that both satisfies and anticipates the global drug development needs of our customers,” said James Ogle, CEO of INC Research. “Trident has established an exceptional reputation in the region with emerging biotechs to local affiliates of global pharmaceutical companies and major principal investigator units. We are very happy to add them to our team.”
Founded in 1997, Trident has strategically grown to become one of Australia’s largest, and most respected, CROs with more than 100 employees across three countries, a full range of clinical research services and diverse therapeutic experience. With more than 500 clinical studies completed across Phase I to IV, including over 100 Phase I studies, Trident has achieved an outstanding working relationship with key Phase I units in Australia.
Based on data from the Economist Intelligence Unit, Australia offers significant cost advantages, has a highly efficient regulatory system according to timeline indicators and is a desirable location to conduct early phase clinical trials, especially when compared to the USA, UK, Germany, Japan and Singapore. Australia achieves very rapid study timelines without the need for IND or CTA. For these reasons, Australia is becoming a prime destination for conducting first-in-man and early phase clinical studies. Trident has a leading position in designing and reporting Phase I trials as well as managing the advanced Phase I facilities, fully leveraging the streamlined regulatory process in Australia for clinical trials to drive efficiencies for their customer’s projects.
“The R&D opportunities in Australia, New Zealand and India for cost-effective local and global drug development programs are enormous,” said Garth Tierney, managing director and co-founder of Trident Clinical Research, who will assume the role of Regional General Manager, Australasia at INC Research. “We bring to bear the most experienced management team and staff in the region, which underscores INC Research’s on-the-ground capabilities. We look forward to leveraging INC Research’s resources and Trusted Process methodology to enhance our services.”
For more information on INC Research’s clinical trials services in Asia Pacific, please visit www.incresearch.com/asiapac.
About INC Research, LLC
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials. The company's Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information please visit www.incresearch.com or follow us at @inc_research.
Published in
CRO Industry News
Friday, 24 June 2011 09:08
Chiltern Announces Additional Investment In EndPoint
Chiltern International Limited (Chiltern), a global contract research organization (CRO) announced an additional financial investment in Endpoint Clinical, Inc. (endpoint) further strengthening their strategic partnership with the company established in April 2009.
Glenn Kerkhof, Chiltern CEO, stated, “Chiltern’s decision to increase our investment in endpoint reflects our aligned vision for the future of endpoint’s PULSE platform, enabling endpoint to provide an unparalleled combination of premium client service and advanced technology solutions. Jon Dole and Tom O’Connell of endpoint have brought a new level of energy and innovation to Interactive Response Technology (IRT). Since our partnership began over a year ago, endpoint has delivered high quality, cost effective services to clients with both accuracy and speed. endpoint is successfully responding with best- in-class IVR/IWR solutions and as a result exceeding client expectations.”
Jonathan Dole, endpoint CEO, stated, “Chiltern has been an excellent partner for us over the past year, and we couldn’t be more pleased with their continued support in our vision for IRT. Chiltern’s global footprint and their overall support of our growing business have proven invaluable in moving us forward. Chiltern’s enthusiasm and investment affirms our confidence in the solutions we are bringing to the marketplace. With PULSE we are delighting our clients with our fresh and logical approach to systems development, giving our customers the agility they need in a constantly changing R&D environment.”
PULSE is endpoint’s fully configurable system which allows users to design and deploy clinical trial IRT systems at a fraction of the time and cost of other providers, was launched in January 2010. Providing both high speed of deployment and flawless quality, PULSE simultaneously designs systems that can be accessed via the phone, web, or mobile device.
Chiltern
Established in 1982, Chiltern is a leading global clinical CRO with extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern has conducted trials in more than 40 countries, employs around 1,300 people globally and offers services in Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery. www.chiltern.com.
endpoint
endpoint is an innovative company dedicated to the development of the leading Interactive Response Technology (IVR/IWR) platforms for the life sciences industry. endpoint’s founding team members have been developing IRT systems for clinical trials since 1998 and have deployed systems to small, medium and large pharma and biotech companies for domestic and global studies with experience across a broad range of therapeutic areas and global implementations. www.endpointclinical.com
Glenn Kerkhof, Chiltern CEO, stated, “Chiltern’s decision to increase our investment in endpoint reflects our aligned vision for the future of endpoint’s PULSE platform, enabling endpoint to provide an unparalleled combination of premium client service and advanced technology solutions. Jon Dole and Tom O’Connell of endpoint have brought a new level of energy and innovation to Interactive Response Technology (IRT). Since our partnership began over a year ago, endpoint has delivered high quality, cost effective services to clients with both accuracy and speed. endpoint is successfully responding with best- in-class IVR/IWR solutions and as a result exceeding client expectations.”
Jonathan Dole, endpoint CEO, stated, “Chiltern has been an excellent partner for us over the past year, and we couldn’t be more pleased with their continued support in our vision for IRT. Chiltern’s global footprint and their overall support of our growing business have proven invaluable in moving us forward. Chiltern’s enthusiasm and investment affirms our confidence in the solutions we are bringing to the marketplace. With PULSE we are delighting our clients with our fresh and logical approach to systems development, giving our customers the agility they need in a constantly changing R&D environment.”
PULSE is endpoint’s fully configurable system which allows users to design and deploy clinical trial IRT systems at a fraction of the time and cost of other providers, was launched in January 2010. Providing both high speed of deployment and flawless quality, PULSE simultaneously designs systems that can be accessed via the phone, web, or mobile device.
Chiltern
Established in 1982, Chiltern is a leading global clinical CRO with extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern has conducted trials in more than 40 countries, employs around 1,300 people globally and offers services in Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery. www.chiltern.com.
endpoint
endpoint is an innovative company dedicated to the development of the leading Interactive Response Technology (IVR/IWR) platforms for the life sciences industry. endpoint’s founding team members have been developing IRT systems for clinical trials since 1998 and have deployed systems to small, medium and large pharma and biotech companies for domestic and global studies with experience across a broad range of therapeutic areas and global implementations. www.endpointclinical.com
Published in
CRO Industry News
Friday, 24 June 2011 09:05
PRA International Expands Scandinavian Operations New Office Opening In Sweden
PRA, a leading Clinical Research Organization, announces the recent opening of a new office in Lund, Sweden to support continued growth in the area. The facility enhances local staff members’ ability to provide quality clinical services across Scandinavia.
The Swedish office is located in the thriving region of Öresund, a hub for life science businesses. Öresund is centrally situated in the Medicon Valley, widely known as one of Europe’s primary centers for biotech and pharmaceutical activity. The region is also home to several top universities, providing access to leading academic research.
PRA began operating in Sweden in 2005 and demand for services in the region has steadily increased. Over just the past three years, PRA’s Swedish staff has increased over 350%. The new office provides a base of operations for area staff, including clinical research associates, team leaders, country start‐up specialists, and other roles needed to conduct full‐service Phase II ‐ IV clinical trials. PRA’s team in Scandinavia includes, in addition to our Swedish employees, staff in Denmark, Finland and Norway.
“PRA’s new office in Sweden is an exciting development that showcases our commitment to expansion in Europe and beyond” said Dr. Ludger Langer, PRA’s Vice President of Clinical Operations in Europe, Asia‐Pacific and Africa. “Providing our local teams with a centralized location for operations strengthens our client offerings in this region.”
With over 40 offices worldwide, PRA continues to grow and expand into various regions for clinical research. The new Lund facility further demonstrates our commitment to meeting fluctuating needs of our clients in an ever‐changing clinical trials environment.
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 endpoints@ praintl.com or call our Global Headquarters at +1 (919) 786‐8200.
The Swedish office is located in the thriving region of Öresund, a hub for life science businesses. Öresund is centrally situated in the Medicon Valley, widely known as one of Europe’s primary centers for biotech and pharmaceutical activity. The region is also home to several top universities, providing access to leading academic research.
PRA began operating in Sweden in 2005 and demand for services in the region has steadily increased. Over just the past three years, PRA’s Swedish staff has increased over 350%. The new office provides a base of operations for area staff, including clinical research associates, team leaders, country start‐up specialists, and other roles needed to conduct full‐service Phase II ‐ IV clinical trials. PRA’s team in Scandinavia includes, in addition to our Swedish employees, staff in Denmark, Finland and Norway.
“PRA’s new office in Sweden is an exciting development that showcases our commitment to expansion in Europe and beyond” said Dr. Ludger Langer, PRA’s Vice President of Clinical Operations in Europe, Asia‐Pacific and Africa. “Providing our local teams with a centralized location for operations strengthens our client offerings in this region.”
With over 40 offices worldwide, PRA continues to grow and expand into various regions for clinical research. The new Lund facility further demonstrates our commitment to meeting fluctuating needs of our clients in an ever‐changing clinical trials environment.
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 endpoints@ praintl.com or call our Global Headquarters at +1 (919) 786‐8200.
Published in
CRO Industry News
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