CRO Industry News
Tuesday, 05 April 2011 12:03
CRF Health To Host Two-Part Webinar Session On CRO-ePRO Best Practices
CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry today announced that it will host a free two-part webinar series focusing on CRO-ePRO Delivery. Gregg Jewett, Senior Director of Strategic Alliances and Partnerships, CRF Health, will lead these two sessions. The webinar details are as follows:
Session Titles: “CRO ePRO Delivery – Parts I & II”
Dates: Part I, Thursday, March 17, 2011 and Part II, Thursday April 21, 2011
Time: 11:00 a.m. EDT
Duration: 1 hour
Registration: http://www.crfhealth.com/webcasts.php
Topics to be covered:
http://www.crfhealth.com/webcasts.php
Mary Briggs, VP Global Sales & Marketing commented, “Nearly 600 clinical research professionals participate in our monthly webinar series every year and we are looking forward to including this important CRO topic in March and April. Our longstanding webinar series supports CRF Health’s objective of educating the pharmaceutical industry on patient reported outcomes, and raising the visibility of ePRO within the clinical trials sector.”
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 60 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 US, 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.
Session Titles: “CRO ePRO Delivery – Parts I & II”
Dates: Part I, Thursday, March 17, 2011 and Part II, Thursday April 21, 2011
Time: 11:00 a.m. EDT
Duration: 1 hour
Registration: http://www.crfhealth.com/webcasts.php
Topics to be covered:
- CRO and ePRO trends
- Best practices for CROs and ePRO vendors
- Tips on how to ensure a smooth ePRO delivery through a qualified CRO
http://www.crfhealth.com/webcasts.php
Mary Briggs, VP Global Sales & Marketing commented, “Nearly 600 clinical research professionals participate in our monthly webinar series every year and we are looking forward to including this important CRO topic in March and April. Our longstanding webinar series supports CRF Health’s objective of educating the pharmaceutical industry on patient reported outcomes, and raising the visibility of ePRO within the clinical trials sector.”
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 60 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 US, 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
Tuesday, 05 April 2011 11:58
Chiltern Expands European Operations With A New Office In The Netherlands
Chiltern International Limited (Chiltern), a global clinical contract research organization (CRO) announced that it has opened a new office in the Netherlands, appointing Angela Pasma as the Netherlands’ Country Manager.
Mr. Maurizio Passanisi, Chiltern’s Director of the Benelux Region commented, “The Netherlands continues to be an excellent place for clinical research with experienced investigators as well as highly regarded international key opinion leaders, all adhering to the highest of medical standards.
“Furthermore, in leading the growth of the Chiltern office in Leiden, Ms. Pasma brings a wealth of knowledge and experience to support Chiltern’s growing full service clinical and flexible staffing services in the region.”
Pasma added, “Having already cultivated positive relationships with clients and colleagues in the region, we look forward to expanding our operations here to further serve our clients’ needs. The Leiden office is well situated geographically to support this effort.”
Armand Czaplinski, Executive Director, Global Country Management for Chiltern, further explained, “Chiltern’s expansion in the Netherlands aligns perfectly with our primary goal to deliver expert, high quality services around the world and demonstrates our ongoing commitment to regional expansion in order to serve our clients’ needs globally.”
About 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. Further information is available at www.chiltern.com.
Mr. Maurizio Passanisi, Chiltern’s Director of the Benelux Region commented, “The Netherlands continues to be an excellent place for clinical research with experienced investigators as well as highly regarded international key opinion leaders, all adhering to the highest of medical standards.
“Furthermore, in leading the growth of the Chiltern office in Leiden, Ms. Pasma brings a wealth of knowledge and experience to support Chiltern’s growing full service clinical and flexible staffing services in the region.”
Pasma added, “Having already cultivated positive relationships with clients and colleagues in the region, we look forward to expanding our operations here to further serve our clients’ needs. The Leiden office is well situated geographically to support this effort.”
Armand Czaplinski, Executive Director, Global Country Management for Chiltern, further explained, “Chiltern’s expansion in the Netherlands aligns perfectly with our primary goal to deliver expert, high quality services around the world and demonstrates our ongoing commitment to regional expansion in order to serve our clients’ needs globally.”
About 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. Further information is available at www.chiltern.com.
Published in
CRO Industry News
Thursday, 24 March 2011 07:06
Comprehensive NeuroScience Announces New Company Name and Tagline
To better reflect its diverse therapeutic expertise, Comprehensive NeuroScience, Inc. (CNS), a strategic clinical research organization delivering high-quality clinical development services from early proof-of-concept through commercialization, is pleased to announce its plans to roll out the new company name, Comprehensive Clinical Development, along with its tagline, “The Proof is in the Performance.” Under its new name and tagline, Comprehensive Clinical Development will continue to deliver superior quality CRO services in partnership with sponsors who can be confident that their projects will be done correctly and on time.
Comprehensive Clinical Development adopted the tagline, “The Proof is in the Performance,” as part of their ongoing commitment and ability to advance compounds quickly and efficiently. As a trusted partner, Comprehensive Clinical Development provides complete Phase I through Phase IV clinical and non-clinical development services to biopharmaceutical clients.
“Our decision to change the company name and tagline was the result of intense evaluation and ongoing strategy to better position Comprehensive Clinical Development and articulate our therapeutic depth and breadth,” stated Comprehensive Clinical Development President Ali Craig-Rodriguez. “The name and tagline changes better reflect who we are and what we provide; while our name may be changing, our unwavering commitment to our internal and external customers has not changed.”
Comprehensive Clinical Development offers full-service capabilities and therapeutic expertise in numerous indications, including, but not limited to, CNS, dermatology, diabetes, infectious disease, obesity, and postmenopausal women, and collects early efficacy data across these populations.
Offering CRO services both of developmental and clinical conduct, Comprehensive Clinical Development leverages the diversity of its service networks to provide biopharmaceutical clients with exceptional quality and cost-effective trial management. Along with early and late phase site clinical conduct, Comprehensive Clinical Development provides a full range of services from protocol writing through final clinical study reporting.
About Comprehensive Clinical Development
Comprehensive Clinical Development is a strategic clinical research partner providing a full range of clinical development services in various therapeutic areas with an outstanding record for consistently delivering quality and success on time and within budget. Comprehensive Clinical Development holds a solid track record of collecting early efficacy data across various patient populations, and offers distinct capabilities in clinical research. Comprehensive Clinical Development also offers CRO services to provide biopharmaceutical clients exceptional quality and cost-effective trial management. For more information about Comprehensive Clinical Development, visit www.comprehensivecro.com.
Comprehensive Clinical Development adopted the tagline, “The Proof is in the Performance,” as part of their ongoing commitment and ability to advance compounds quickly and efficiently. As a trusted partner, Comprehensive Clinical Development provides complete Phase I through Phase IV clinical and non-clinical development services to biopharmaceutical clients.
“Our decision to change the company name and tagline was the result of intense evaluation and ongoing strategy to better position Comprehensive Clinical Development and articulate our therapeutic depth and breadth,” stated Comprehensive Clinical Development President Ali Craig-Rodriguez. “The name and tagline changes better reflect who we are and what we provide; while our name may be changing, our unwavering commitment to our internal and external customers has not changed.”
Comprehensive Clinical Development offers full-service capabilities and therapeutic expertise in numerous indications, including, but not limited to, CNS, dermatology, diabetes, infectious disease, obesity, and postmenopausal women, and collects early efficacy data across these populations.
Offering CRO services both of developmental and clinical conduct, Comprehensive Clinical Development leverages the diversity of its service networks to provide biopharmaceutical clients with exceptional quality and cost-effective trial management. Along with early and late phase site clinical conduct, Comprehensive Clinical Development provides a full range of services from protocol writing through final clinical study reporting.
About Comprehensive Clinical Development
Comprehensive Clinical Development is a strategic clinical research partner providing a full range of clinical development services in various therapeutic areas with an outstanding record for consistently delivering quality and success on time and within budget. Comprehensive Clinical Development holds a solid track record of collecting early efficacy data across various patient populations, and offers distinct capabilities in clinical research. Comprehensive Clinical Development also offers CRO services to provide biopharmaceutical clients exceptional quality and cost-effective trial management. For more information about Comprehensive Clinical Development, visit www.comprehensivecro.com.
Published in
CRO Industry News
Friday, 04 March 2011 06:23
Ricerca Announces Strategic Collaboration Agreement With Fulcrum Pharma,
Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, is pleased to announce a strategic partnership with Fulcrum Pharma, an Aptiv Solutions company, a leading provider of drug development consulting and regulatory services essential to progress a development program from research to product approval. The collaboration provides unique, value-added capabilities to biopharmaceutical companies by creating a streamlined and efficient process to move a candidate from development to clinical evaluation.
“The Fulcrum Pharma collaboration is an attractive and exciting proposition for Ricerca and our clients. Fulcrum Pharma brings deep experience in IND authorship and regulatory approval, which fits well with Ricerca’s preclinical services in discovery pharmacology, chemical development and drug safety assessment. The relationship greatly expands our ability to serve our clients who are preparing for regulatory submission anywhere in the world,” commented Ian Lennox, CEO of Ricerca.
Ricerca Biosciences provides the 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. Fulcrum Pharma, is a global leader in the provision of strategic and operational regulatory support to assist clients in the authorship and approval of regulatory submissions.
“The collaboration offers our early stage clients a streamlined service to move efficiently through preclinical development to creation of high quality IND submissions,” said Patrick K. Donnelly, Aptiv Solutions’ Chairman and CEO. “This approach, coupled with our expertise in adaptive clinical trial design, will provide our clients with the ability to accelerate the development of their products and stay ahead of the competition.”
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.
About Fulcrum Pharma, an Aptiv Solutions company
Fulcrum Pharma is a professional service company providing clients with expert solutions for the development of therapeutic products. The Company provides a full range of drug development, expert consulting, safety and regulatory expertise essential to progress a development program from research to product approval.
About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. Aptiv Solutions integrates the resources and expertise of six recently merged companies: Averion International, Trio Clinical Research, Fulcrum Pharma, ClinResearch, Niphix and ADDPLAN.
Aptiv Solutions provides innovative, comprehensive and proven product development capabilities, built on an extensive portfolio of services and a worldwide team of more than 700 professionals.
“The Fulcrum Pharma collaboration is an attractive and exciting proposition for Ricerca and our clients. Fulcrum Pharma brings deep experience in IND authorship and regulatory approval, which fits well with Ricerca’s preclinical services in discovery pharmacology, chemical development and drug safety assessment. The relationship greatly expands our ability to serve our clients who are preparing for regulatory submission anywhere in the world,” commented Ian Lennox, CEO of Ricerca.
Ricerca Biosciences provides the 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. Fulcrum Pharma, is a global leader in the provision of strategic and operational regulatory support to assist clients in the authorship and approval of regulatory submissions.
“The collaboration offers our early stage clients a streamlined service to move efficiently through preclinical development to creation of high quality IND submissions,” said Patrick K. Donnelly, Aptiv Solutions’ Chairman and CEO. “This approach, coupled with our expertise in adaptive clinical trial design, will provide our clients with the ability to accelerate the development of their products and stay ahead of the competition.”
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.
About Fulcrum Pharma, an Aptiv Solutions company
Fulcrum Pharma is a professional service company providing clients with expert solutions for the development of therapeutic products. The Company provides a full range of drug development, expert consulting, safety and regulatory expertise essential to progress a development program from research to product approval.
About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. Aptiv Solutions integrates the resources and expertise of six recently merged companies: Averion International, Trio Clinical Research, Fulcrum Pharma, ClinResearch, Niphix and ADDPLAN.
Aptiv Solutions provides innovative, comprehensive and proven product development capabilities, built on an extensive portfolio of services and a worldwide team of more than 700 professionals.
Published in
CRO Industry News
Friday, 04 March 2011 06:14
Chiltern – Spectratox Drug Phototoxicity Collaboration Celebrates 25 Years
The staffs of Chiltern International Limited (Chiltern), a global contract research organization (CRO), and Spectratox Limited, celebrate the 25 year mark of their successful collaboration in Drug Phototoxicity.
Chiltern Early Phase and Spectratox have worked together using a validated and regulatory accepted in vivo human study method for the assessment of drug phototoxicity. The history of this collaboration can be traced through their multiple publications in peer reviewed journals.
“The success story of this methodology is not just measured in publications,” stated Dr Brian Sanderson, Medical Director, Chiltern Early Phase. “It is measured in the success we have had in helping new drugs continue their developmental journey for areas of therapeutic need.”
Professor James Ferguson, Head of the Academic Department of Dermatology, University of Dundee, and CEO of Spectratox, explained, “The evolution of randomized controlled trials has been in response to industry and regulatory requirements. Our trials, which tend to be conducted prior to Phase 3, produce data that defines the phototoxic risk in man in terms of severity and causal wavelengths as well as providing an understanding of the likelihood of ocular phototoxicity. Where phototoxicity is found, advice on protective measures to enable future development of the compound is an important aspect of our work.”
Dr Sanderson added, “New study designs have been introduced to act as initial “screening” in man for drugs with potential phototoxicity. The new designs have evolved in response to the growing demand to assess this earlier in clinical drug development. The benefits are savings in both time and cost whilst remaining scientifically robust.”
Glenn Kerkhof, Chiltern CEO, commented, “This 25 year collaboration is cause for celebration when we look back and realize the successes reached as well as what is presently being accomplished together. We very much look forward to what the next 25 years will bring in advancing drug development processes.”
About Chiltern:
Established in 1982, Chiltern is a leading global Contract Research Organization with extensive experience conducting and staffing international Phase I to Phase IV clinical trials across a broad range of therapeutic areas for a wide variety of clients. Chiltern has conducted trials in more than 40 countries, has 24 offices and legal entities within 20 countries, resources in 37 countries and employs nearly 1,400 people globally. Chiltern provides Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions services. Further information: www.chiltern.com.
About Spectratox:
Spectratox, although formally established in 2008, came about from a group of staff within the Photobiology Unit who had been collaborating with the Chiltern staff on drug phototoxicity work in Scotland since the mid 1980s. Together they developed an evidence-based methodology for studying phototoxicity in clinical volunteers. Professor Ferguson has 30 years experience advising on the need for such work. The staff at Spectratox are also expert in pre-clinical laboratory data analysis; clinical ‘healthy volunteer’ studies and post-study testing; advice on product labelling and clinical management.
Phototoxicity testing is carried out on the premises of the National Photobiology Unit, Ninewells Hospital and Medical School, a part of NHS Tayside (although Spectratox Ltd. is an independent company). Further information: www.spectratox.co.uk.
Chiltern Early Phase and Spectratox have worked together using a validated and regulatory accepted in vivo human study method for the assessment of drug phototoxicity. The history of this collaboration can be traced through their multiple publications in peer reviewed journals.
“The success story of this methodology is not just measured in publications,” stated Dr Brian Sanderson, Medical Director, Chiltern Early Phase. “It is measured in the success we have had in helping new drugs continue their developmental journey for areas of therapeutic need.”
Professor James Ferguson, Head of the Academic Department of Dermatology, University of Dundee, and CEO of Spectratox, explained, “The evolution of randomized controlled trials has been in response to industry and regulatory requirements. Our trials, which tend to be conducted prior to Phase 3, produce data that defines the phototoxic risk in man in terms of severity and causal wavelengths as well as providing an understanding of the likelihood of ocular phototoxicity. Where phototoxicity is found, advice on protective measures to enable future development of the compound is an important aspect of our work.”
Dr Sanderson added, “New study designs have been introduced to act as initial “screening” in man for drugs with potential phototoxicity. The new designs have evolved in response to the growing demand to assess this earlier in clinical drug development. The benefits are savings in both time and cost whilst remaining scientifically robust.”
Glenn Kerkhof, Chiltern CEO, commented, “This 25 year collaboration is cause for celebration when we look back and realize the successes reached as well as what is presently being accomplished together. We very much look forward to what the next 25 years will bring in advancing drug development processes.”
About Chiltern:
Established in 1982, Chiltern is a leading global Contract Research Organization with extensive experience conducting and staffing international Phase I to Phase IV clinical trials across a broad range of therapeutic areas for a wide variety of clients. Chiltern has conducted trials in more than 40 countries, has 24 offices and legal entities within 20 countries, resources in 37 countries and employs nearly 1,400 people globally. Chiltern provides Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions services. Further information: www.chiltern.com.
About Spectratox:
Spectratox, although formally established in 2008, came about from a group of staff within the Photobiology Unit who had been collaborating with the Chiltern staff on drug phototoxicity work in Scotland since the mid 1980s. Together they developed an evidence-based methodology for studying phototoxicity in clinical volunteers. Professor Ferguson has 30 years experience advising on the need for such work. The staff at Spectratox are also expert in pre-clinical laboratory data analysis; clinical ‘healthy volunteer’ studies and post-study testing; advice on product labelling and clinical management.
Phototoxicity testing is carried out on the premises of the National Photobiology Unit, Ninewells Hospital and Medical School, a part of NHS Tayside (although Spectratox Ltd. is an independent company). Further information: www.spectratox.co.uk.
Published in
CRO Industry News
Friday, 04 March 2011 06:11
CRF Health Holds A Session On The Topic ePRO Data Collection Methods
CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry will be joined by industry colleagues at the DIA EuroMeeting for a session on the topic ePRO data collection methods.
The meeting takes place March 28-30, 2011 in Geneva, Switzerland. The title of the session is “Comparing ePRO Technologies: What Works?” The Session Chair will be Ingrid Klingmann, CRF Health, Clinical Advisor. Rauha Tulkki-Wilke, Director Product Management, CRF Health will deliver the introduction which will discuss the rapidly evolving techniques utilized in ePRO technology and provide attendees with an overview of practical considerations for utilizing different ePRO technologies ranging from PDA and mobile phones to tablet PCs and the web. Results from tests with people with a healthcare or technology background and from cognitive and usability interviews with patients in a real-world setting as well as experiences made in clinical trials will be presented and discussed in the session.
In addition to presenting at the session, CRF Health recently presented “Which ePRO Solution is Right for Your Clinical Study” at DIA’s Annual Workshop in Japan for Clinical Data Management in January, and will present at DIA’s annual meeting in June on these topics “Advanced Clinical Monitoring and Data Management with ePRO” and “Web-Based Assessments: The Internet is an Emerging Modality in PRO.”
Mary Briggs, VP Global Sales & Marketing comments, “We are very pleased to present on various global ePRO trends at DIA events in Asia, Europe, and the US in 2011. These events support CRF Health’s objective of educating the pharmaceutical industry on patient reported outcomes, and raising the visibility of ePRO within the clinical trials sector.”
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 60 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 US, 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.
The meeting takes place March 28-30, 2011 in Geneva, Switzerland. The title of the session is “Comparing ePRO Technologies: What Works?” The Session Chair will be Ingrid Klingmann, CRF Health, Clinical Advisor. Rauha Tulkki-Wilke, Director Product Management, CRF Health will deliver the introduction which will discuss the rapidly evolving techniques utilized in ePRO technology and provide attendees with an overview of practical considerations for utilizing different ePRO technologies ranging from PDA and mobile phones to tablet PCs and the web. Results from tests with people with a healthcare or technology background and from cognitive and usability interviews with patients in a real-world setting as well as experiences made in clinical trials will be presented and discussed in the session.
In addition to presenting at the session, CRF Health recently presented “Which ePRO Solution is Right for Your Clinical Study” at DIA’s Annual Workshop in Japan for Clinical Data Management in January, and will present at DIA’s annual meeting in June on these topics “Advanced Clinical Monitoring and Data Management with ePRO” and “Web-Based Assessments: The Internet is an Emerging Modality in PRO.”
Mary Briggs, VP Global Sales & Marketing comments, “We are very pleased to present on various global ePRO trends at DIA events in Asia, Europe, and the US in 2011. These events support CRF Health’s objective of educating the pharmaceutical industry on patient reported outcomes, and raising the visibility of ePRO within the clinical trials sector.”
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 60 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 US, 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
Friday, 04 March 2011 05:57
MPI Research Names Derrington President and COO
MPI Research, the largest single-site preclinical contract research organization worldwide, is pleased to announce that Tim Derrington is joining the company as President and Chief Operating Officer, effective March 7, 2011.
Derrington brings a wealth of international operational and industry leadership, experience, and specific knowledge for maximizing operational performance, business development, and strategic partnerships. He most recently was Chairman and CEO of Axient Research, a CRO developing clinical research solutions to deliver reliable and accurate patient data to accelerate the development of safe and effective drug and medical treatments.
Prior to Axient, Derrington was the CEO of BioReliance Corp (Invitrogen Corp), a research company providing biologic testing and manufacturing and toxicology services to global pharmaceutical and biopharmaceutical companies that span the product cycle from early preclinical development to licensed production. Over the duration of his career, he has held management positions with Quintiles Transnational Corp (Senior Vice President, Corporate Development); Quintiles Laboratories Worldwide (Chief Operating Officer); Mayo Clinic (Administrative Director-Clinical Trials); and Shell UK Ventures (Managing Director and Project Manager).
Derrington is a graduate of Seale Hayne College, England, and holds an MBA from Henley Management College, Oxfordshire, England.
According to MPI Research Chairman and CEO, William U. Parfet, “As President and COO, Tim Derrington will help us scale our operations and expand our presence globally. He represents the depth that is essential to our top management team, and his knowledge, leadership ability, and industry experience will be among our most valuable assets.”
Please join us in welcoming Tim Derrington to MPI Research!
MPI Research, with global headquarters in Mattawan, Michigan, provides safety evaluation, discovery, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Scientific knowledge and experience, responsiveness, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world. Learn more about how we can exceed your expectations at www.mpiresearch.com.
Derrington brings a wealth of international operational and industry leadership, experience, and specific knowledge for maximizing operational performance, business development, and strategic partnerships. He most recently was Chairman and CEO of Axient Research, a CRO developing clinical research solutions to deliver reliable and accurate patient data to accelerate the development of safe and effective drug and medical treatments.
Prior to Axient, Derrington was the CEO of BioReliance Corp (Invitrogen Corp), a research company providing biologic testing and manufacturing and toxicology services to global pharmaceutical and biopharmaceutical companies that span the product cycle from early preclinical development to licensed production. Over the duration of his career, he has held management positions with Quintiles Transnational Corp (Senior Vice President, Corporate Development); Quintiles Laboratories Worldwide (Chief Operating Officer); Mayo Clinic (Administrative Director-Clinical Trials); and Shell UK Ventures (Managing Director and Project Manager).
Derrington is a graduate of Seale Hayne College, England, and holds an MBA from Henley Management College, Oxfordshire, England.
According to MPI Research Chairman and CEO, William U. Parfet, “As President and COO, Tim Derrington will help us scale our operations and expand our presence globally. He represents the depth that is essential to our top management team, and his knowledge, leadership ability, and industry experience will be among our most valuable assets.”
Please join us in welcoming Tim Derrington to MPI Research!
MPI Research, with global headquarters in Mattawan, Michigan, provides safety evaluation, discovery, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Scientific knowledge and experience, responsiveness, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world. Learn more about how we can exceed your expectations at www.mpiresearch.com.
Published in
CRO Industry News
Friday, 04 March 2011 05:51
Celerion adds USP 797-compliant Clean Room
Celerion, the premier provider of innovative early stage drug development solutions, announces the completion of a Clean Room and pharmacist certification to comply with USP 797 guidelines. This enables in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution. The sterile preparation and administration allows clients a one-stop option thereby saving time and money.
A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP <797> Clean Room allows for all types of complex extemporaneous compounding for low, medium and high risk investigational compounds. This allows Celerion to take a client’s API, develop customized dosing and compounding that enable very selective dose levels to be administered. This solution combined with our experience in delivering early stage adaptive trial designed studies will allow clients to reach clinical proof-of-concept (PoC) faster.
“The addition of the USP 797 Clean Room continues to demonstrate Celerion’s commitment to implement innovative solutions to generate critical data to enable decisions in drug development to be made earlier” said Phil Bach, Vice President of Clinical Research at Celerion. “The clean room when combined with our Lincoln, Nebraska, facility’s radiolabel license, allows Celerion to offer execution of Phase 0, microtracer and microdosing studies producing data typically not available until later in drug development.”
The unique design of this Clean Room includes three separate areas, one ante-room that serves two individual clean rooms. One clean room is a dedicated microtracer area which contains a Class A2 Biological Safety Cabinet for radiolabeled microtracer compounding. An additional clean room contains a laminar flow hood for traditional IV compounding. Both clean rooms are ISO 7, attached to an ISO 8 ante-room and are used for sterile compounding.
About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. Formed through the acquisition of the early stage development operations of MDS Pharma 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. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.
A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP <797> Clean Room allows for all types of complex extemporaneous compounding for low, medium and high risk investigational compounds. This allows Celerion to take a client’s API, develop customized dosing and compounding that enable very selective dose levels to be administered. This solution combined with our experience in delivering early stage adaptive trial designed studies will allow clients to reach clinical proof-of-concept (PoC) faster.
“The addition of the USP 797 Clean Room continues to demonstrate Celerion’s commitment to implement innovative solutions to generate critical data to enable decisions in drug development to be made earlier” said Phil Bach, Vice President of Clinical Research at Celerion. “The clean room when combined with our Lincoln, Nebraska, facility’s radiolabel license, allows Celerion to offer execution of Phase 0, microtracer and microdosing studies producing data typically not available until later in drug development.”
The unique design of this Clean Room includes three separate areas, one ante-room that serves two individual clean rooms. One clean room is a dedicated microtracer area which contains a Class A2 Biological Safety Cabinet for radiolabeled microtracer compounding. An additional clean room contains a laminar flow hood for traditional IV compounding. Both clean rooms are ISO 7, attached to an ISO 8 ante-room and are used for sterile compounding.
About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. Formed through the acquisition of the early stage development operations of MDS Pharma 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. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.
Published in
CRO Industry News
Thursday, 24 February 2011 07:27
Impact Analytical Expands Service Offerings and Adds Technical Personnel to Meet Growing Demand
Impact Analytical, a full-service contract, analytical testing laboratory, is pleased to announce the addition of four technical personnel in conjunction with the Company’s expansion of services. The increase in staff experts and expanded services and techniques are both a result of Impact Analytical’s growing demand.
The new services added to Impact Analytical’s already extensive list include:
Technical expertise, strict regulatory requirements and quality compliance work together in Impact Analytical’s product to market process.
In addition to the new service offerings, Impact Analytical adds over 75 years of combined experience with the hire of the following experts:
"Our new elemental analysis laboratory, improved techniques and purchased equipment will advance Impact Analytical’s ability to provide efficient and cost effective analytical testing to clients," stated Eric Hill, business marketing manager at Impact Analytical. "Bringing on more technicians and scientists allows us to offer an increased level of support to our customers, ensuring communication and collaboration are always a priority."
Impact Analytical works with more than 300 companies around the world in a variety of industries including pharmaceuticals, plastics, consumer products, medical devices, packaging, automotive and specialty chemical.
Visit Impact Analytical at the Medical Design & Manufacturing (MD&M) West Exposition, February 8-10, 2011, in Anaheim, California, at booth #845.
About Impact Analytical
Impact Analytical is a contract testing laboratory established within the Michigan Molecular Institute in 1995. The research institute was founded in Midland, Michigan, to promote the advancement of fundamental scientific research in the areas of chemical and polymer science and is now dedicated to advanced research, development and commercialization of polymer science and technology. More information about Impact Analytical is available by visiting www.impactanalytical.com.
The new services added to Impact Analytical’s already extensive list include:
- Elemental Analysis Laboratory—in-house testing with mass balance, impurity analysis, testing for fillers, salts and USP 2232 and 233
- Ultra Performance Liquid Chromatography (UPLC)—superior resolution and analysis speed offering method conversion, development and validation services
- Stability Testing—on-site chambers evaluate time, temperature and humidity
- Tablet Dissolution—test bioavailability, therapeutic effectiveness and uniform product quality
Technical expertise, strict regulatory requirements and quality compliance work together in Impact Analytical’s product to market process.
In addition to the new service offerings, Impact Analytical adds over 75 years of combined experience with the hire of the following experts:
- Tom Sanders—Associate scientist, thermal and mechanical properties
- Sheron Walker—Analytical technologist II, liquid separations laboratory
- Debbie Beuthin—Analytical technologist II, gas separations laboratory
- Lee Koski—Consultant, elemental analysis laboratory
"Our new elemental analysis laboratory, improved techniques and purchased equipment will advance Impact Analytical’s ability to provide efficient and cost effective analytical testing to clients," stated Eric Hill, business marketing manager at Impact Analytical. "Bringing on more technicians and scientists allows us to offer an increased level of support to our customers, ensuring communication and collaboration are always a priority."
Impact Analytical works with more than 300 companies around the world in a variety of industries including pharmaceuticals, plastics, consumer products, medical devices, packaging, automotive and specialty chemical.
Visit Impact Analytical at the Medical Design & Manufacturing (MD&M) West Exposition, February 8-10, 2011, in Anaheim, California, at booth #845.
About Impact Analytical
Impact Analytical is a contract testing laboratory established within the Michigan Molecular Institute in 1995. The research institute was founded in Midland, Michigan, to promote the advancement of fundamental scientific research in the areas of chemical and polymer science and is now dedicated to advanced research, development and commercialization of polymer science and technology. More information about Impact Analytical is available by visiting www.impactanalytical.com.
Published in
CRO Industry News
Thursday, 24 February 2011 07:22
DaVita Clinical Research Demonstrates Renal and Scientific Leadership in 2010
DaVita Clinical Research® (DCR®), a provider of clinical research and diagnostic laboratory services, demonstrated its scientific leadership in 2010 by opening its Central Laboratory, expanding its Health Economics leadership, and participating and presenting in a multitude of posters and abstracts at top renal industry meetings.
DCR led the industry in the number of renal patients enrolled in clinical trials, totaling 2,579 active patients. The company’s unsurpassed knowledge, skill and experience relating to kidney disease and scientific leadership is comprised of some of the world’s top nephrologists with more than 80 years of experience in renal research.
“We are pleased and very fortunate for the direction 2010 has led DCR,” stated DCR President Chris Rucker. “Our organization’s devotion to this industry is what helps us excel, and we are eager to continue with our efforts throughout 2011.”
DCR’s Central Laboratory, which opened in September 2010, features the latest in analytical methodology and technology. Investments in both equipment and its over 47,000-square-foot facility allow for generating a daily test volume of approximately 144,000 tests on 60,000 samples per day. With sincere dedication to conducting each client project on time, DCR holds an impressive rate of delivery at 99.8 percent. Having developed the latest milestone at the Central Laboratory – green packaging for samples – DCR combines its high delivery rate with a cost-effective and environmentally friendly method of shipping.
The DaVita® network, including DaVita, Inc., DCR and its renal-focused counterparts and partners were selected to represent a total of 56 posters and deliver five oral presentations at the American Society of Nephrology Annual Meeting and Scientific Exposition (ASN). DCR also had a strong presence at the Annual Dialysis Conference (ADC), delivering 20 presentations to an international group of practitioners and researchers. These numbers represent a notable presence by DaVita and the company’s related entities at both ASN and ADC, representing impactful research with great depth and thought leadership. Along with the company’s impressive number of abstracts and presentations, DCR had 23 articles published in peer-reviewed journals.
About DaVita Clinical Research
Davita Clinical Research® (DCR®) is committed to advancing the knowledge and practice of kidney care. DCR brings extensive knowledge, skill, and expertise to pharmaceutical research, enabling the success of their clients’ clinical trials. Their 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 is 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 Inc.
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services and education to patients with chronic kidney failure and end stage renal disease. As of December 31, 2010, DaVita operated or provided administrative services at 1,612 dialysis facilities, serving approximately 125,000 patients. DaVita develops, participates in and donates to numerous programs dedicated to transforming communities and creating positive, sustainable change for children, families and our environment. The company’s leadership development initiatives and corporate social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu, among others. For more information, please visit www.davita.com.
DCR led the industry in the number of renal patients enrolled in clinical trials, totaling 2,579 active patients. The company’s unsurpassed knowledge, skill and experience relating to kidney disease and scientific leadership is comprised of some of the world’s top nephrologists with more than 80 years of experience in renal research.
“We are pleased and very fortunate for the direction 2010 has led DCR,” stated DCR President Chris Rucker. “Our organization’s devotion to this industry is what helps us excel, and we are eager to continue with our efforts throughout 2011.”
DCR’s Central Laboratory, which opened in September 2010, features the latest in analytical methodology and technology. Investments in both equipment and its over 47,000-square-foot facility allow for generating a daily test volume of approximately 144,000 tests on 60,000 samples per day. With sincere dedication to conducting each client project on time, DCR holds an impressive rate of delivery at 99.8 percent. Having developed the latest milestone at the Central Laboratory – green packaging for samples – DCR combines its high delivery rate with a cost-effective and environmentally friendly method of shipping.
The DaVita® network, including DaVita, Inc., DCR and its renal-focused counterparts and partners were selected to represent a total of 56 posters and deliver five oral presentations at the American Society of Nephrology Annual Meeting and Scientific Exposition (ASN). DCR also had a strong presence at the Annual Dialysis Conference (ADC), delivering 20 presentations to an international group of practitioners and researchers. These numbers represent a notable presence by DaVita and the company’s related entities at both ASN and ADC, representing impactful research with great depth and thought leadership. Along with the company’s impressive number of abstracts and presentations, DCR had 23 articles published in peer-reviewed journals.
About DaVita Clinical Research
Davita Clinical Research® (DCR®) is committed to advancing the knowledge and practice of kidney care. DCR brings extensive knowledge, skill, and expertise to pharmaceutical research, enabling the success of their clients’ clinical trials. Their 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 is 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 Inc.
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services and education to patients with chronic kidney failure and end stage renal disease. As of December 31, 2010, DaVita operated or provided administrative services at 1,612 dialysis facilities, serving approximately 125,000 patients. DaVita develops, participates in and donates to numerous programs dedicated to transforming communities and creating positive, sustainable change for children, families and our environment. The company’s leadership development initiatives and corporate social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu, among others. For more information, please visit www.davita.com.
Published in
CRO Industry News
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