Theorem Clinical Research

Articles Published in 2009

DIA Offers Clinical Safety and Pharmacovigilance Certification

Wednesday, December 30, 2009 07:21 AM

The Drug Information Association (DIA) recently launched its Clinical Safety and Pharmacovigilance Certificate Program—the organization’s third certificate program for clinical research professionals.

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ZeeCRO Sells Bioanalytical Division

Tuesday, December 29, 2009 07:42 AM

Cary, N.C.-based contract research organization (CRO) ZeeCRO, formerly AAIPharma Services, sold its bioanalytical division to Kansas Venture Capital, Inc., (KVCI) for an undisclosed sum. KCVI plans to grow the bioanalytical business, which is now a new company, KCAS, Inc.

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AAHRPP Changes Process, Awards Fewer Accreditations

Monday, December 28, 2009 08:30 AM

Organizations accredited by the Accreditation of Human Research Protection Programs (AAHRPP) will soon be able to go longer between accreditation renewals as part of a number of process changes effective January 1.  

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Phase Forward Appoints First Chief Privacy Officer

Thursday, December 24, 2009 07:40 AM

Phase Forward appointed long-time employee Michael Owings to the new role of chief privacy officer. Owings will oversee all privacy and data protection processes affecting Phase Forward’s customers and employees, and ensure compliance with all relevant regulations. He will also continue his duties as vice president, quality and regulatory compliance—a title he’s held since 2004.

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Guest Commentary: SaaS and Pharmacovigilance—A Vital Partnership

Wednesday, December 23, 2009 07:36 AM

Michael Reynolds, APCER Pharma

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PPD and DiabetesAmerica Enter Exclusive Partnership

Tuesday, December 22, 2009 07:37 AM

Wilmington, N.C.-based PPD has entered into an exclusive partnership with Houston, Texas-based DiabetesAmerica to provide clinical research training and support to the company’s 17 clinical trial centers across Texas and Arizona.

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ICON to Create Translational Medicine Unit in UK

Monday, December 21, 2009 07:53 AM

Dublin-based contract research organization (CRO) ICON is preparing to open a new hospital-based translational medicine unit in the UK—the result of a partnership with the Central Manchester University Hospitals Foundation (CMFT).

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ICON Founder to Retire as Board Chairman

Friday, December 18, 2009 07:23 AM

John Climax will retire as board chairman of Dublin-based contract research organization (CRO) ICON, effective December 31. Climax founded the company 19 years ago. He will remain as a board member, while Bruce Given steps into the role of chairman. Given, a healthcare products consultant, has served on ICON’s board for five years. Prior to becoming a consultant, he was president and CEO of Encysive Pharmaceuticals.

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Covance Opens Offices in Seoul, Mumbai

Thursday, December 17, 2009 07:42 AM

Covance recently opened new clinical development offices in Seoul, South Korea, and Mumbai, India, building on the contract research organization’s (CRO) two-decade history in the Asia-Pacific region.

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SynRG Becomes First Russian Member of European Forum for Good Clinical Practice

Wednesday, December 16, 2009 06:44 AM

Russia-based contract research organization (CRO) SynRG recently became the first Russian member of the European Forum for Good Clinical Practice (EFGCP), an organization created in 1993 to help develop and evaluate European health research. One of the EFGCP’s main purposes is to promote Good Clinical Practice (GCP) throughout Europe.

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September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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