Study Conduct

PharmaSeek, PRCCI partner on Puerto Rico

Monday, May 2, 2016

PharmaSeek, an Investigative Site Network (ISN), is expanding the reach of its network by partnering with the Puerto Rico Consortium for Clinical Investigation (PRCCI). PRCCI is a newly established nonprofit government trust comprised of multiple clinical research sites throughout Puerto Rico. Through a collaborative network of investigators and the support of PharmaSeek, PRCCI hopes to promote and enhance clinical research and drug development in Puerto Rico.

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Clinical research in India: Despite setbacks, opportunity continues

Monday, May 2, 2016

India has 16% of the world’s population and accounts for 20% of the world’s disease burden, yet less than 1.4% of global clinical trials are conducted there. A series of blemishes in clinical research has shaken worldwide confidence—but experts say positive steps have been taken to bring hope for the future.

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MSOAC launches database for MS clinical trial data

Tuesday, April 26, 2016

A new database containing nearly 2500 patient records from the placebo arms of nine multiple sclerosis (MS) clinical trials is now available for research by qualified investigators. This is just one of the tools generated through the Multiple Sclerosis Outcome Assessments Consortium (MSOAC), a global effort launched by the National MS Society and Critical Path Institute (C-Path). MSOAC is striving to develop an outcomes measure that addresses the critical need for a more sensitive way to detect the benefit of potential treatments that slow or reverse progressive disability in people with MS.

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Bioclinica, ArisGlobal partner on pharmacovigilance model

Wednesday, April 20, 2016

Bioclinica, a specialty clinical trials technology and services provider, has announced the selection of ArisGlobal‘s Safety Cloud as the preferred safety platform for its pharmacovigilance services. Under this partnership, Bioclinica becomes the preferred partner for ArisGlobal in business process consulting and change management as sponsors implement or upgrade ARISg. Together the partnership brings a flexible delivery model that fits any organization regardless of size or case volume.

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Overseas FDA data integrity warnings: Combating a surge

Monday, April 18, 2016

A surge in the number of FDA-issued data integrity violations to overseas drug manufacturers is prompting concerns about ramifications and conversations about solutions.
A recent PricewaterhouseCoopers (PwC) report stated the number of warning letters by regulators has risen from five in 2010-2012 to 24 in 2013-2015—and all but one were issued to facilities located outside of the U.S. “That, to me, is just an astonishing increase,” said Alexander Gaffney, PwC Senior Manager, Life Sciences and New Entrants, Health Research Institute, and lead author of the report.

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Three Questions: Dr. Mohammed Siddique Tayob, Mzansi Ethical Research Centre

Monday, April 18, 2016

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Dr. Moham­med Siddique Tayob, CEO of the Mzansi Ethical Research Centre in Middelburg, South Africa, the winner of the Society for Clinical Research Sites’ 2015 Site Patient Recruitment Innovation Award (SPRIA), which recognizes sites that employ innovative patient recruitment strategies.

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