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CTCOMPLY.com Announces Help for Clinical Trial Compliance

July 13, 2009

CTCOMPLY.com is announcing a new product for clinical trial professionals "to stay on top of key compliance issues and streamline their operation."

It's described as an instant-answer interactive Web site from Thompson Publishing Group and AHC Media, putting Thompson's CT manuals, databases, news and analysis and other research tools in one online source. "The huge benefit of the online format is that we're able to keep the information continuously up-to-date," says says J.W. Schomisch, senior managing editor at Thompson.


"From keeping up with the latest compliance issues and sorting out the evolving conflict of interest guidelines, to data management, adverse effects, and preparing for an FDA inspection," CT COMPLY provides information and regulatory guidance on clinical trial issues, company officials say.

"CT managers can help ensure 100 percent compliance with changing state and federal regulations, ensure subject protection and meet privacy requirements, and avoid errors that could lead to fines, loss of funding or disapproval of data,” a company release states.

"CT professionals have been asking for this for years," says Schomisch, editor of the Guide to Good Clinical Practice. "Now CT managers can find advice to stay in full compliance, as well as advice to help save time and money and smoothly speed their trials. We've made it intuitive and easy to use with several ways to find what you're looking for."

The product includes complete, searchable online access to two industry-standard reference books -- Thompson's acclaimed Guide to Good Clinical Practice and AHC's Standard Operating Procedure for the IRB.

It also offers three quick-search databases, including FDA warning letters that show what clinical trial violations are being actively pursued. "The exclusive OHRP Determination letters database that shows exactly how to correct areas that may be out of compliance, and CT laws and regulations of all 50 states to help stay on top of state-specific requirements," company officials say.

A couple weeks ago TMC had the news that Medidata Solutions, a vendor of hosted clinical development, announced the Medidata Technology Partner Program, a new program designed to advance interoperability and data sharing across clinical trial technologies.

The program recognizes technology vendors, contract research organizations and other organizations that offer solutions that support data sharing with Medidata products, including the Medidata Rave platform, in order to streamline and enhance the end-to-end eClinical process.

David Sims is a contributing editor for ContactCenterSolutions. To read more of David’s articles, please visit his columnist page. He also blogs for ContactCenterSolutions here.

Edited by Patrick Barnard



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