Replies to post #273303 on Avid Bioservices Inc (CDMO)

[biopharm]

CJ, thanks for all your posts and it seems that many academics/research institutions that are collaborating with Peregrine seem to have "CTRR"

SCRI implements CTRR
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125366709

Interesting, though I'm looking for some confirmation that the FDA is REQUIRING these updates and if not, maybe Peregrine should require whomever collaborates to adhere/upgrade how trial updates are reported such as with CTRR... and possibly, the FDA required such a system after all the "errors" that have occurred in trials.

“VCU will partner with Virtify to help automate the clinical trial disclosure process to fulfill its regulatory requirements,” said Dr. Francis L. Macrina, Vice President for Research. “We anticipate that Virtify’s CTRR will significantly reduce the time and effort required to register and publish clinical trial information to clinicaltrials.gov.

Virtify announces Clinical Trial Disclosure Solution agreement with Virginia Commonwealth University

Lexington, MA, May 29, 2014 –Virtify, Inc., the market leader in Structured Content Management software solutions, today announced Virginia Commonwealth University (VCU) has signed an enterprise-level contract for its Clinical Trial Registration & Results (CTRR) disclosure software. Virtify announced the Program for the Academic/Research marketplace through its partnership with Forte Research Systems, Inc. VCU will become part of a working group of academic/research institutions that will provide product feedback and utilize Virtify’s CTRR offering to fulfill their regulatory obligations by disclosing their clinical trial information to the National Institute of Health’s clinicaltrials.gov system. The system will be implemented by the Office of Research under the leadership of VCU’s Chief Research Information Officer, Dr. David Fenstermacher.

The old paradigm for managing disclosure throughout the clinical trial process has changed. Many organizations, including those at academic and research organizations, manage clinical trial disclosure manually. Due to the large number of disparate, investigator-driven studies at these institutions, coupled with constant updates to these studies and compliance challenges with increasing complex disclosure requirements, using these manual processes has become cumbersome and often error-prone.

“VCU will partner with Virtify to help automate the clinical trial disclosure process to fulfill its regulatory requirements,” said Dr. Francis L. Macrina, Vice President for Research. “We anticipate that Virtify’s CTRR will significantly reduce the time and effort required to register and publish clinical trial information to clinicaltrials.gov.

Virtify’s CTRR software helps streamline and automate the mandatory registration and results disclosure postings to the clinicaltrials.gov website and to other registries. The software also has the ability to provide a compliance view across all studies at an institution, allowing for better reporting and proactive compliance. Virtify has extensive experience supporting life science clients in managing complex clinical trial disclosure and regulatory compliance. Virtify’s CTRR software, combined with Forte Research System’s OnCore CTMS, will offer academic/research institutions the most complete overall solution for managing compliance with regulatory reporting requirements.

"We are very pleased to welcome Virginia Commonwealth University as a client. The CTRR system will not only help improve compliance but will support the disclosure requirements for publishing to medical journals. The ability of the Virtify and Forte systems to communicate means that duplicate data entry will be eliminated and will enable VCU to have a robust and seamless clinical trial disclosure process," said Satish Tadikonda, President and CEO of Virtify, Inc.

http://www.virtify.com/news-events/press-releases/virtify-announces-clinical-trial-disclosure-solution-agreement-with-virginia-commonwealth-university/