We’ve found that most researchers are pleasantly surprised to learn of the reasonable steps they can take to address any gaps and reduce risk in their programs related to COAs." Dr. Jean Paty, invivodata’s Chief Scientist, and Regulatory Officer
PITTSBURGH, PA (PRWEB) May 31, 2012
invivodata inc. ® the industry leader in reliable electronic solutions and strategic consulting services for successful Clinical Outcome Assessment (COA) data collection in global clinical research, today announced a series of upcoming industry conferences where invivodata’s scientists are offering a free 60-minute COA Gap Analysis for biopharmaceutical researchers who are facing questions about the use of COAs in their clinical research.
Recent statements issued by the U.S. Food and Drug Administration (FDA) indicate that researchers need to ensure all measurements and outcomes reflect what is actually happening with the patient (October 2011.) Specifically, instruments based upon a clinician’s evaluation of a patient (ClinROs), and measures taken by an observer (ObsROs), like a mother reporting about her child, are subject to the same requirements for reliability and validity as Patient Reported Outcomes (PROs), as delineated in the PRO Guidance (2010). In light of this, many biopharmaceutical researchers are turning to invivodata for support as they make key decisions about their COA strategies in global clinical development programs.
“We are pleased to continue offering this opportunity for researchers to assess what will be expected of them in their COA data strategies from a regulatory standpoint ,” said Dr. Jean Paty, invivodata’s Co-Founder, Chief Scientist, and Regulatory Officer. “We’ve conducted over 50 COA Gap Analyses with global biopharmaceutical companies to date and have found that most researchers are pleasantly surprised to learn of the reasonable steps they can take to address any gaps and reduce overall risk in their programs related to COAs.”
Senior invivodata scientists are available to meet with clinical researchers via teleconferences or at these key, upcoming conferences
- June 2-5, 2012; International Society of Pharmacoeconomics Research (ISPOR) Annual Meeting; Washington, DC
- June 24-26, 2012; Drug Information Association (DIA) Annual Meeting; Philadelphia, PA
For more information and to schedule a COA Gap Analysis, visit http://www.invivodata.com/complimentary-gap-analysis.
invivodata is the only fully-integrated Clinical Outcomes Assessments (COA) company delivering regulatory-proven strategic consulting and practical electronic solutions to biopharmaceutical companies who depend upon patient-centered research. From reliable and scientifically sound consulting that helps research teams effectively develop, execute, and document COA strategies to electronically collecting COA data in global clinical development programs, invivodata helps its customers strategically use patient, clinician, and observer reported outcomes data (PROs, ClinROs & ObsROs) to support labeling claims, enhance reimbursement strategies, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies. invivodata’s electronic solutions and strategic consulting services have been used in over 600 clinical projects and are built upon the industry-leading ePRO system in delivering primary efficacy data for global drug approvals. invivodata, inc. is a privately held company with global headquarters in Pittsburgh, PA., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, CA., USA. For more information, visit http://www.invivodata.com