invivodata delivered ‘up to the minute’ information on FDA and EMA perspectives and thought processes that are immensely helpful to me and my company as we integrate this knowledge into the strategic planning for our development programs.”
Pittsburgh, PA (PRWEB) April 23, 2012
invivodata, inc.®, the industry leader in reliable electronic solutions and strategic consulting services for successful patient-centered data collection in global clinical trials today announced the successful completion of its fifth annual conference in Naples, FL. The conference, PROficiency™ 2012: PROs and Beyond, provided biopharmaceutical researchers with current, relevant information on effectively using Clinical Outcome Assessments (COAs) in clinical development with focus on recent trends pertaining to regulators’ increasing emphasis on all patient centered data, including patient-, clinician-, and observer-reported outcomes (PRO, ClinRO, and ObsRO).
Three-time conference attendee Chris Prue, Vice President of Regulatory Affairs at Cerenis Therapeutics commented, “I thought the conference was excellent this year. invivodata delivered ‘up to the minute’ information on FDA and EMA perspectives and thought processes that are immensely helpful to me and my company as we integrate this knowledge into the strategic planning for our development programs.”
The conference enabled researchers from over 30 biopharmaceutical companies to advance their knowledge on the scientific, regulatory, and technical aspects of COA and electronic COA (eCOA) data collection. The 2-day conference began with a keynote address from Deborah Collyar, President of Patient Advocates in Clinical Research (PAIR), who demonstrated the benefits of involving patient advocacy and listening to the voice of the patient during clinical development. Attendees then participated in interactive assemblies and track sessions delivered by international biopharmaceutical researchers and leading experts who shared case studies of effective COA data collection in support of product labeling, reimbursement, and commercialization. The conference concluded with a mock regulatory panel that enabled attendees to witness what occurs ‘behind the scenes’ of researchers’ planning discussions and interactions with regulatory agencies during COA strategy development.
“We’re extremely pleased with the success of this year’s conference, which comes at a time of important change within the clinical development community,” said Doug Engfer, President and CEO of invivodata. “With FDA’s recent expansion of its PRO Guidance to all COAs many researchers are eager to determine the most effective path for including patient experience in their clinical development programs. It’s our hope that attendees came away from the conference with knowledge and practical information that will be used day-to-day in their clinical research.”
Select content from this year’s annual conference will be delivered in a series of 1-day regional conferences invivodata will host throughout the U.S. and Europe beginning September 2012. For information on dates, locations, and program agenda, please visit http://www.invivodata.com/resource-center/proficiency-educational-series/proficiency-regional-conferences/.
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 programs 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.