invivodata Changes Organizational Structure to Meet Evolving Customer Needs

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COA Consulting Services to be Delivered through invivodata Consulting

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“Our COA consulting services have been widely adopted as researchers increasingly seek scientific and regulatory expertise in developing, executing, and justifying their COA strategies," Doug Engfer, President and CEO, invivodata

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 organizational changes which will better enable it to serve its biopharmaceutical and medical device clients. In response to regulators’ increasing emphasis on patient centered data, including patient-, clinician-, and observer-reported outcomes (PRO, ClinRO, and ObsRO), invivodata is integrating its consulting division – formerly PRO Consulting™ – into its portfolio of Clinical Outcome Assessment (COA) consulting services. The new service will be called invivodata Consulting and will both complement and integrate with the eSolutions and regulatory services provided by invivodata.

invivodata Consulting supports researchers as they design, select, implement, and defend to regulators and other key stakeholders all forms of COA data collection in the development of new medical products. Now that the U.S. FDA has made clear that clinical research must take into account all COAs, including PROs, ClinROs, and ObsROs, invivodata provides clinical researchers a full spectrum of high quality services that ensure all COA data meets the new, more stringent regulatory standards for accuracy and reliability. Depending on the research team’s specific needs, invivodata can deliver a fully-integrated set of COA services across the product lifecycle, or selected services to meet the team’s objective.

“Our COA consulting services have been widely adopted in the biopharmaceutical and medical device community, as researchers increasingly seek scientific and regulatory expertise in developing, executing, and justifying their COA strategies to regulators and other stakeholders,” said Doug Engfer, President and CEO of invivodata. “Offering these scientific and regulatory services as a component of our broad COA data capture solutions delivers more value to our clients and allows us to respond to all of their needs. Now our clients will interact with one organization, regardless of whether their needs center around critical pre-study consulting work, proven eSolutions for COA data capture in clinical trials or, as in many cases, both.”

To reflect this evolution, invivodata is launching a new corporate Website, where visitors can easily find information on current, global regulations pertaining to COA research, read successful COA data collection strategies and implementation case studies, and determine which invivodata eSolutions and/or consulting services will best help them meet their development, labeling, and commercialization goals. Website visitors can also view and download recent industry publications on a broad variety of topics pertaining to COA data collection at invivodata’s online COA Resource Center. Visit http://www.invivodata.com for more information.

About invivodata
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.

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Christine Tobin
invivodata (SBE)
412-390-3000 3502
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