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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 andother 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 theteam’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 broadvariety of topics pertaining to COA data collection at invivodata’s online COA Resource Center. Visit
for more information.