Patient Reported Outcome analysis and deeper insight into FDA Final Guidance
Pittsburgh (Vocus) March 24, 2010 -- invivodata inc., the industry leader in patient reported outcomes (PRO) solutions and services for global clinical research, along with its scientific and regulatory consulting division,PRO Consulting, today announced a limited time, complimentary PRO Gap Analysis service to help pharmaceutical research teams better understand what they should be doing differently in light of the FDA's final Guidance on PROs in clinical research.
The 60-minute PRO Gap Analysis presents an opportunity for pharmaceutical and medical device researchers to speak with Senior PRO Scientists to assess what will be expected of them in their clinical research and PRO data from a regulatory standpoint. During these complimentary teleconferences, scientific and regulatory experts from PRO Consulting will also discuss what reasonable steps researchers can take to address any gaps and reduce overall risk in their programs related to patient reported outcomes.
Biopharmaceutical researchers can also participate in complimentary in-person PRO Gap Analysis meetings by attending PROficiency™ 2010- the 3rd annual Patient Reported Outcomes conference hosted by invivodata. This educational conference, which begins April 28 in Ft. Lauderdale, FL, brings together international professionals involved in the scientific, strategic, operational, and regulatory aspects of PROs in clinical research. In addition to receiving specific direction on complying with the final FDA Guidance, attendees will come away from the conference with the knowledge to identify, select, and develop PRO instruments that are “fit for purpose” for specific program objectives and to integrate ePRO seamlessly into their clinical operations. For additional information and to register for PROficiency 2010, please visit invivodata.com/proficiency2010.
"invivodata’s PRO Consulting scientists have long contributed to and tracked the regulations and guidance surrounding patient-reported data collection in clinical research," said Dr. Jean Paty, invivodata Co-founder and Vice President of Scientific, Quality, and Regulatory Affairs. "We are pleased to offer the PRO Gap Analysis and share our expertise with clinical researchers as they work to understand the new FDA Guidance and make key decisions about their PRO strategies in global clinical development programs."
To request a complimentary PRO Gap Analysis teleconference, please visit invivodata.com/pro-gap-analysis.
About invivodata inc.
invivodata combines behavioral science, information technology, and clinical research expertise to capture high quality clinical trial data directly from patients. invivodata’s electronic Patient Reported Outcomes (ePRO) solutions, which are based on over 20 years of research, deliver reliable patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague paper-based self-report data. invivodata’s solutions include comprehensive trial-support services that facilitate the collection of ePRO data, web-based access to study data and operational reports that give researchers and sponsors visibility into study progress, and scientific and regulatory consulting on the use of PRO data in a regulated environment. invivodata’s solution has been used in more than 275 clinical programs and is the industry-leading ePRO system in delivering primary efficacy data for FDA 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, Calif., USA. For more information visit invivodata.com.
About PRO Consulting
PRO Consulting, a division of invivodata, inc., provides consulting services to help clinical research teams effectively develop, execute, and document patient reported outcome (PRO) strategies to support their clinical research objectives. The PRO Consulting team has more than 140 years of cumulative experience in psychometrics, PRO study design, migrating and validating electronic solutions to collect PRO data, and has extensive experience working with the FDA and other regulatory bodies. For more information please visit patientreported.com.
Read the full story at http://www.prweb.com/releases/2010/03/prweb3772134.htm.
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