Why invivodata
“What invivodata brought was the way of looking at the endpoints that we wanted to measure and how to do that with the methodology.”
Dr. Sara McKenzie
Sr. Program Manager, Sepracor, Inc.
Why invivodata > Scientific & Regulatory Expertise
Scientific & Regulatory Expertise
invivodata scientists are continually called upon to provide expert input on effective diary methods to the Food and Drug Administration (FDA) and other regulatory organizations. Our scientists deliver exceptional value to clinical trial sponsors, with distinctive abilities across a number of critical areas related to ePRO, including:
- Behavioral Science Expertise: The invivodata scientific team has more than 140 years of combined experience capturing and reporting PRO data to support more than 200 drug and medical device development programs worldwide. This expertise is embedded in the processes, libraries of reusable modules and services involved in configuring the right ePRO solution for your unique protocol.
- Regulatory Expertise: You can be confident that invivodata’s ePRO solution will meet all regulatory requirements and that invivodata is acutely aware of the evolving regulations pertaining to PRO data collection. invivodata adheres to and monitors the regulatory guidance, regulations, and best practices related to electronic PRO data capture including:
- 21 CFR Part 11
- HIPAA
- CSUCT/CSUCI
- GCP
- ePRO Expertise: For two decades, invivodata scientists have pioneered the development of scientific principles and innovative methods for the collection of ePRO data. From creating the first handheld electronic patient diary to supporting the first NDA to achieve FDA approval with electronically collected PRO data, invivodata continually has led the way with ground-breaking achievements to drive the ePRO industry forward.
The unique scientific and regulatory expertise delivered by invivodata scientists, and built into our solutions, provides sponsors with complete confidence in the quality, integrity and efficacy of the clinical trial data captured by our proven ePRO systems.
To learn more about how our scientific and regulatory expertise can benefit your clinical trial, contact us today