The Challenges:
- A biotechnology firm required dependable and budget-friendly data management and biostatistics support for their two Phase II schizophrenia trials
- Unfamiliar with utilizing Medidata Rave as an EDC and reluctant to conduct a trial run with the system
- Concerns about meeting GDPR standards due to the presence of European data
The Solutions:
- YouV was selected as the clinical data management partner for its proficiency, affordability, and rapid implementation plan
- YouV collaborated with the sponsor team to build confidence in using the new EDC platform and provided training to the team
- Expertise was leveraged to shorten build timelines and launch the studies in exactly 4 weeks.
- Experienced CNS team offered complete assistance throughout the study period, guaranteeing exceptional data cleaning and biostatistics support
The Results:
- Studies were made live in four weeks, resulting in more time for subject enrolment
- Data cleaning was of the highest quality, and the biostats team contributed to a quicker submission to the FDA
- YouV provided comprehensive support for Clinical Data Management and Biostatistics services throughout the studies
What Happy Sponsor Says?
I’d like to thank you and all YouV team members (DM, Stats, Programmers) for the excellent job you have done for our studies. You have always ensured great performance accompanied by high availability and flexibility. This has been highly appreciated.
