The Challenges:
A pharmaceutical firm required a dependable and affordable Clinical Data Management (CDM) collaborator for their ongoing Phase III oncology study with 400+ sites. The sites experienced difficulties with data entry, causing delays in data cleaning, which impacted as a result. To resolve these issues, the sponsor sought a strong CDM partner who could swiftly address the study. The concern was integrating a new CDM partner during the study’s progress.
The Solutions:
YouV was chosen as the CDM partner due to its expertise, affordability, and efficient onboarding plan. The team closely collaborated with the sponsor to establish trust and tackle data cleaning issues. Our proficiency was utilized to conduct data cleaning and analysis, while our skilled Oncology team offered full support throughout the study to guarantee exceptional data cleaning and biostatistics assistance. Robust processes were established to guarantee accurate, comprehensive, and compliant data capture with regulatory standards.
The Results:
The quality of study data entry improved through frequent data cleaning and insights provided to the sponsor. Our services comprised of: quick identification and resolution of queries, data cleaning and reconciliation, access to real-time data and regular study updates, effective management of serious adverse event (SAE) reconciliation, combining local laboratory reference ranges with CRF data, and integrating, verifying, and reconciling external electronic data.
What Happy Sponsor Says?
The sponsor was impressed with the quick turnaround time and the ability of the YouV team to adjust to their needs in a short amount of time. They felt that they were now in a better position thanks to the support provided by the YouV team.