Monitoring of data and compliance throughout clinical trials require meticulous planning and careful execution. Contract research organizations (CRO) are crucial players in this process. However, the pharmaceutical clinical trial landscape is a rigorous, rapidly evolving territory, and even CRO's can occasionally experience a lapse with various FDA codes and compliance standards.
The team at Clindata Insight has over 20 years of CRO experience, working specifically with clinical trial documents, data and reports development. With complete understanding of the CRO/Pharma service agreement (including transactional, FSP, and Partnership models), our consultants have the ability to act as your temporary head of biometrics. Finding a capable liaison between your company and the CRO can be a trying task. We are here to make it one of ease.
Specific elements of our CRO oversight services include the following
• Governance structure development (KPI, communications plans)
• Clinical trial documents review (Protocols, SAP, CRF)
• Clinical trial data set review (SDTM, ADaM)
• TFL output review
• CDISC compliance check
• eCTD compliance check
• Submission documents review (e.g., CRF, SDRG, ADRG and Define.xml)
Contact us if you desire a seamless, smooth process to ensure you get everything you need from your CRO, and put your new therapeutic on the fast track to New Drug Application (NDA).