Contract Research Organizations (CROs) are vital in the research and development of new pharmaceuticals. CROs provide specific expertise to sponsors in many areas, including:
- biopharmaceutical development
- biologic assay development
- preclinical research
- clinical research
- clinical trials management
Oversight, transparency security, and compliance is critical in the strategic relationship between CROs, sponsors, and external partners. The challenge for many CROs is managing large volumes of scientific data, documentation, and regulatory content in an FDA 21 CFR Part 11-compliant environment. Additionally, solutions that are not specifically designed for life sciences may not meet these requirements and assigning IT resources to integrate multiple systems is a distraction from the CROs’ core business.
Court Square Group can put a consistent framework together, essentially, we are an extension of your IT support services—building and maintaining an FDA-compliant IT environment, integrating and validating disparate systems, and enabling secure collaboration.