Solutions for CROs

Contract Research Organizations (CROs) are essential in the research and development of new pharmaceuticals. CROs provide specific expertise to sponsors in biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.

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, applying the IT resources to integrate multiple systems is a distraction from CROs’ core business and scientific focus.

The efficient operation of a CRO and the delivery of quality services to sponsors, requires dedicated IT resources, expertise in FDA compliant IT environments, the skill to integrate disparate systems, proficiency in cybersecurity, and the ability to rapidly onboard new studies.

Court Square Group delivers the tools and expertise that enable CROs to provide sponsors with efficient processes and a positive engagement – improving your bottom line and strengthening client relationships.

Compliance is Complex

Building and maintaining an FDA compliant IT environment, integrating and validating disparate systems, and enabling secure collaboration is complex. Solutions that are not specifically designed for life sciences may not meet the requirements of FDA 21 CFR Part 11.

Solutions for CROs

  • Increase Revenue - Generate ongoing revenue stream with RegDocs365 - an out-of-the-box, scalable, real-time collaborative with 21 CFR Part 11 compliant tools: eSignature, eCTD, EDM & eTMF Reference Models, GxP audit ready. and submission-ready PDF rendering.

  • Reduce Costs - Improve efficiency and lower operating costs through consistent configurations.

  • Audit Ready Compliant Cloud™ - ARCC. A validated platform that unifies clinical operations and manages digital content and regulatory updates

  • Inspection Readiness. Conduct internal audits and reviews of your Quality Management System, policies/SOPs, qualification, computer system validation and relevant artifacts to ensure adequate oversight and controls are in place.

  • Quality & Validation. Assess existing validation process or implement new validation solutions to meet your specific requirements.

Benefits for CROs

A partnering with Court Square Group delivers benefits to CROs:

  • Focus on your science and your business

  • Faster onboarding of new studies

  • Incorporating new technology in a regulatory compliant fashion

  • Increased operational efficiency

  • Out-of-the-box SOPs, Quality, GxP Audit Ready,

  • Reduce internal IT costs

  • Built-in compliance

  • Integration of many disparate systems

Why Partner with Court Square Group

Court Square Group has the dedicated resources and 25+ years’ experience in designing and supporting compliant IT environments for life science companies. Technology changes at a rapidly and ongoing management of a compliant IT environment can be a burden on your resources. You can rely on Court Square to keep up with the latest technologies and regulatory requirements. Court Square Group can manage your IT so you can focus on your science and on your clients.

Court Square Group will go the extra mile. We will work with you till the right solution for you and your clients’ needs is in place.