Translating Business Objectives into Technical Solutions

Court Square Group works with some of the largest pharmaceutical companies in the world. With extensive experience in the life sciences industry, we help companies research, develop, and bring new medicines to market.

Our Audit Ready Compliant Cloud (ARCC) offers the highest level of data integrity. We manage the 21CFR Part 11 validated infrastructure so you can focus on moving your ideas forward.

Unlike many traditional IT companies, we focus exclusively on your unique needs and requirements. We guide you through the early stages of discovery work to clinical trials, and through the FDA submission process.

Solutions for Sponsors

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  • RegDocs365 – an out-of-the-box, scalable, real-time collaboration solutions with 21 CFR Part 11 compliant tools: eSignature, eCTD, EDM & eTMF Reference Models, GxP audit ready and submission-ready PDF rendering.
  • 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.
  • Artificial Intelligence (AI) in Life Sciences – Court Square’s first-of-a-kind enterprise-level AI solutions will help augment your IT capabilities by understanding the needs and expectations of your sponsors. By understanding your unique requirements and differences, Court Square can provide an environment where the CRO has control and can still maintain the ease of use supporting multiple clients while maintaining the security and governance required in a 21 CFR Part 11 environment.
  • Quality & Validation – Assess existing validation processes or implement new validation solutions to meet your specific requirements.
Sponsors

Dive In

Cybersecurity in Distributed Clinical Trials
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