Technology to Deliver Superior Clinical Trial Outcomes.
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
> commercialization
> preclinical research
> clinical research
> clinical trials management
> 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, 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.

Simplify the Complexities of a Compliant IT Environment
We can support your need to migrate data back and forth between sponsors and set up secure environments to help you manage multiple customers. We have more than two decades of experience designing and supporting compliant IT environments for life sciences companies. We keep up with the latest technologies and regulatory requirements allowing us to focus on helping you stay consistent in the services you provide.

Benefits for CROs
>> Improve efficiency and lower operating costs through consistent configurations.
>> 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-box SOPs, Quality, GxP Audit Ready.>> Reduce internal IT costs.
>> Built-in compliance.
>> Integration of many disparate systems.

Complete Solutions for CROs
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 also maintaining the security and governance required in a 21 CFR Part 11 environment.

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