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ARCC

An audit-ready 21 CFR Part 11 compliant hosting environment for all life science organizations.

Clinical

Unify clinical operations and manage digital content.

Regulatory

Streamline workflow at any stage of development including all regulatory submissions.

Complete Solutions

ARCC

Our Audit Ready Compliant Cloud infrastructure provides Life Sciences companies with the highest level of data integrity. We manage the 21CFR Part 11 validated infrastructure so you can focus on your core business needs.

RegDoc
RegDocs365

Tailored for Life Sciences companies, RegDocs365 is a fully compliant document management solution that serves as a third-party repository.

AI
Artificial Intelligence for Life Science

Going beyond accelerating research, Court Square Group’s AI also helps Life Sciences companies improve business decision-making, optimize innovation, and improve efficiencies.

CRO Support

We put a consistent framework together, essentially creating an extension of your IT support services, building and maintaining an FDA-compliant IT environment.

Quality Control
Qualification & Validation

We create validation protocols and documents on the GAMP guidelines, our validation experience, and the client’s method for validation.

Startup
Support for Start-ups

Our support offers a business-focused approach for start-ups as well as large international Life Science companies.

Spotlight

GxP compliance with AI
From Data Silos to GxP Compliance with AI

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Product Lifecycle Solutions

Regulatory

supports regulatory submissions through our eTMF

Clinical

CSG supports the compliant management of clinical data

M & A

See the M&A module in the Artificial Intelligence pages

Manufacturing

Our multi-model database allows you to run advanced analytics and Implement laboratory-based manufacturing systems, integrating those systems across other platforms.

Post-Market

Easily capture and analyze data from sites and patients for Real-World Evidence for HEOR), and regulatory approvals.

Clinical – Generate high-quality, reliable data clinical trial data with CRG’s compliant management solution.
Regulatory – With visibility into all your trial documentation, CRG supports regulatory submissions through EDMS, eCTD, and eTMF.
Manufacturing – Our multi-model database allows you to run advanced analytics and Implement laboratory-based manufacturing systems, integrating those systems across other platforms.
Post-Market – Easily capture and analyze data from sites and patients for Real-World Evidence for HEOR), and regulatory approvals.
M&A – AI technology and advanced search capabilities streamlines documentation review and organizes all digital content into one, FDA-approved repository.

Mary Beth Cicero, CEO and Co-Founder, 3Daughters

With RegDocs365 we’re able to track all of our development, project planning and regulatory information in a single secure collaborative environment – with confidence that our data is ready for regulatory submission.

Caroline Phares, Vice President, Healthcare and Life Sciences, Altair

Court Square Group’s Audit Ready Compliant Cloud (ARCC) is a critical component of Domino Cloud for Life Sciences. We wanted to ensure our Life Science customers would be protected from reguatory risk, in addition to quick onboarding and first-class support.