Business Details
Trusted IT Solutions for Life Science Innovation
At Court Square Group, we specialize in delivering tailored IT solutions for the life sciences industry. Our expertise lies in developing compliant infrastructure, AI-driven analytics, and document management systems designed to meet the unique demands of pharmaceutical, biotech, and clinical research organizations. With a focus on innovation and regulatory compliance, we provide services such as the Audit Ready Compliant Cloud (ARCC), RegDocs365 for document management, and AI-powered tools to streamline literature reviews and clinical data analysis.Our team works closely with clients to ensure seamless integration of technology, enabling them to accelerate research, reduce costs, and maintain adherence to FDA and GxP standards. By combining deep industry knowledge with cutting-edge technology, we empower life science companies to navigate complex challenges and drive meaningful advancements in healthcare.
Services
RegDocs365
ARCC Hosting
AI for Life Science
CRO Support
Pharmacovigilance
Document Management
Compliance as a Service
IT Support Services
Generative AI
Clinical Data Management
Highlights and features
- We specialize in FDA-compliant IT solutions for life sciences.
- Our AI streamlines data analysis for pharmaceutical research.
- We offer tailored support for CROs, start-ups, and sponsors.
- Our team has deep expertise in regulatory compliance frameworks.
- We provide validated infrastructure for clinical and regulatory workflows.
Services
RegDocs365
RegDocs365 is a fully compliant document management solution tailored for life sciences companies. It serves as a third-party repository for regulatory submissions, ensuring data integrity and audit readiness. The platform streamlines workflow at every stage of development, supporting eTMF, EDMS, and eCTD compliance while enabling secure collaboration and version control.
ARCC Hosting
Our Audit Ready Compliant Cloud (ARCC) provides a 21 CFR Part 11 validated infrastructure for life science organizations. This FDA-compliant hosting environment ensures data integrity and audit readiness, allowing clients to focus on core business needs without compromising regulatory standards or operational efficiency.
AI for Life Science
Court Square Groups AI solutions accelerate research and decision-making for life sciences companies. By automating literature reviews, clinical data analysis, and regulatory documentation, our AI tools reduce manual workloads, enhance accuracy, and enable faster insights while maintaining compliance with GxP, HIPAA, and GDPR standards.
CRO Support
We provide tailored IT support for contract research organizations (CROs), including validation protocols, FDA-compliant infrastructure, and workflow optimization. Our services align with GAMP guidelines to ensure seamless integration of systems, reduce validation time, and support large-scale clinical data management.
Pharmacovigilance
Our pharmacovigilance solutions leverage AI to automate adverse event reporting and document classification. Designed for compliance with regulatory requirements, this service streamlines safety data management, reduces manual effort, and ensures accurate, timely submissions for global pharmacovigilance programs.
People
Mary Beth Cicero
CEO and Co-Founder
Mary Beth Cicero co-founded Court Square Group with a focus on delivering compliant IT solutions for life sciences. She has led initiatives to develop RegDocs365 and ARCC, enabling clients to manage regulatory workflows efficiently while maintaining data integrity and audit readiness.
Caroline Phares
Vice President, Healthcare and Life Sciences
Caroline Phares oversees healthcare and life sciences strategy at Court Square Group. She has driven the integration of ARCC into Domino Cloud, ensuring clients receive secure, compliant infrastructure with rapid onboarding and dedicated support tailored to life science needs.
Questions
What IT solutions do you offer for life science companies?
We provide FDA-compliant hosting (ARCC), document management (RegDocs365), AI-driven analytics, and tailored IT support for clinical trials, pharmacovigilance, and regulatory submissions.
How does your AI technology benefit pharmaceutical research?
Our AI automates literature reviews, clinical data analysis, and document classification, reducing manual workloads and accelerating insights while maintaining compliance with regulatory standards.
Are your services compliant with FDA regulations?
Yes. Our infrastructure and solutions adhere to 21 CFR Part 11, GxP, and other regulatory frameworks to ensure audit readiness and data integrity for life science clients.
Do you support CROs and start-ups?
Yes. We offer tailored IT solutions for CROs, sponsors, and start-ups, including validation protocols, compliant workflows, and scalable infrastructure to meet evolving research needs.
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