Business Details
31 Years
experience
FDA-Compliant IT Solutions for Life Sciences
Court Square Group is a leading managed services technology company dedicated to empowering life science organizations through innovative IT solutions. Since our founding in 1995, we have specialized in creating secure, validated environments that streamline compliance with FDA regulations like 21 CFR Part 11. Our team of experts provides technical support, compliance guidance, and audit readiness services tailored to the unique needs of life science companies, from startups to global enterprises. We offer a comprehensive suite of solutions including ARCC hosting, RegDocs365 document management, and AI-driven tools for clinical trials and regulatory submissions. Our focus on life science-specific challenges allows us to deliver enterprise-level consulting while maintaining the flexibility to adapt to evolving client needs.With decades of combined experience in pharmaceutical and biotech industries, we combine deep domain knowledge with cutting-edge technology to help clients move products from pre-clinical stages through manufacturing and market approval. Our commitment to innovation is demonstrated through partnerships with industry leaders and active participation in life science technology advancements. We prioritize client collaboration, ensuring our solutions integrate seamlessly with existing workflows while maintaining the highest standards of data integrity and security.
Services
RegDocs365
ARCC Hosting
AI for Life Science
Validation Services
IT Support
Pharmacovigilance
Clinical Data Management
Document Classification
M&A Support
Literature Reviews
Details
- Year established: 1995
Highlights and features
- We offer 30+ years of life science IT expertise with FDA-compliant solutions
- Our ARCC infrastructure provides audit-ready 21 CFR Part 11 compliance
- AI-powered tools automate clinical document classification and regulatory workflows
- We support both startups and global pharmaceutical companies with scalable solutions
- Our team includes former pharmaceutical industry professionals with deep domain knowledge
Associations and certifications
- 21 CFR Part 11
What people say
Critical component
Secure Clinical Collaboration
Forward thinking
Enterprise-level consulting
Deep knowledge
Services
RegDocs365
RegDocs365 is a 21 CFR Part 11-compliant document management solution designed specifically for life sciences. This platform centralizes regulatory content management while maintaining audit readiness. The system automates workflow processes at all development stages through commercialization, supporting discovery, clinical trials, and post-market requirements. Its AI-powered features include automatic document classification, metadata tagging, and intelligent search capabilities that enhance regulatory submission efficiency while ensuring compliance with FDA standards.
ARCC Hosting
Our Audit Ready Compliant Cloud (ARCC) provides life science companies with validated hosting infrastructure meeting 21 CFR Part 11 requirements. This solution ensures data integrity through secure storage, daily backups, and multi-application hosting capabilities. The environment maintains complete audit trails and version control while enabling real-time collaboration with multilevel security protections. ARCC's validated infrastructure allows clients to focus on core business operations while we handle regulatory compliance requirements for clinical, regulatory, and manufacturing data management.
AI for Life Science
Our AI solutions transform life science operations through automated document classification, intelligent search, and predictive analytics. The technology accelerates clinical trial processes by automatically categorizing trial documents, streamlining regulatory submissions, and enhancing literature review efficiency. AI-powered tools improve decision-making through data pattern recognition while maintaining compliance with regulatory standards. These solutions integrate seamlessly with existing systems to optimize research workflows and business operations across the drug development lifecycle.
Validation Services
We provide comprehensive validation services for life science IT systems following GAMP guidelines. Our experts develop validation protocols, execute testing procedures, and maintain documentation to ensure 21 CFR Part 11 compliance. Services cover installation qualification, operational qualification, and performance qualification testing. We support both new system implementation and ongoing maintenance of validated states through change control processes and periodic revalidation activities tailored to pharmaceutical industry requirements.
IT Support
Our life science-focused IT support services deliver fully managed solutions for regulated environments. We provide validation-ready infrastructure maintenance, application support, and compliance monitoring tailored to FDA-regulated operations. Our team creates consistent frameworks for IT environments that serve as extensions of client operations. Support includes protocol development, system qualification, and audit preparation services specifically designed for clinical, regulatory, and manufacturing technology systems in pharmaceutical organizations.
People
Keith Parent
Founder and CEO
Keith Parent founded Court Square Group in 1995 with extensive pharmaceutical industry experience. He leads the company's strategic direction in developing FDA-compliant IT solutions for life sciences.
Pamela O'Donnell
Controller
Pamela O'Donnell has served as Controller since 2010, managing financial operations and ensuring compliance with regulatory requirements for life science technology services.
Dan Leavitt
Director of Managed Services
Dan Leavitt leads managed services operations since 2018, focusing on delivering compliant IT solutions for life science organizations' clinical and regulatory needs.
Marco Marchettini
Director of Application Support
Marco Marchettini directs application support services since 2019, leveraging his pharmaceutical IT experience to maintain validated systems for life science clients.
John Chun
Director of Quality
John Chun serves as Quality Director since 2017, ensuring compliance with FDA regulations and providing expert validation consulting to life science clients.
Questions
What is 21 CFR Part 11 compliance?
21 CFR Part 11 is FDA regulation governing electronic records and signatures in life sciences. Our ARCC infrastructure ensures compliance through audit trails, access controls, and validated systems.
How does your AI help life science companies?
Our AI automates document classification, streamlines regulatory submissions, accelerates literature reviews, and improves clinical trial data analysis while maintaining compliance requirements.
What IT services do you offer for startups?
We provide scalable solutions including validated hosting, document management, and compliance support tailored to life science startups' budget and growth needs.
How do you handle merger and acquisition processes?
Our AI-powered RegDocs365 platform automates document organization, identifies missing files, and creates FDA-compliant repositories to accelerate M&A integration in life sciences.
What validation services do you provide?
We offer full validation lifecycle support including protocols, testing, documentation, and maintenance for 21 CFR Part 11-compliant systems in life science environments.
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