Artificial Intelligence (AI) for Life Sciences

Artificial Intelligence (AI) technology is the digital technology with the greatest potential to improve R&D productivity in life sciences. AI-driven solutions are helping CROs and sponsors improve candidate selection for clinical trials, data integration, interpretation and pattern recognition including voice and video, and provide critical insights from the massive data sets – helping to get drugs and devices into market and improve people’s lives.

Court Square integrates with AI, Natural Language Processing (NLP) and Intelligent Automation solution providers to help biostatisticians and clinical data analysts with big data analysis and patient cohort selection utilizing genomic or proteomic data.

Beyond accelerating clinical research, AI is helping life science companies improve business decision-making, optimize innovation, improve efficiency across business operations through smarter, actionable insights in M&A, Regulatory, Quality, Supply Chain, and Manufacturing. Life science companies are implementing AI to reduce costs, avoid costly errors, and shorten time-to-market.

As a leading managed services technology company dedicated to empowering those who change lives, Court Square works with the foremost AI technology companies to provide platforms and point solutions that accelerate decision-making, reduce costs, and improve productivity.

Court Square’s RegDocs365 validated content repository serves as a third-party repository against which multiple AI solutions can share research, clinical and manufacturing data to be used independently for Artificial Intelligence applications to analyze company information across departments.

AI Solutions for Life Sciences

eTMF – eCTD Autoclassification – Save time by using AI to identify and assign meta-data, automatically classify and file any document to the appropriate locations while maintaining Human-in-the-loop (HITL) controls. Learn More.

Intelligent Search – Instant, secure, and affordable access to corporate content, regardless of where the data is stored and whether it is structured or unstructured. Learn More.

RFP Responses – Tap into your historical responses to generate up to 90% of a new RFP automatically — saving time, increasing consistency, and accelerating your path to new business. Learn More.

Streamline the Merger and Acquisition Process – Use AI to identify and sort through documents during the integration stage to streamline the M&A process. AI applies autoclassification and reference checking to identify missing files and organize all files into a predetermined model. Learn More.

AI and Statistical Computing Environment (SCE) – Domino Cloud for Life Sciences (DCLS), powered by Court Square Group’s Audit Ready Compliant Cloud (ARCC) is a fully managed, audit-ready SaaS solution. DCLS delivers an innovative AI and Statistical Computing Environment (SCE) featuring the traceability and governance required to support GxP processes. Learn More.

Generative AI – Efficiently harness and repurpose existing content scattered across organizational repositories to streamline content creation and innovation. Learn More.

Intelligent Application Decommissioning – Alleviate the burden and cost of maintaining legacy systems. Retain and leverage all the content within them in a secure yet accessible manner. Learn More.

Literature Reviews – Keep track of the body of published literature related to your products. Whether for regulatory filings, pharmacovigilance reporting, or monitoring off-label usage. Automatically scan, summarize, and assess every relevant study as it’s published without expanding your headcount. Learn More.

Rescue Trials – Streamline the rescue trial process by automatically classifying, cross-referencing, and integrating critical regulatory documents. Bring structure to disorder, reduce stress, and save valuable time and money. Learn More.

Getting Innovation to Patients Faster

The recent shortage of Clinical Research Associates (CRA) and Clinical Trial Associates (CTA) is driving the adoption of AI applications. Leveraging AI to augment limited clinical resources improves quality and shortens time to market.

AI enables CROs and sponsors to reallocate resources from time-consuming manual efforts to the quick review of output from AI programs that separate and classify documents. With AI the content locked within documents can be used to identify and categorize them utilizing the metadata from the various reference models.

Court Square is currently working with leading AI companies on both TMF autoclassification and EDM/eCTD autoclassification of documents based on the content of those documents. Our AI solutions analyze content locked in documents and reduce manual CRA efforts so you can maximize your resources.

RegDocs365

A regulated content and collaboration solution for Life Sciences.

ARCC

Validated & qualified hosting for Life Sciences.

AI For Life Science

Artificial Intelligence (AI) to improve Life Science business and clinical trials.

Qualification & Validation

Validation for protocols, processes and documentation.

IT Support

Fully Managed Life Science IT support services.

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Cybersecurity in Distributed Clinical Trials

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We are usually asked about

What AI solutions does Court Square Group offer for life sciences companies?

Court Square Group provides a suite of AI-powered solutions purpose-built for life sciences, including eTMF/eCTD auto-classification, intelligent search, generative AI for content creation, AI-assisted M&A document management, literature review automation, and rescue trial support. These tools integrate with validated environments like RegDocs365 and the Audit Ready Compliant Cloud (ARCC) to ensure compliance with GxP requirements. The solutions are designed to reduce manual effort, lower costs, and accelerate time-to-market for drugs and medical devices.

How does AI-powered auto-classification work for eTMF and eCTD documents?

AI auto-classification analyzes the content within regulatory documents — such as those in an electronic Trial Master File (eTMF) or eCTD submission — and automatically assigns metadata and files each document to the correct location within a reference model. Court Square Group’s approach maintains Human-in-the-Loop (HITL) controls, meaning AI handles the heavy lifting while human reviewers validate outputs. This reduces manual CRA effort significantly and improves consistency and accuracy across document management workflows.

What is RegDocs365 and how does it support AI applications in life sciences?

RegDocs365 is a validated content and collaboration repository built specifically for life sciences organizations. It functions as a centralized, third-party data store against which multiple AI applications can access research, clinical, and manufacturing data simultaneously. This architecture allows AI tools to analyze information across departments — regulatory, quality, supply chain — without duplicating data or compromising compliance.

Can AI help with clinical trial rescue and what does that process look like?

Yes — AI can significantly streamline the rescue trial process, which involves taking over a clinical trial that has stalled or encountered regulatory challenges. Court Square Group’s rescue trial solution automatically classifies, cross-references, and integrates critical regulatory documents from the inherited trial, bringing structure to what is often a disorganized document landscape. This reduces both the time and cost typically associated with getting a distressed trial back on track.

How is artificial intelligence being used in pharmaceutical R&D and clinical trials?

AI is being applied across the pharmaceutical R&D lifecycle to improve candidate selection, accelerate data analysis, support patient cohort identification using genomic and proteomic data, and automate document-intensive workflows. In clinical trials specifically, AI assists with tasks like document classification, reference checking, and 1572 form reporting — reducing reliance on scarce Clinical Research Associates (CRAs) and speeding up regulatory submissions. The result is faster, more cost-efficient development timelines.

What does "Human-in-the-Loop" (HITL) mean in the context of life science AI?

Human-in-the-Loop (HITL) is an AI design principle that keeps a qualified human reviewer in the decision-making process, rather than allowing AI to act fully autonomously. In regulated life sciences environments, HITL is critical because errors in document classification or data interpretation can have significant regulatory or patient safety consequences. AI handles high-volume, repetitive tasks at speed, while human experts review, validate, and approve the output before it is finalized.

How can life sciences companies use AI to streamline mergers and acquisitions (M&A)?

During life sciences M&A transactions, organizations must rapidly assess, transfer, and organize massive volumes of regulatory, clinical, and manufacturing documents. AI-driven solutions can automatically classify incoming documents, run reference checks to identify missing files, and organize everything into a predetermined structure — tasks that would take human teams weeks or months. This accelerates integration timelines, reduces due diligence risk, and ensures regulatory continuity post-acquisition.

What is a Statistical Computing Environment (SCE) and why does it matter for life sciences AI?

A Statistical Computing Environment (SCE) is a validated, controlled platform used by biostatisticians and data scientists to run analyses on clinical and research data in compliance with regulatory standards like GxP. In the context of AI, an SCE provides the governance, traceability, and audit-readiness required for AI-generated outputs to be trusted in regulatory submissions. Solutions like Domino Cloud for Life Sciences, hosted on a compliant cloud infrastructure, combine AI capabilities with the rigorous documentation standards that health authorities expect.