AI in clinical trials: clarity, compliance and everyday value
In case you’re still in doubt, AI (Artificial Intelligence) is no longer a distant prospect for clinical research.
Global sponsors draft trial documents with language models, sites automate visit notes, and regulators publish guidance that specifically references machine-generated content. Yet many study teams still have one foot on the brake: Which platform is actually fit for purpose, and how do we ensure adhering to good practice?
To give practical answers, we compared three leading solutions, Clinials, ChatGPT (Enterprise/API) and Microsoft Copilot, in a new white-paper titled “Clinical-Grade AI: A Practical, Legal & Governance Comparison…”.
The paper goes deep into validation check-lists and legal clauses; this article offers the plain-language version.
Three Tools, Three Use-Cases
Platform | Best suited to | Key strength | Common starting point |
|---|---|---|---|
Clinials | Clinical trials Document simplification and content generation | Generates plain-language synopses, operational summaries and patient materials in multiple languages, complete with an audit trail. Built for regulated environments, custom-built for clinical trials. | Site-start-up packs, ethics submissions, patient-engagement assets |
ChatGPT Enterprise / API | Flexible, ad-hoc reasoning | Drafts and critiques protocols, summarizes large text sets, even produces code for data wrangling | Literature review, protocol drafting, internal Q&A bots |
Microsoft Copilot | Embedded productivity | Lives inside Word, Excel and Teams, turning meeting recordings and draft protocols into structured text that stays within the Microsoft 365 tenant | Investigator meeting notes, in-document editing, risk-based monitoring dashboards |
Practical Questions Study Teams Ask
How difficult is deployment?
• Clinials is a browser tool with an API; accounts are provisioned in minutes.
• Copilot appears as a button in Word or Teams once the license is activated.
• ChatGPT can be as simple as an Enterprise seat or as complex as a self‑hosted model behind a hospital firewall.
Will the data stay where it should?
Clinials workspaces are single‑tenant in AWS.
Copilot inherits Microsoft 365 data‑residency rules.
ChatGPT Enterprise retains data for 30 days unless you set a shorter window; API traffic is not used for model training but still needs a secure wrapper if you handle personal data.
Do we need extra validation?
The white‑paper includes information, checks, and recommendations that help turn the usual “computer‑system validation” into a straightforward task list.
Legal and Governance Snapshot
HIPAA and GDPR
Clinials offers a CDA (Confidentiality Agreement); Copilot is covered by Microsoft’s omnibus terms; ChatGPT currently does not, so personal health information must be redacted or routed through a proxy.
EU AI Act
Clinials does craft content based on a specific source (protocol) and has human-in-the-loop safeguards at every step;
Microsoft will shoulder duties for Copilot; embedding ChatGPT makes the sponsor a “provider” with the same obligations.
ICH E6(R3)
Log who did what, when, and why, and preserve records so they meet ALCOA+ requirements (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available).
What Early Adopters Are Seeing
Sponsors adopting a new standard for communicating to and empowering sites in a consistent way (one source of truth, readily available, for various usage and needs at every site, globally).
CROs assembling site‑start‑up packs 40 % faster.
Sites trimming plain‑language protocol and patient information drafting from two-three days to two hours.
These results point to three triggers that will move AI from pilot projects to everyday infrastructure:
1. Clear ROI stories that link AI use to faster enrolment and cleaner data.
2. Seamless integration into eTMF, EDC and the tools clinicians already trust.
3. Prescriptive governance - simple check‑lists that turn compliance from a concern into a routine tick‑box.
Next Steps
Whether you want faster patient materials, an efficient way to draft protocols, or simply a path through the regulatory maze, the tools are ready. The key is choosing the right fit, validating sensibly and building confidence across the team.
For detailed feature tables, regulatory citations and a ready‑to‑use validation checklist, view and download the full white‑paper here → Download
