It All Started With A Dream and Two Decades Of Frustration

Trialynx is an AI-powered platform that accelerates clinical study development. We help you create complete, compliant study documents—protocols, IRB forms, and more—using an easy step-by-step process, saving time and reducing risk.

Unlike Word-based workflows, Trialynx programs institutional and sponsor templates directly into the platform. Researchers simply answer guided questions, and Trialynx auto-generates complete, compliant documents—eliminating version control issues, manual errors, and wasted time.

Trialynx supports all types of clinical research and stakeholders: academic research centers, CROs, sponsors, and independent medical writers. We offer flexible solutions tailored to your needs.

Trialynx can reduce study document development time by up to 80%. What previously took weeks or months can now be completed in hours—allowing your team to focus on execution.

Yes. Trialynx is designed with confidentiality and compliance at its core. We meet industry standards for security, data privacy, and regulatory compliance (including NIH, FDA, and ICH guidelines).

Most medical writing tools are just that—tools—designed to assist in drafting individual documents like protocols or consent forms. They often rely on copy-paste workflows, disconnected templates, and AI that can’t understand complex study relationships.

Trialynx takes an entirely different approach: it is a collaborative platform, powered by 500+ custom-trained AI agents and assistants, that enables your entire team to build a perfectly aligned study package. Trialynx allows sponsors, CROs, writers, statisticians, and subject matter experts to work side-by-side in real time—eliminating fragmented processes and endless email chains, taking document preparation from months to hours. Every document is automatically synchronized, giving your team confidence that your protocol, SAP, consent forms, and operational plans are always consistent and audit-ready.

Protocol development platforms typically focus on helping teams draft a single document: the protocol. Trialynx goes far beyond this. It is a collaborative, AI-augmented clinical trial workspace that transforms how entire study packages are created and managed. Trialynx builds your complete suite of study documents in perfect alignment—accelerating timelines, increasing compliance, and reducing manual workload.

Trialynx supports a wide range of critical clinical trial documents, including:

• Protocols
• Informed consents
• Investigator Brochures
• Statistical Analysis Plans (SAPs)
• Monitoring plans
• Consent Forms
• Data management plans
• Site forms
• Many others

Our document engine is built around global standards (ICH, NIH, GCP) and incorporates site- and sponsor-specific templates. Our easy-to-use, step-by-step platform helps your team create high-quality, compliant documents—fast.

Trialynx is built with security and compliance at its core. We implement a layered AI security architecture to protect your data at every stage:

• Data Isolation:Your data is not used to train AI models. Trialynx AI agents are pre-trained and do not learn from or incorporate your study data.
• Data isolation: Your data is processed and stored in secure, dedicated environments.
• Encryption: All data is encrypted both in transit (TLS 1.2 or higher) and at rest (AES-256).
• Access controls: Fine-grained enterprise-based, study-based, and role-based permissions control who can access what data and when.

Please check out our technology page to learn more.

No. Trialynx is designed for researchers, clinical teams, and medical writers—not programmers. Our platform uses a simple, step-by-step interface that guides you through answering targeted questions. Trialynx then auto-generates complete, aligned study documents—no advanced technical skills required. Whether you're an experienced clinical trial professional or a first-time investigator, Trialynx makes document creation faster and easier.