HumanTrue's CLARA is a protocol-powered AI that automates the interpretation of clinical trial protocols, streamlining the generation of regulatory-compliant documents and reducing the time from protocol completion to trial launch. By minimizing manual tasks and errors, CLARA enhances communication and engagement among stakeholders, leading to faster and more efficient clinical trials.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trial protocols are complex and unstructured documents, requiring extensive manual effort to interpret and extract key information. This leads to delays in trial start-up, increased risk of errors, and difficulties in communication among stakeholders.
Solution
HumanTrue's CLARA is an AI platform designed to automate the interpretation of clinical trial protocols, transforming them into actionable insights and streamlining the generation of regulatory-compliant documents. By semantically understanding study designs, CLARA automates tasks that traditionally require manual labor, reducing the time from protocol completion to trial launch. The platform delivers clear and accessible study details to all stakeholders, including study coordinators, sponsors, participants, IRBs, CROs, and study recruiters, fostering better engagement and recruitment. CLARA ensures document alignment, minimizes the risk of errors, and improves process flow by maintaining consistency across all outputs.
Target Audience
The primary target audience includes study coordinators, study sponsors, study participants, IRBs, CROs, and study recruiters involved in clinical trials.
Features
- AI-powered semantic understanding of clinical trial protocols, including activities, procedures, tests, and patient visits
- Configurable study reports generated automatically from uploaded PDFs, Word files, or NCT records
- Natural language querying of protocols, enabling users to ask questions and create summaries in any language
- Extraction of eligibility criteria as a searchable and filterable list
- Generation of informed consent forms, recruitment screeners, and other documents based on customizable templates
- Secure protocol chat for team collaboration
- Support for translation of generated content to any language, with certified human review
- HIPAA and SOC2 compliance, meeting standards set forth by EU and US regulatory bodies