Practical AI for Clinical Trials and Clinical Data Management

Real Artificial Intelligence for Clinical Trials

Datacapt AI embeds practical artificial intelligence into clinical trials to accelerate study design, data review, monitoring, audit readiness, query management, and multilingual execution, without compromising compliance.

Clinical trials generate complexity at every stage: protocol interpretation, eCRF design, data review, monitoring, audits, and multilingual execution. Datacapt Intellignece AI addresses these challenges where they actually occur inside your EDC and eClinical platform.

Study Design

AI Powered Study Design

Designing and maintaining eCRFs is one of the most time consuming and risk prone steps of a clinical study.

Up to 40% faster study configuration

Native CDISC CDASH-aligned item suggestions

Automatic eCRF structure generation from protocol content

Intelligent edit checks and validation rules based on clinical logic

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Patient and Site

AI Powered Patient and Site Review

Manual data review does not scale with modern trials. Datacapt AI continuously analyzes incoming data to help teams focus on what truly matters.

Generation of study, site, and patient reports based on your templates

Prioritized review queues for data managers and clinical teams

Accelerated data cleaning cycles

Automated study and site performance reports

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Monitoring & Queries

AI Driven Monitoring

Datacapt AI enhances centralized and risk based monitoring strategies by continuously assessing site and study level signals.

Intelligent prioritization of monitoring and query actions

AI-assisted query generation and management

Risk-based identification of sites and subjects requiring attention

Reduced back-and-forth with sites and faster query resolution

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From AI Assisted to AI Enabled Clinical Trials

Datacapt AI is not a single feature.
It is a foundation for continuously improving how clinical trials are designed, executed, and monitored.

Instant AI Translation

Seamlessly translate eCRFs, ePROs and study content. Apply updates in real time while preserving data integrity across all environments.

Autonomous Audit Trail Review

Monitor every change from build to export with AI that flags inconsistencies and ensures a pristine audit trail.

AI-Powered Reporting

Transform live study data into clear, actionable reports. Datacapt AI continuously aggregates and updates study, site, and patient-level reports.

AI-Driven Query Management

Break language barriers in global trials. Support sites in +125 languages, enabling instant communication and faster data resolution.

Human control and review always available

Efficiency meets expertise. All AI recommendations remain reviewable, editable, and fully validated by your teams.

Alignment compliance frameworks

Datacapt AI operates within validated and compliant infrastructures.Patient PII is protected, never exposed, and always handled in line with regulatory expectations.

Frequently asked questions

What is Datacapt AI and how is it used in clinical trials?

Datacapt AI is a set of artificial intelligence capabilities natively embedded in the Datacapt eClinical platform. It supports key clinical trial activities such as study design, data review, monitoring, query management, audit trail review, and translation. Datacapt AI assists users by identifying patterns, suggesting actions, and improving efficiency while keeping full human control and regulatory traceability.

Is Datacapt AI compliant with clinical regulations and data protection requirements?

Yes. Datacapt AI operates within the validated Datacapt environment and follows strict principles of traceability, transparency, and user control. All actions are logged, auditable, and aligned with clinical research compliance frameworks. AI outputs are explainable and can be reviewed at any time.

Does Datacapt AI replace data managers, CRAs, or QA teams?

No. Datacapt AI is designed to support clinical teams, not replace them. All AI generated suggestions, queries, and insights require human review and validation. Decision making, approvals, and accountability always remain with qualified clinical professionals, in line with regulatory expectations.

Can Datacapt AI be used in global and multilingual clinical studies?

Yes. Datacapt AI supports international studies by enabling instant translation of eCRFs, ePROs, queries, and study content. This helps ensure consistent terminology, faster communication with sites, and smoother execution across multiple countries and languages, while still allowing human review when required.

How does AI help with eCRF design and study setup?

Datacapt AI assists with eCRF design by suggesting form structures, fields, edit checks, and validations based on protocol content and therapeutic context. This helps reduce study build time, improve consistency.

Is AI used to generate or modify clinical data?

No. Datacapt AI does not generate or alter clinical data. It analyzes existing data and workflows to provide suggestions, alerts, and insights. All data entry, changes, and approvals remain under full human control and are captured in the audit trail, in accordance with clinical regulations.

How is Datacapt AI different from generic AI tools?

Datacapt AI is purpose-built for clinical trials and embedded directly into the Datacapt eClinical platform. Unlike generic AI tools, it is designed around clinical workflows, regulatory constraints, and data integrity requirements, ensuring that AI delivers operational value without compromising compliance or control.

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