Datacapt

Datacapt is a clinical data management and eClinical platform designed to support the full lifecycle of clinical trials and research studies. The platform serves a broad range of organisations including contract research organisations (CROs), medical device companies, biotech and pharmaceutical firms, academic research institutions, and consumer health companies. With over 200 clients worldwide, more than 7,500 clinical trials conducted, and deployments across 45+ countries, Datacapt provides an all-in-one environment for study setup, data collection, patient management, and trial oversight.

The platform is built to replace legacy systems with a more intuitive and flexible approach, supporting studies of varying scale — from small academic investigations to large multi-site trials involving up to 10,000 patients. Datacapt reports managing over 3 billion data points, maintaining 99.99% uptime, and serving more than 50,000 end users globally. Studies can be configured and launched with significantly reduced setup time, with the company citing a threefold improvement in speed across design, data collection, and reporting.

Clinical Data Management Modules

• EDC / eCRF: An electronic data capture tool that allows collection and management of trial data on any device. Designed to be user-friendly and powerful for building and managing electronic case report forms.
• ePRO – Survey: A module for building, sending, and collecting patient-reported outcomes electronically, replacing paper-based survey processes.
• eConsent – Signature: A digital informed consent workflow incorporating multimedia elements and designed to meet compliance requirements for modern clinical trials.
• Randomization: Automated, integrated randomization functionality to support unbiased subject allocation.
• Alerts and Automations: Workflow automation tools with real-time alerts to monitor trial progress and flag issues as they arise.
• Reports: Real-time reporting and customisable metrics dashboards to support data-driven decision-making throughout a study.
• Translation: Support for 85+ languages to facilitate global participant engagement.
• Document Upload: Centralised, secure document storage for all trial-related materials to support team collaboration.
• Televisit: Secure video visit functionality enabling remote patient engagement and decentralised trial conduct.

Clinical Operations Modules

• Recruitment: Tools for accelerating patient enrolment, including advanced pre-screening capabilities and real-time recruitment tracking with KPIs covering recruited, pending, and rejected patients.
• Scheduling: Automated visit scheduling with calendar synchronisation and reminder functionality for site operations.
• Patient Payments: A module for managing patient reimbursements and tracking payments within the clinical trial management system (CTMS).
• Patient Database: A configurable database for storing and managing patient characteristics, with advanced filtering to identify eligible participants based on study criteria.
• 1:1 and Bulk Messaging: Messaging tools for sending individual or campaign communications to patients worldwide.
• EDC Integration: Automatic linking of patients enrolled through the recruitment module to the EDC platform.

Compliance and Security

• Datacapt holds ISO 27001 certification and is designed to comply with GDPR, GCP, and 21 CFR Part 11 requirements.
• The platform is described as compliant by design, with regulatory compliance built into its workflows rather than added as an afterthought.
• The system is used by 75+ active patient registries worldwide, reflecting its suitability for long-term, regulated data management.
• Security and uptime are highlighted as core infrastructure commitments, with the platform reporting 99.99% availability.

Target Industries and Use Cases

• CROs: Scalable infrastructure supporting multi-site studies from small to large patient populations, with compliance built in.
• Medical Device: Support for clinical investigations, market approval processes, and high-quality data capture requirements.
• Biotech and Pharma: Coverage across all clinical trial phases with tools for resource optimisation and regulatory readiness.
• Academic Research: Simplified data collection workflows, secure storage, and tools for collaborative multi-institution studies.
• Consumer Health: Centralised data management, harmonised trial oversight, and real-time data access for consumer-focused studies.

Datacapt combines EDC and CTMS functionality within a single platform, enabling organisations to manage both data capture and operational trial management without switching between separate systems. Customers have noted the platform's ease of configuration, speed of deployment, and the responsiveness of the Datacapt team as factors in their adoption of the solution.