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Patient Database

Secure patient database creation and management for clinical trials, with QR code self-registration and GDPR compliance.

Solution by Datacapt
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Overview

Datacapt Patient Database is a software tool designed for clinical research teams to build, manage, and search a structured database of potential study participants. It is aimed at Phase I centers, contract research organizations (CROs), clinics, and hospital networks that need a reusable, long-term patient registry rather than a single-trial recruitment solution.

The platform allows teams to create customizable patient records, register patients via QR code or web link, and match candidates to studies using detailed filtering. It is designed to operate without IT involvement and supports GDPR and 21 CFR Part 11 compliance requirements.

Database Setup and Customization

  • Build fully customizable data fields to capture demographics, medical history, lifestyle factors, and other relevant attributes.
  • Create and manage any fields — medical, demographic, behavioral, or logistical — tailored to specific study or site needs.
  • Generate QR codes or web links to enable patient self-registration on any device, available 24/7.
  • Multilingual support and custom branding for patient-facing registration experiences.
  • Automated validation workflows to maintain data quality and compliance.

Patient Profile Management

  • Centralized patient profiles consolidating all data, associated studies, and visit history in one place.
  • Instant filtering and segmentation of the database by any custom attribute.
  • Track patient availability, interests, and contact preferences over time.
  • Maintain GDPR-compliant opt-in and opt-out tracking for each patient.

Long-Term Recruitment and Registry Use

  • Run pre-screening campaigns using targeted filtering across the patient database.
  • Use the database as a central registry for observational studies or post-marketing follow-up.
  • Supports building reusable patient pools that can serve multiple future trials rather than a single recruitment cycle.

Use Cases

  • Phase I centers building and maintaining healthy volunteer panels.
  • CROs managing condition-specific patient registries across consumer, personal care, and cosmetic research areas.
  • Clinics centralizing consented patients for future trial eligibility.
  • Hospital networks sharing structured patient pools across departments.

Compliance and Security

  • Patient data is handled with full consent tracking, access controls, and audit-ready logging.
  • Compliant with GDPR and 21 CFR Part 11 requirements.
  • Self-registration flows support optional validation steps and consent capture with automatic profile creation.

Datacapt Patient Database is part of a broader clinical trial management platform that also includes modules for patient recruitment, calendar and scheduling, patient compensations, EDC, ePRO, and eConsent. The platform is used by over 200 clients across more than 7,500 clinical trials.

Meta

Domain
Clinical Trial Management
Subdomain
Patient Recruitment & Trial Matching
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROMedical DevicesPharma
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
Lab Manager / Core Facility ManagerResearch ScientistClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxPGDPR