EDC

Prelude EDC is a web-based Electronic Data Capture platform designed for clinical research teams running complex trials. It targets sponsors, study builders, clinical research associates, site investigators, biostatisticians, and regulators who need a configurable, no-code system that supports the full study lifecycle — from initial build through database lock and long-term archiving.

The platform is built around the premise that flexibility and speed are not mutually exclusive. Prelude uses a no-code, drag-and-drop interface to allow study teams to design custom electronic Case Report Forms (eCRFs) and databases without programming experience, while also supporting advanced logic, cross-form calculations, and mid-study protocol updates without downtime or data migration.

Study Setup Capabilities

• Drag-and-drop eCRF builder supports any data entry field type with no coding required and includes a live preview mode for testing forms during construction.
• Cross-form edit checks and nested calculations can be applied to catch errors in real time before data is submitted.
• A reusable Form Library allows study builders to save and reuse form templates across multiple studies.
• Version control supports site-specific protocol customization and protocol amendments with minimal disruption.
• Mid-study updates can be made without causing system downtime or requiring study rebuilds.

Data Collection Features

• Intuitive eCRF navigation allows site users to move between forms in two clicks, with prefilled fields and automated edit checks to reduce transcription errors.
• An offline data entry app allows sites to collect data without internet access and sync once connectivity is restored.
• Study participants can enter data from any device, receive automated reminders, and upload photos through a patient-facing interface.
• Tailored user permissions and role-specific access controls ensure appropriate data visibility across all user types.

Data Review and Monitoring

• Centralized views of open queries, intuitive comments, and alerts support streamlined site collaboration and monitoring.
• Dashboards and pre-built reports allow tracking of enrollment, data status, and site performance directly within the EDC.
• Full-system audit trails log every action with a complete record of who performed what action and when.
• Data can be exported in full or filtered formats at any point during the study for further analysis.

Study Closeout and Archiving

• Streamlined final query resolution and data reconciliation tools support faster database lock.
• Submission-ready data exports are available in multiple formats including SAS XPT, XML, and HTML.
• Long-term secure archiving of study data and documents is supported for regulatory compliance and future reference.
• Compliant sign-off processes and auditable data trails are built into the platform to meet regulatory requirements.

Integrated Modules

• Randomization: Configurable with blocks, strata, and blinding to conform with any protocol.
• Medical Coding: Translates adverse events and concomitant medications into predefined codes and terms.
• Invoicing: Automates site payments based on fee schedules tied to study events.
• Trial Supply Management: Tracks, dispenses, and reconciles supplies with site-level visibility.
• Document Management: Supports storing, sharing, and accessing electronic binders online.
• Protocol Amendments: Facilitates mid-study updates and site-specific protocol version customization.
• Select Subject Data: Pulls subject-level fields into site forms for cross-level data entry and review.
• API: Enables integration with third-party systems and existing technology stacks.

Supported Therapeutic Areas and Industries

• Therapeutic areas include oncology, central nervous system (CNS) trials, rare disease, and infectious diseases, with tools adapted to the specific demands of each — such as imaging storage for CNS studies and adaptive protocol support for rare disease.
• Industries served include academia (investigator-led studies), animal health (companion and livestock research), biotech and pharmaceuticals (global and multi-site trials), and medical technology and devices (device validation and regulatory tracking).

Reported Performance Metrics

• 75% faster study build time
• 50% fewer transcription errors
• 50% less time spent collecting data
• 40% less time spent in quality assurance
• 30% shorter onboarding time

Prelude EDC is compliant with 21 CFR Part 11, Annex 11, ICH GCP, and GDPR, with built-in audit trails, secure eSignatures, and strict user access controls. The platform is natively integrated with a patient app and extensible via API, supporting connection to existing third-party systems across the clinical research technology stack.