Prelude

Prelude develops an electronic data capture (EDC) platform designed for complex clinical trials. The company serves research teams across more than 25 countries and dozens of therapeutic areas, offering a flexible, no-code eClinical technology suite backed by in-house human support. Prelude positions itself as suitable for organizations seeking enterprise-grade capabilities without the associated cost or complexity.

With over two decades of experience, Prelude has supported thousands of studies across academic institutions, biotechnology and pharmaceutical companies, medical device manufacturers, and animal health researchers. The platform is fully compliant with 21 CFR Part 11, ICH GCP, GDPR, and Annex 11.

Core Platform Capabilities

• EDC: A flexible, no-code platform for building, launching, and managing complex studies. Features include drag-and-drop form creation, eCRFs designed to mimic paper forms, support for advanced calculations, cohort management, and mid-study updates without downtime or data migrations.
• ePRO: A mobile application that allows trial participants to report outcomes from any location, with automated reminders to support engagement and keep data collection on track.
• eConsent: Digital informed consent forms with trackable workflows intended to simplify compliance and improve the participant experience.
• RTSM: A randomization and trial supply management system tailored to individual study protocols, designed to manage randomization and track trial supplies within a single system.

Services

• CRO Partnerships: Prelude works as an extension of CRO teams, providing in-house expert support, configurable technology, and real-time study visibility.
• Professional Services: Personalized support delivered by in-house Customer Success Engineers who are familiar with each individual study, including onboarding assistance and hands-on training.

Therapeutic Areas Supported

• Oncology: Tools for managing complex protocols and adaptive trial designs.
• Central Nervous System (CNS): Configurable technology for longer timelines, complex protocols, and imaging data stored directly within the EDC.
• Rare Disease: Flexible technology to support adaptive protocols and improve site and recruitment experience.
• Infectious Diseases: Tools designed for high-enrollment, fast-moving trials that require rapid launch.

Industries Served

• Academia: Investigator-led studies supported with intuitive tools, flexible pricing, and built-in compliance features.
• Animal Health: An end-to-end platform for companion and livestock research across various species and regulatory requirements.
• Biotech and Pharmaceuticals: Technology that scales for global and multi-site complex trials.
• Medical Technology and Devices: Built-in tools for device validation, regulatory tracking, and real-world evidence collection across trial phases.

Key Platform Features

• No-code study building with drag-and-drop forms and support for advanced calculations
• eCRFs that replicate the look and flow of paper forms to ease site adoption
• Adaptive study management allowing mid-study updates while maintaining data integrity
• Mobile ePRO application with automated participant reminders
• Dedicated product expert and in-house training for onboarding
• Compliance with 21 CFR Part 11, Annex 11, ICH GCP, and GDPR
• Cost-effective pricing relative to enterprise EDC alternatives

Prelude is used by consultants, sponsors, CROs, academic institutions, and site staff across a broad range of study types. User feedback highlights the platform's ease of use, customizability, real-time data access, and the responsiveness of the Prelude support team as notable characteristics.