ProtocolScribe

IT Documentation Software

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ProtocolScribe eSource is a extensive, protocol-driven platform tailored for clinical research teams to streamline and automate source documentation, ensuring regulatory compliance and enhancing data integrity. Its main features include configurable, reusable components such as pre-validated visit worksheets, structured data fields, real-time validation checks, and audit-ready workflows designed around industry standards like 21 CFR Part 11, ICH-GCP E6(R3), HIPAA, and GDPR, which collectively reduce documentation burden, accelerate startup times, and improve protocol adherence; it addresses challenges faced by clinical trial professionals by simplifying data collection, minimizing errors, and ensuring audit readiness across diverse therapeutic areas, making it ideal for clinical research coordinators, trial managers, and regulatory teams seeking efficient, compliant, and standardized.

ProtocolScribe can be found in IT Documentation Software categories.

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ProtocolScribe Main Features

• Less Work
  Reusable components mean less paperwork and better stick to the protocol rules.
• Quick Setup
  You can start your source workflows in just a few days.
• Reusability
  Components can be reused across different protocols to save time and maintain consistency.
• Built for Sites
  The system supports site staff with tools designed around real-world clinical trial needs.
• Early Access Program
  ProtocolScribe eSource is inviting clinical research teams to join a waitlist for early access.
• Audit-Ready by Design
  The system is built to meet audit requirements with features like validation and E-signatures.
• Custom Visit Worksheets
  You can create clean, structured visit worksheets with validated fields, checks, and data validation.
• ProtocolScribe Platform
  The SaaS helps build compliant source workflows faster and easier, reducing documentation work and improving protocol use.
• Pre-Validated Components
  The Studio has ready-to-use modules like Informed Consent, Vitals, Lab Panel, PK Sampling, and ePRO/eCOA, all validated and ready to use.
• Protocol-Driven Workflows
  It creates workflows based on your specific protocol, making the process faster and more accurate.
• Supports Multiple Study Sites
  Workflows can be published and used across multiple research sites easily.
• Configurable for Different Therapies
  The system can be customized for different medical areas and meets safety standards like 21 CFR Part 11, ICH-GCP, HIPAA, and GDPR.

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