Beyond Paper: Enhancing Clinical Validation with Arete Biosciences' EDC Solutions
Electronic Data Capture (EDC) refers to software databases used for clinical validation data collection and aggregation. Opting for an EDC database over traditional paper-based Case Report Forms (CRFs) can vastly improve the robustness and efficiency of your study documentation. In addition to reducing the paper footprint of your clinical trial, EDC facilitates real-time monitoring and review of data collected from various trial sites.
Arete Biosciences has a dedicated in-house data management team that is responsible for design, development, validation, and deployment of 21CFR Part 11 compliant electronic databases to manage your clinical validation studies. By collaborating with a capable CRO like Arete Biosciences, you gain the advantage of tailoring the EDC system to your study's specific needs while maintaining full control over the database.
A critical aspect of effective EDC design involves enabling the system to automate tasks and facilitate user interactions between study monitors and clinical site staff. Arete's data management team implements intelligent logic and edit checks to promptly identify and resolve errors in real-time, expediting the data validation process post-trial completion.
Here are the strategies Arete relies upon when building EDCs for our clients:
Database Workflow: During the design phase, Arete will work with you to plan out your study workflow and CRF data collection sequence. Meticulous upfront planning will ensure a smooth data entry experience for your clinical trial sites.
Annotated Paper CRFs: Arete will use CRFs approved within your Quality Management System to serve as the blueprint for the electronic format. CRFs will be annotated with data and logic checks, which will anticipate user needs and optimize usability.
Data Validation Plan: This plan will list and describe all the data logic checks configured in the EDC, and how they will be programmed and validated. A Data Validation Report will be written upon completion of validation activities to ensure compliance with security standards and demonstrate validation of the system’s functionality.
User Acceptance Testing (UAT): Arete will execute UAT protocols to thoroughly test logic and edit checks to verify system performance before deployment.
Compliance: EDC systems require regulatory compliance with 21 CFR Part 11, FDA’s guidance on electronic records. A thoughtfully designed EDC empowers Sponsors to submit data to the FDA confidently.
As the architect of your EDC, Arete plays a pivotal role in continuously improving and refining the database to support your clinical validation needs. Database changes can be swiftly implemented without reliance on external vendors with extended turnaround times and increased cost. The Arete data management team is dedicated to supporting you in enhancing the quality and success of your clinical validation studies through sound data management practices.
Visit Arete's Clinical, Quality & Regulatory page to see what our clients are saying about their experience working with us.
