Companies conducting clinical research studies are focused on establishing not only the safety and efficacy of their investigational products but also on the integrity and quality of the data they collect in compliance with research regulations. Clinical quality groups have a need for tools that will support them with the organizational processes and conditions under which clinical studies can be planned, performed, monitored, recorded, archived and reported.
The MasterControl Clinical Quality (GCP) JumpStart™ is a Web-based system that provides a complete document management solution for all of an organization’s clinical quality document needs.
Discover how MasterControl software can manage your processes, all while mitigating risk, improving speed-to-market, and generating ROI.
Get in-depth, comprehensive resources to guide development of your programs and processes.
Get insider information about the most relevant issues, and how to navigate and overcome the complexities of FDA regulations.
The MasterControl Clinical Quality (GCP) JumpStart provides out-of-the-box best practice configuration of document types and routes for collaboration, approval and review, electronic signatures, roles, version control, lifecycles, and PDF rendering specifically for GCP. It is an affordable solution for companies who want document control processes for the management of documents such as SOPs, work instructions and specifications documentation required by 21 CFR Part 312, Part 50 and Part 812.
The MasterControl Clinical Quality JumpStart configuration is based on the ICH GCP E6 (RI) Guideline. This guideline was developed by the appropriate ICH Expert working group and has been subject to consultation by the regulatory parties, in accordance with the ICH process. The objective of this ICH GCP guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
This configuration is designed for pharmaceutical, biologics and/or clinical research organization (CROs) looking to manage clinical quality documentation outlining procedures, methods, roles and responsibilities for all activities executed during clinical research studies, as well as procedures for pre- and post-study activities.