Good Clinical Practice (GCP) Requirements Solution - GCPDocs JumpStart BrochureSource: MasterControl
For many years, the conducting of clinical trials relied on the integrity of the personnel involved in operating the trial. The introduction of good clinical practice (GCP) principles established an era of regulation previously unknown in the pharmaceutical and biotechnology industries.
The detailed documentation needed to meet GCP requirements could conceivably require organization and storage of thousands of pages. Additionally, a company filing a New Drug Application (NDA) must follow a set of guidelines which require a specific format. Failing to comply with the formatting directions means costly delays in time to market and profitability.
MasterControl GCPDocs JumpStart provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements. It is specifically preconfigured according to regulatory standards and industry best practices to help organize and control nonclinical, clinical, and regulatory documents to meet NDA document requirement needs for growing pharmaceutical and biotechnology companies. The software provides multiple simple routes for document collaboration, approval, and review. It’s an affordable solution for companies who want to automate their document control process.