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MasterControl Clinical Quality (GCP) JumpStart

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Data Sheet 1 Data Sheet MasterControl GCP JumpStartâ„¢ 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 and compliance with research regulations. They 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 GCP JumpStartâ„¢ provides a complete document management solution for all of their clinical quality document needs. How Can MasterControl Help You? The MasterControl GCP JumpStartâ„¢ is a preconfigured document management tool for clinical quality research areas who wish to implement a solution to create, edit, revise, approve, access and train on good clinical practice (GCP) to support and ensure quality compliance of day-to-day operations in their clinical research activities. This configuration is designed for sponsors as well as contract research organizations (CROs) involved in every aspect of clinical research, from protocol design, site selection, patient enrollment, clinical monitoring, clinical auditing and trial closeout. HIPAA Informed Consent (IC) Investigational Product (IP) Administration Laboratory Research Documentation Audits, Visits, Monitoring IRBs Study Subjects Study Management Staff & Personnel MasterControl GCP JumpStart TM Document Management for Clinical Quality (SOPs, Policies, Specifications, etc.)

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