Glossary Term
Clinical Trial Management System (CTMS)
Definition
A Clinical Trial Management System (CTMS) is a software platform designed to streamline the planning, tracking, and management of clinical trials. It centralizes data and workflows related to trial operations, including site selection, patient enrollment, compliance tracking, financial management, and reporting, ensuring efficiency and regulatory compliance.
Relevance to the MedTech Industry
CTMS enhances the efficiency and transparency of clinical trials by automating and centralizing critical processes. It enables MedTech companies and Clinical Research Organizations (CROs) to manage complex trials effectively, ensuring compliance with Good Clinical Practice (GCP) standards and regulatory requirements.
Additional Information & Related Terms
Good Clinical Practice (GCP) Provides standards for clinical trial conduct that CTMS is designed to support.
Electronic Data Capture (EDC) A complementary system often integrated with CTMS for data collection.
Post-Market Clinical Follow-Up (PMCF) Monitored and managed using CTMS in post-market phases.
Regulatory Compliance CTMS plays a critical role in ensuring trials meet global regulatory standards.