Clinical Trial Management System (CTMS) Capability Self-Assessment Questionnaire for Biotech Companies

Biotech companies conducting clinical trials need a robust Clinical Trial Management System (CTMS) to streamline operations, ensure compliance, and enhance efficiency. The CTMS Capability Self-Assessment Questionnaire is designed to help biotech firms evaluate their current CTMS capabilities, identify gaps, and determine areas for improvement.

This questionnaire covers key aspects such as:
✅ Study Planning & Budgeting – Assessing trial setup, financial tracking, and forecasting.
✅ Site & Investigator Management – Evaluating site selection, activation, and monitoring capabilities.
✅ Regulatory Compliance & eTMF Integration – Ensuring adherence to GCP, FDA, and EMA regulations.
✅ Monitoring & Risk Management – Measuring oversight effectiveness and centralized monitoring.
✅ Data Integration & Reporting – Reviewing interoperability with EDC, eTMF, and analytics tools.

By completing this self-assessment, biotech companies can gain insights into their CTMS readiness and make informed decisions on technology investments to optimize clinical trial execution.