CLINICAL TRIAL MANAGEMENT SYSTEM - Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Clinical Research
 
Duration:
8 Weeks / 140 Hours
 
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Clinical Trial Management System

Introduction – CTMS in Modern Clinical Trials

Clinical Trial Management Systems (CTMS) are the backbone of global clinical operations, enabling sponsors, CROs, and sites to track milestones, manage sites, monitor resources, and ensure regulatory compliance. With increasing complexity of multinational trials, CTMS provides centralized oversight, integration with EDC/eTMF, and real-time dashboards for study teams.

The CTMS program prepares learners to understand, navigate, and apply CTMS functionalities in clinical trial operations. It blends regulatory and operational foundations with system workflows, giving professionals hands-on exposure to the tools that drive trial efficiency and inspection readiness.

Course Name :  Clinical Trial Management System
Course Code :  CTMS
Experience Level :  Beginner to Intermediate
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Medicine, Public Health, or Allied Health
Student Category :  Clinical Research Associates, Clinical Trial Assistants, Study Managers, Data Managers, Career Changers entering Clinical Research

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 8 weeks (140 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will:

  1. Understand the role of CTMS in clinical operations and sponsor/CRO oversight.
  2. Learn study setup, user roles, and protocol configuration in CTMS.
  3. Manage site feasibility, selection, and activation workflows.
  4. Track subject enrollment, visits, and protocol deviations.
  5. Monitor operational milestones (FPI, LPO, database lock) with dashboards.
  6. Plan CRA monitoring visits, generate trip reports, and track action items.
  7. Apply resource and budget management within CTMS (site payments, FMV).
  8. Ensure compliance with ICH-GCP, FDA, EMA, and Health Canada regulations.
  9. Integrate CTMS with EDC, eTMF, and Safety databases.
  10. Generate sponsor-level reports and inspection-ready documentation.
Who Should Take This Course
  1. Clinical Trial Assistants (CTAs) & Clinical Research Associates (CRAs)
  2. Clinical Study Managers (CSMs) managing global studies
  3. Site Coordinators expanding into system-based study tracking
  4. Clinical Data Managers learning operational workflows
  5. Career changers entering Clinical Research operations
Benefits & Outcomes
  1. Gain hands-on skills in managing clinical trial workflows within CTMS.
  2. Track milestones, enrollment, deviations, and payments in real-time.
  3. Build readiness for CRA, CTA, and CSM roles in pharma and CROs.
  4. Enhance employability in CTMS administration and study operations.
  5. Be prepared for regulatory audits and sponsor/CRO inspections.

    6. .

Career Pathways: After completing this course
  1. Clinical Trial Assistant (CTA)
  2. Clinical Research Associate (CRA)
  3. CTMS Specialist / Analyst
  4. Clinical Study Manager (CSM)
  5. Site Coordinator / Site Manager
  6. Clinical Project Coordinator

Curriculum & Modules

Modules

1. Introduction to CTMS and its role in clinical research

2. Study setup, protocol configuration, and user management

3. Site feasibility, selection, and activation workflows

4. Investigator database and communication logs

5. Subject enrollment, screening, and visit tracking

6. Operational milestones (FPI, LPI, LPO, DB lock)

7. CRA monitoring visit planning, scheduling & trip reports

8. Issue management, deviations, and CAPA tracking

9. Budget, grants, and site payment management

10. Compliance & inspection readiness (ICH-GCP, FDA, EMA, HC)

11. CTMS integration with eTMF, EDC (RAVE), and Safety databases

12. Reporting, dashboards, and sponsor-level oversight
Getting in Touch:

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.