Best Practices for CTMS/eTMF Implementation: Choose the Track That Fits Your Organization

A Clinical Trial Management System (CTMS) and an Electronic Trial Master File (eTMF) are essential for conducting clinical research efficiently and in compliance with regulations. ResearchManager offers two implementation tracks to streamline the process. The Fast Track enables rapid, standardized implementation within five working days, while the Custom Track provides a fully tailored solution.

In this blog, we explore both implementation options to help you make an informed decision based on your organization’s structure and research needs. With years of experience successfully implementing systems for CROs, hospitals, and pharmaceutical companies, we ensure both tracks comply with all relevant laws and regulations while optimizing research processes.

Fast Track – Live in 5 Working Days

The Fast Track implementation is ideal for organizations needing a swift start. This approach is particularly popular among CROs operating on a per-study basis or organizations that want to establish a foundation before receiving final sponsor approval. This significantly accelerates the process after obtaining the green light.

The Fast Track Consists of 4 Steps:

1. Setting Up the Production Environment (5 Working Days)

• A region- and industry-specific template serves as the foundation for your organization’s CTMS/eTMF:

  – CROs: Pre-configured study monitoring and site management templates
  – Hospitals: Templates for local feasibility and ethics committee (METC) submissions
  – Pharmaceutical Companies: Templates tailored to different trial phases
  – Additional templates for regional compliance, including EU-GCP and FDA regulations

• Platform preparation, including timezone, date format, and currency settings

• Secure setup with a custom URL and SSL certification

2. Administrator Access & User Management

• Admin rights for managing users, modifying forms, and accessing system statistics

• Control over notification settings

3. Onboarding Session (30 Minutes)

• A guided walkthrough covering essential functionalities, such as creating studies, managing users, and configuring workflows

• Minor adjustments, such as setting up user accounts or notifications, made during the session

• Access to user manuals and online video training

4. Go-Live & Ongoing Optimization

• Immediate access to the live CTMS/eTMF

• Dedicated support team available for inquiries

• Organizations can make further customizations at their own pace, including adding forms, refining workflows, and generating reports

• ResearchManager consultants are available to assist with advanced configurations and integrations, such as linking reports or expanding into additional Clinical Data Management (CDM) solutions, including EDC, ePRO, RTSM, Visit Planning, and eConsent

IMPLEMENTATION OPTION 2

Custom Track – Tailored for Complex Processes

For organizations managing complex processes, such as hospitals, large pharmaceutical companies, or medtech organizations, the Custom Track is likely the best choice. This approach is designed for organizations with multiple departments, diverse study types, or integration requirements with other systems. The implementation timeline is approximately three months, depending on customization needs and testing speed.

The Custom Track Consists of 7 Steps:

1. Kick-Off Session

• Analysis of the current situation, including paper- and digital-based processes

• Identification of workflow inefficiencies and key stakeholders

• Defining primary system requirements

2. Customization of CTMS/eTMF

• Study-specific workflows

• User roles (e.g., Principal Investigator, Research Nurse, Monitor)

• Approval processes, reporting, and monitoring needs

3. Integrations and Data Migration

• Integration with systems such as EHR and PowerBI

• Single Sign-On (SSO) for seamless access

• Migration of existing studies and historical data

• Digitization of paper archives

4. Functional Design Development

• Comprehensive functional descriptions, including:

  • Custom workflows per study type and department

  • Tailored forms and templates

  • Role-based access and permissions

  • Custom reports, dashboards, and notifications

5. Specification and Requirement Documentation

• Technical specifications for system integrations

• Compliance requirements (GCP, FDA, GDPR)

• Security measures, audit trails, and data archiving policies

6. Implementation Plan & Timeline

• Detailed roadmap with milestones, responsibilities, and training/testing phases

• Go-live strategy and contingency planning

7. Testing, Iterations, and Deployment

• Thorough testing, including:

  • Workflow simulations with real-world scenarios

  • Form validation and security authorization tests

  • Performance assessments with realistic data volumes

  • Integration testing with linked systems

• Incorporation of user feedback before final deployment

• System setup and configuration as per approved design

• Final validation and approval for go-live

Post-Implementation Monitoring (3 Months)

• Ongoing performance monitoring and optimization

• Daily system checks, data integrity verification, and user activity tracking

• Backup validation and log file reviews

• Dedicated support team for immediate issue resolution

Implementation Track Checklist: Which Option Best Fits Your Organization?

Selecting the right implementation track is a strategic decision that impacts your entire organization. Key factors include research complexity, organization size, project timeline, and specific workflow requirements. Based on our experience, different organizations have distinct implementation needs. Below is a quick reference guide to help determine the best fit:

Fast Track is Ideal for Organizations That:

✔ Need a quick launch for a new study ✔ Want to establish a foundation that can be expanded later (post-sponsor approval) ✔ Prefer a flexible system for future customization

Common Fast Track Users:

• CROs working on a per-study basis

• Biotech companies conducting a few clinical studies per year

• Medical device firms with standalone studies

Custom Track is Ideal for Organizations That:

✔ Have multiple departments and stakeholders using the CTMS/eTMF ✔ Require various study types within a single system ✔ Need system integrations and advanced functionalities (SSO, HR, ePRO, etc.) ✔ Manage complex workflows that demand customized configurations ✔ Plan to migrate data from existing systems

Common Custom Track Users:

• Large academic hospitals

• International pharmaceutical companies

• Research institutions with cross-departmental studies

• Medical device companies managing complex study portfolios

• Biotech firms with extensive research programs

ResearchManager Implementation Success Stories

• Learn how Bravis Hospital transitioned from CastorSMS to ResearchManager using the Custom Track  » Case Bravis Hospital

• Discover how METC Erasmus MC replaced manual USB-based document sharing with ResearchManager’s RIMS system » Case METC Erasmus MC

Questions? Our Consultants Have the Answers

Would you like to discuss which CTMS/eTMF implementation track best fits your organization? Our consultants are happy to guide you through the possibilities.