New Approach
Start in Our CTMS / eTMF On Demand and Pay Your License Later
ResearchManager has developed an on demand CTMS / eTMF specifically for start-up and mid-sized CROs. The onboarding and rollout can be phased, where you only pay for the assistance of our consultants to set up (part of) the CTMS. The benefits of this approach include:
Only Pay When the Clinical Study Starts
You don’t start paying your license until the trial actually begins. This means you can benefit from a CTMS / eTMF without a large upfront financial investment. CTMS / eTMF on demand allows you to use the system while you’re still waiting for sponsor funding.
Preparatory Work Can Be Done More Efficiently
1. Create a Fixed Document Structure
Set up a standardized folder structure for essential study documents (ESD) and create templates for frequently used forms and reports, as recommended by DIA. Also, define where the studies will take place — USA, Europe, or both? Ensure that the document structure meets FDA and/or EMA guidelines.
2. Define Roles for Access to Specific Information
Assign access rights for colleagues, sponsors, and ethics committees. All you need to do afterward is add a name and email address to give access to targeted information within the CTMS / eTMF.
3. Add Countries and Sites
This process includes identifying participating countries and selecting specific trial sites, keeping GDPR or other legal requirements in mind. Detailed information is recorded for each site: contact info, unique IDs, regulatory status, contractual details, and local requirements. Budget, monitoring plans, and language needs are also documented, forming the foundation for effective study coordination.
4. Define Workflows
Identify core processes such as approval workflows, document management, reporting adverse events, patient screening, communication flows among stakeholders, data entry, compliance checks, and exception handling. Each process can be detailed in the CTMS / eTMF — who performs which action, expected timelines, and automatic reminders if deadlines are missed.
Also Suitable for CROs with 1 to 3 Studies Annually
Are you a small or mid-sized CRO conducting up to 3 clinical trials per year? With our on demand pricing model, CROs only pay for the studies they actually conduct, instead of being tied to a package that’s too large for their needs.