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On Demand CTMS & eTMF for start-up and mid-sized CROs

CTMS & eTMF On Demand: The Game Changer for Start-Up and Mid-Sized CROs Start-up and mid-sized CROs face a dilemma. They want to implement a Clinical Trial Management System (CTMS)…

On Demand CTMS & eTMF for start-up and mid-sized CROs

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Posted:14 October 2024

CTMS & eTMF On Demand: The Game Changer for Start-Up and Mid-Sized CROs

Start-up and mid-sized CROs face a dilemma. They want to implement a Clinical Trial Management System (CTMS) & electronic Trial Master File (eTMF) for an upcoming clinical trial, but start-up and licensing costs can be a barrier when there’s no green light or funding from a sponsor to pay for the CTMS / eTMF. On the other hand, sponsors often see it as a plus when a CRO demonstrates that their documentation and processes are already in place. How can CROs break this cycle?

In this blog, we compare the traditional approach of start-up and mid-sized CROs (arranging CTMS / eTMF after the green light) with ResearchManager’s CTMS / eTMF on demand, where you only pay when the study starts.

Traditional Approach

No green light from the sponsor, no CTMS & eTMF
Waiting seems like a safe choice if the clinical trial’s funding isn’t yet confirmed. But is it really? Valuable time is lost, and opportunities to present your CRO more effectively to potential sponsors go unused.

A CTMS Also Benefits Communication with Sponsors
CTMS & eTMF help CROs streamline processes, record documentation, and improve communication among all involved parties — including sponsors.

Sponsors Focus on Trial Processes
Sponsors want assurance that a start-up or mid-sized CRO has the capacity and systems to manage a clinical trial effectively. A (largely) implemented CTMS / eTMF demonstrates that a CRO is serious about quality control. This makes a CRO more attractive to potential sponsors.

3-6 Month Time Loss After Sponsor ‘GO’
Filling a CTMS/eTMF framework can take months if all documentation and workflows still need to be developed. You can do most of this preparation in the CTMS / eTMF during the lead-up to the study, allowing for quicker study launch after sponsor approval. By setting up the CTMS / eTMF early, you avoid delays, inefficiencies, and wasted time.

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.

Conclusion

For small and mid-sized CROs, the CTMS / eTMF on demand pricing model appears more favorable than the traditional method of starting payments as soon as the license begins. On demand CTMS / eTMF allows start-up and mid-sized CROs to present themselves professionally to sponsors without the financial risks of full CTMS / eTMF implementation. The flexibility and scalability also make it attractive for CROs with a limited number of annual studies. Although a modest initial investment in consultancy is required, the benefits of efficiency and faster study start-up outweigh the costs once funding is secured.

Thierry Wetting

Thierry Wetting

International Sales Manager

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