Writing an RFP for a Modern CTMS Solution: A Step-by-Step Guide

Before writing an RFP, think about your organization’s priorities. Start by identifying the limitations of your current system and the goals you hope to achieve with a new CTMS. Insights from a SWOT analysis can act as a useful guide in the pre-writing process.

For instance, if your legacy CTMS has limited reporting capabilities, you may prioritize advanced reporting tools. If regulatory compliance has been a challenge, you’ll request detailed information on how vendors meet industry standards. Other factors to consider include system scalability, integration with existing tools, or user-friendliness.

Be specific when outlining your needs. Avoid vague language like “the system should support clinical trial workflows.” Instead, include measurable requirements, such as “the system must generate customizable reports and integrate with our existing electronic data capture system.” Setting these “SMART Goals” for your new CTMS allows potential vendors to write proposals that correspond to your prerequisites.

An effective RFP is detailed and leaves no room for ambiguity. Include the following sections to help vendors provide useful responses, tailored to your needs:

• Introduction: Briefly describe your organization, your clinical trial objectives, and the reasons for switching to a new CTMS. Include key details, such as the size of your team, the number of trials managed annually, and your anticipated timeline for implementation.
• Organization Needs: Clarify your team’s goals. Are you looking for a site-specific CTMS or an enterprise solution? Have you thought about future expansion and will you need that flexibility? The answers to these questions will help you immediately exclude unsuitable proposals.
• Scope of Work: Clearly define what the CTMS must do. Break this into categories like data management, training, usability, security, compliance, and vendor support. Include specific “frequently encountered scenarios,” such as managing site monitoring visits and handling regulatory updates. 
• Technical Requirements: List the technical features you need to see, as well as features that would be nice to have. These might include cloud hosting, data migration capabilities, and integration with other systems. For example, if you rely on electronic trial master file (eTMF) systems or financial platforms, add seamless integration to your RFP.
• Vendor Questionnaire: Include targeted questions to help you evaluate vendors. These can cover areas like data ownership, support services, and pricing transparency. For example, ask: “How frequently is the system updated, and how are updates deployed?” Or “What are your customer satisfaction rates, and how do you address customer feedback?”
• Evaluation Criteria: Create a criteria to determine how proposals will be evaluated. This not only helps vendors tailor their responses, but also gives your team clarity during the scoring process. Write the criteria based on your organization’s priorities. Let vendors know which capabilities will carry the most weight in your decision.
• Submission Details: Outline the format, deadline, and submission method for responses. Be clear about how vendors should structure their proposals, such as requiring an executive summary followed by detailed responses.

Once your RFP is ready, the next step is identifying vendors to whom you’ll submit it. This phase is as important as writing the RFP itself, as it determines the pool of solutions you’ll evaluate. 

Start with industry resources such as clinical research conferences, trade publications, and vendor directories specific to CTMS providers. Professional networks and peer recommendations can also be invaluable. 

Reach out to colleagues in clinical operations or other life sciences organizations to learn which CTMS providers they work with and their experiences. LinkedIn groups and forums focused on clinical trial professionals may also be good places to connect with others who’ve recently navigated a similar process.

Keep your key points and goals in mind throughout the process. Are you looking for a site-specific CTMS or an enterprise solution?  There are distinct differences that should be recognized to avoid including solutions not geared toward your needs

After listing possibilities, narrow the field by cross-referencing with their sites. A reputable CTMS vendor will list their offerings clearly and concisely on their site, so you’ll be able to see if you might be a fit. This will help you mitigate risk, cost, and time by eliminating unsuitable vendors and prioritizing more promising examples.

Once you’ve identified your vendor list, set a realistic timeline for the RFP process. Clearly state in your RFP when proposals are due and outline the next steps after submission. A typical RFP timeline might look like this:

1. RFP Release Date:After the release date, vendors should have at least two to four weeks to respond, depending on the complexity of your requirements.
2. Deadline for Vendor Questions: Allow a window for vendors to ask clarifying questions, usually one to two weeks after the RFP release. Provide answers to all vendors as quickly as possible upon receipt. 
3. Proposal Submission Deadline:Set a firm deadline and specify the format and method for submission (e.g., PDF emailed to a dedicated address or uploaded to a secure portal).
4. Evaluation and Selection:Let vendors know when you anticipate reviewing submissions and scheduling demonstrations or follow-up meetings. This phase usually takes two to three weeks, depending on the number of proposals received.
5. Conclusion and Contract: Create a timeline for how soon after selection you’d like to agree on a contract and start implementation—and when you’d like your new CTMS to be up and running. 

Communicate these timelines upfront, in your introductory messages, to give vendors a clear understanding of your expectations. This will not only help them prepare detailed responses but also give your team a framework for staying on track.

While drafting an RFP, finding vendors, sending it out, and waiting for proposals might seem complicated, it’s a structured, fair process. Stay tuned for our next installment of this series, where we’ll walk you through evaluating the proposals you receive. 

The BSI CTMS is top of the line and we have the track record to prove it. Our modern CTMS solutions cover all aspects of your clinical trials. 

BSI’s CTMS is the most innovative, function complete, and easy-to-use clinical trial management software on the market. It provides CTMS, eTMF, Study Startup and Trial Supply Management in one integrated, unified platform.

Standard interfaces (API) assure complete data oversight and easy integration with the external systems (e.g. EDC and eTMF) of your choice. The BSI CTMS is the central hub for all aspects of your clinical trials. It’s available as SaaS for ease of use, continuous improvement, and simplified infrastructure.

We’re modern, sleek, and designed with the user in mind for intuitive end-to-end clinical trial management. And the best part? We offer updates, upgrades, and scalability in-house with a full client support team for your legacy system migration and beyond. 

There’s never been a better time to embrace a better CTMS. Book a call today!