The clinical development landscape is awash in technologies that automate everything from subject randomization (IVR/IWR) and subject study assessments and outcomes (EDC, ePRO) to trial master file (TMF) solutions.

If you are like many emerging small to mid-sized biotech and medical device companies looking at upgrading your technology, you know it’s time to move from your old Excel trackers or SharePoint systems to a new clinical trial management system (CTMS) that can grow with your organization.

But what are the right steps to choosing and implementing the CTMS that best meets your organization’s needs?

Here, we’ll lay out a path for your management and IT teams to ensure your CTMS selection and implementation process runs smoothly and efficiently from start to finish.

Sponsor Assessment

Whether you are a newly formed sponsor, organically growing out of pre-clinical development, or formed through a merger with another organization, you probably have this challenge: How do you scale your organization and efficiently leverage technology to provide clinical researchers better access to the information needed to make decisions about product development?

When we sit down with sponsors, we ask them to think about the following questions:

• What assets do you see developing over the next three to five years and beyond?
• What is your company’s strategy? Are you looking to take products from the pre-clinical to proof-of-concept stage, then sell or partner for the asset? Or, do you want to retain the rights through regulatory approval should the studies prove safe and effective?

We also look at the management team and their backgrounds to understand where each member previously worked, their former roles, and their areas of focus in the current organization.

• What is the company’s growth strategy? If a newly formed company is 20 people now with products about to enter Phase I, is the vision to grow to 200 people or more? Will this company develop products in house, use consultants, and outsource select activities to niche CROs? Or will they fully outsource study management to CROs while just providing oversight? Answering these questions helps us—and you—understand your organization’s phased approach to implementing solutions.
• What does YOUR management team believe is the best for the company? Many newly formed sponsors are 100% virtual, some are hybrid, and a few sponsors—at least small and mid-sized ones—fall in the brick and mortar category. This affects how much you will invest in technology.
• When I was just out of college and interviewing for my first job, I was coached to answer the question, “Where do you want to be in five years?” As the world changes, the management team needs to have a five- to ten-year view with goals set for the next two years. Situations change rapidly now, and sponsors need to pivot quickly and adapt. Just think of how much the pandemic changed the world in 2020!

Technology Roadmap

As our team evolves, we look at the organizational chart to determine what we have now versus where we want to be. Similarly, you need a technology roadmap layered over your clinical development plans that matches your organization’s goal and objectives. To build a strong technology roadmap, ask these questions:

• What resources do you have now?
• What are your organization's short-term needs?
• What are your three- to five-year needs?

Have your organization revisit these at least two times a year. Consider the 3 Rs: review, revise, and replace. You may decide to stay the course, revise your mid- to longer-term plans, or replace items on the technology roadmap based on where you are in your development lifecycle and how your new technology offerings are evolving.

Vendor Landscape

Now it's time to assess which providers offer the technology solutions you need. Here’s what you need to consider:

• Stability – Is the vendor financially stable? Will it be around in five years? You’re considering a long commitment to technology that is core to your operations, so you want to be sure your vendor will still be in business.
• Industry Expertise – Know whether the vendor has enough expertise with clients in clinical research. While you may have in-house experience to handle the technology, 99 percent of the time, your company will need a vendor that can provide solid technological consultation to meet your industry-specific needs.
• Regulatory Compliance – Companies that develop new software solutions such as a CTMS need to make sure their offerings comply with global regulatory requirements. While there are many regulations, 21 CFR Part 11 compliance is paramount. If a vendor tells you it is 21 CFR Part 11 “certified,” your company should be wary. There is no certification for 21 CFR Part 11 compliance. Rather, a vendor must demonstrate 21 CFR Part 11 compliance by mapping technology offerings and processes to Part 11 during qualifications audits.
• Quality Management Process – Developing and releasing a CTMS requires a vendor to have a standard Software Development Life Cycle (SDLC) process for each software release, including review and approval from quality assurance. Here are the key components of a good SDLC:

1. User requirement specifications
2. Functional and development specifications
3. A system to collect and track all features from development to unit testing and release
4. Validation plans and release requirements
5. Bug tracking

While many vendors do some or even all of the above, make sure the vendors you review can demonstrate they have an SDLC in place during the RFI or qualification process. Some still use inefficient paper systems to track requirements that have not been validated, which can be a risk. The vendor also should have a dedicated QA team to ensure software is developed and released in accordance with the SDLC, and that each software version meets all release criteria for deployment.

• Product Roadmap – About 10 years ago, clients would ask, “What is your five-year product roadmap?” Back then, companies did annual software releases at most. Today’s environment has changed, and both companies and their software vendors need to be more agile. A year of waiting for a new feature is too long. Instead of asking for a five-year roadmap, companies now ask for a 12- to 18-month one. If a vendor cannot provide a roadmap for this timeframe, then that vendor likely doesn't have a vision. If the vendor you’re considering does have a vision, make sure it aligns with your own company’s vision to avoid unfulfilled expectations and a bad vendor-client relationship.

The Final Countdown

Once you have narrowed down your list to a few potential CTMS vendors, it’s time to evaluate and select your organization’s best fit. This part of the process usually includes a final presentation by the few remaining vendors. Here’s what you want to consider at this stage:

• Who is on the bid defense team, and what experience do they have with successfully implementing a solution?
• Which vendor has the best rollout plan and has tailored it to your specific needs?
• Aside from the CTMS, does the vendor’s platform offer other modules that could be useful as you evolve your clinical trials in the future?
• Does the CTMS provider have an active user community? Does this community include clients similar to you who can share best practices for using the CTMS effectively?
• Does the vendor offer the CTMS type of training you think is the best fit for your company? Ask if the vendor offers live eClinical training. Does the vendor provide job aids or micro-learning (like YouTube) rather than a large user manual or a two-hour training video? The more modernized vendors should offer micro-learning training options.
• Did the final demonstration of the CTMS give you confidence that it can deliver 95 percent of your clinical trial requirements? Does the vendor have consultants to recommend best practices for leveraging the CTMS?

You will probably have many more questions specific to your company’s needs or about scoring methods, weighting, innovation, and more. There are many CTMS vendors out there, but this guide to CTMS evaluation and selection should give you and your company the tools you need to choose the best one.

For help with your CTMS strategy, or to learn more about Trial Interactive's CTMS, please contact us at info@trialinteractive.com.