We speak with a number of sponsors who are seeking support from a contract research organization (CRO) to help them with their medical device clinical trial. Often these sponsors are also talking with larger CROs, because they feel they can meet their needs better, having the depth and expertise to help them with their global clinical trial.
There are often many reasons sponsors gravitate to larger CROs. It can be name recognition, strong therapeutic experience, a global footprint or many other factors. But bigger isn’t necessarily better.
Potential Challenges of Working with Large CROs
Our team has lost out on opportunities that eventually resurfaced, as the sponsor determines that they made a mistake in their selection process. They choose a large CRO only to find their main point of contact was inaccessible when they needed them. Their study team turned over (maybe more than once). They experienced delays. Or the organization allowed the trial to go significantly over budget. In some cases, IMARC Research has even been asked to clean up studies because the previous CRO did such a poor job during the study.
7 Qualities of The Right Size CRO
A CRO needs to be large enough and experienced enough to meet your needs, but not so large that you feel like just a number. Here are seven signs you’ve found a CRO that offers just the right combination of experience and personal attention.
1. Strong Management Support
As a sponsor, you should be assured that the CRO’s management team will always be involved in your study. They should be holding the CRO study team accountable and be ready to assist with the inevitable roadblocks that occur during the study. If there is an issue that needs to be discussed, such as project resourcing, budget constraints, changes to scope, etc., the management team should be aware of your project in order to quickly provide solutions. Their expertise and years of experience can also bring perspective to the study team and help guide significant compliance decisions.
2. Medical Device Focus
The industry has seen a number of large, pharmaceutical-based CROs enter the medical device market. This should be viewed with caution as there is a difference between drug and device studies. It is critical that the CRO of choice fully understands medical device regulations and their application through a demonstrated history of successful engagements.
3. Study Team Stability
High turnover rates have always been a point of concern with sponsors when considering a CRO. Look for a CRO with staff stability and inquire about how their retention rates compare with the industry average. Also spend time questioning the process that takes place when turnover does happen – who is responsible for bringing the new team member up to speed? How does the CRO maintain consistency?
4. Global Footprint
Dig into how the CRO will handle your global clinical needs. In IMARC’s case, we have aligned ourselves with strategic partners who share our values and work style. This continuity is important and can be critical with global studies. Some CROs have locations around the world, but do they operate from global quality systems? How do they align on work style and approach?
5. Therapeutic Expertise
Does the CRO have therapeutic expertise to handle your medical device study? Ask for examples of studies they have managed that are relevant to your device, whether it's for cardiovascular, orthopaedics, women's health, in vitro diagnostics applications or another area.
Does the CRO have the ability to ebb and flow on your projects? During the lifecycle of a project, there will be times when resourcing needs to be adjusted. Perhaps you need to start with a fully outsourced team until you can staff up your own resources. Is the CRO open to changing the resourcing requirements throughout the project? Conversely, if a sudden resignation leaves you without a key resource, can the CRO fill the gaps seamlessly? The CRO also needs to be able to react to sudden changes such as increasing efforts for short-notice datalocks, decreasing efforts during enrollment holds, etc.
7. Budget Management
Do you find that actual budgets often exceed what was proposed? Many CROs estimate very conservatively in order to win the project, knowing full well that once the study is underway, sponsors will not want to switch CROs, and they can easily negotiate a change order. Budgeting is a vital element to any clinical study, and it is important that the CRO provide an accurate estimate and contain costs throughout the study. We budget honestly, and we take pride in our ability to manage budgets and stay true to our budget estimates.
As a medium size CRO with global partnerships and specific expertise in medical device trials, IMARC Research is the right size to support your clinical study support needs. To learn more about our expertise and how we work with your team, take a moment to download this short guide.