As a small to medium-sized company, the decision regarding how to outsource your clinical trial activities requires a fully informed discussion of the pros and cons. A completely in-sourced model is not practical for a small to medium-sized company, given the challenges with a small clinical organization.
For most companies, the need for appropriate staffing levels based on the phase of the study, having the required expertise based on the region of the clinical trial, and cost, are the main drivers for outsourcing clinical trial activities.
For small to medium-sized companies, a hybrid model using functional service providers rather than a full-service CRO provides efficiency in study execution. It also provides flexibility based on vendor expertise, without incurring the costs of a complete in-house model while maintaining quality and control over your study.
Why Using Full-Service CROs has its Pluses
Using a full-service CRO may seem to be a simple choice, but there are benefits and risks to consider. While having only one vendor contract to negotiate rather than multiple contracts can lead to earlier study start-up, project management, oversight, and other factors should be considered before making a decision.
Full-service CROs tout the expertise of their teams in your therapeutic area in order to gain your business. In actuality, the “A” teams are often reserved for larger companies who commit to many clinical trials leaving the small to medium-sized company with the “B” or “C” teams.
CRO staff turnover is a concern with any CRO, but larger, full-service CROs often serve as the training ground for entry level staff where quality among inexperienced personnel can vary considerably. I have found that having one project manager for all services can make oversight extremely time consuming on the sponsor company as it is challenging for one person to oversee all functions effectively. Additionally, it is challenging for one CRO to provide excellent expertise in all areas, usually one area of expertise is subordinate to another providing a trade-off scenario to the sponsor.
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The Merits of a Functional Service Provider Model
When working under a functional service provider model (FSP), a sponsor company can pick and choose among the best-in-class service providers to find the expertise needed for their therapeutic area. It is important to consider the cultural fit, experience, flexibility, and scalability when selecting a FSP partner. Therefore, conducting a thorough evaluation is key to finding the best fit for your company. There may be additional time needed to select the individual service providers and work through the contracting process with each FSP partner. However, having the right expertise in each area outweighs the additional time spent.
Specific areas that are frequently outsourced in a FSP model include regulatory consulting, clinical monitoring, data management, and statistical analysis allowing the sponsor to focus on project management and study oversight. For cost-containment purposes, medical device companies have moved many clinical trials from the U.S. to emerging markets such as India, China, Eastern Europe and Latin America due to the lower costs.
With the changing regulatory environment, many of the countries that previously did not have regulatory requirements for clinical trials have adopted new regulations. Having the right regulatory provider with the expertise to navigate this changing landscape, and locally-based teams with staff who speak the language, can save a lot of time during the study start-up phase.
A Big Decision with Long-Term Implications
Clinical monitoring in medical device studies is different than monitoring a pharmaceutical study. CROs with the right medical device experience can be challenging to find. Partnering with a CRO that is similarly sized to your company seems to work the best.
Many of the larger CROs cater to the more lucrative pharmaceutical companies as their studies are designed to enroll larger numbers of patients, and have longer follow-up requirements than most medical device studies. If the CRO is too large, they may not give a smaller company enough attention. A CRO that is too small may not be able to scale up and down with the staffing demands during the enrollment phase compared to the follow-up phase.
Selecting the EDC provider is a big decision that has long-term implications, so you must research each company carefully. When a company contracts directly with an EDC provider it allows for a single data infrastructure for all their future studies, rather than using the EDC utilized by each CRO that is under their control. Having a single database platform allows the study database to be leveraged for future studies; thereby, reducing programming costs and allowing data to be easily collected across trials for strategic planning and marketing purposes.
Opening up Clinical Research beyond the Standard RCT
Choosing a data management provider who has sufficient expertise in your EDC platform is one of the items that should be confirmed prior to selection. It is helpful if the data manager has programming expertise for your EDC platform. This may make implementing changes to the EDC more efficient than managing changes through your EDC provider, if the agreed contract allows outside programming. Confirmation that your EDC system can output the clinical data in the format consistent with most statistical analysis programs should also be considered prior to choosing your EDC provider.
The statistical analysis provider is almost always a function that is outsourced among small to medium-sized companies as there is not enough consistent work to justify having a statistician in-house. The recent adoption of adaptive trial designs has opened clinical research beyond the standard randomized control trial. Properly implemented adaptive study designs can reduce resource requirements, decrease time to study completion, and/or increase the chance of study success.
Optimizing Chances of Success
As a small to medium-sized company, funding for clinical trials can be limited so implementing these clinical study designs may provide cost-savings and decrease study timelines. Partnering with an experienced statistician who can determine if these adaptive trial methods can be applied to your studies is an area that specialized CROs can handle. With the FSP model, your company can tailor the right statistical provider for the specific trial design for each study.
In a small to medium-sized company, clinical trial results can significantly effect, negatively or positively, the long-term stability of the company. Given the importance of the clinical trial, contracts with any functional service provider should include transparent performance metrics within the given function. What’s more, the reporting of those metrics must be actionable. There are many areas to consider when selecting any service provider. Utilizing a functional service provider model rather than a full-service CRO model allows a company to select the best-in-class service providers thus optimizing their chances of success.