This is the question that stumps many organizations when asked “who should run this clinical study? ". If your organization does not have a clinical department or has a department that is too small for the clinical trial under consideration, the answer is easy, you will need the services of a contract research organization (CRO). But if your organization could effectively execute the study as a full sponsor, there are still some benefits to utilizing a CRO and the pros and cons must be well-considered. This decision’s complexity is further compounded when multiple dynamics exist. For example, the clinical site is also your customer outside of the clinical trial, as may be the scenario in a specialized field of medical research. It is important that your clinical trial is executed to highest standards of quality and compliance, but it is also important that the finer details of the execution and interactions are supportive of the sponsoring company’s brand. This is harder to ensure when you outsource.
An experienced CRO can help you develop your study plan and execute it effectively based on its experience of working with different regulatory bodies and clinical sites. It can provide practical direction from experience with other organizations, quality systems and products. Further, it may be better equipped with research expertise, systems and equipment to allow for timely rollout and execution of the study.
If you decide that the best route is to outsource to a CRO, here are the things that are essential to mitigate some of the risk of outsourcing and ensure a good investment:
1- Clear negotiations:
If you do not know what services you are paying for, the time to ask is prior to executing the contract. Spend some time considering possible scenarios and running these scenarios through the proposed structure. If the study is delayed, how will this affect the overall costs of the trial? How much of the day-to-day management will be delegated back to your organization? If timelines are not met, how will this be reflected in the overall payment structure? There are no bad questions here. Every CRO has different terminology, methodology and assumptions, so walk through these details together to ensure that you are agreeing to the same plan before the trial starts.
2- Clear Role Definition:
Nothing is more frustrating and inefficient than when multiple people are doing the same tasks in parallel, unaware of the other’s efforts, or when all parties assume the task is being done and no one is doing it! Again, this can be avoided by walking through the details of the proposal with a specific focus on role definition at a fine level. What does a Clinical Research Associate do versus a Clinical Project Assistant? Come up with practical questions to get a true understanding of how each person will contribute. E.g., “If a clinical site has a product question for a clinical trial product, who will they contact first? ” “Who will be contacting the clinical sites for data clarifications? ” “How much involvement will your organization have in the initial roll out of the study to clinical sites? ”
This upfront investigation into the finer details of the process will add clarity and allow you to plan your resources appropriately with no surprises later.
3- Clinical Site’s Evaluation:
Once you qualify your clinical sites and have the best sites selected to collect data and contribute to your trial, the “qualification” roles will reverse. A site will begin to evaluate their experience in the study. You want them to feel that it has been a positive experience and a valuable use of their resources throughout the trial. This is especially true in a situation where there are limited sites to select from (e.g., specialty medicine). If they are an excellent site you will want them to participate in your studies time and again.
This is another area that is worthy of upfront reflection. Will the processes be clear and efficient from the site’s perspective? Will the medium for data collection be readily available and reliable for the clinical site to access? Is the person who is contacting the clinical site organized, respectful and reflective of your company’s brand? These are all a part of how the clinical site will “qualify” your organization and the value of the trials you bring to them. You will want to ensure that this experience represents your organization as professional, organized and polished.
A well-designed, well-executed trial can be one of the best investments a company can make. While you cannot control the outcomes of the study, you can control the process. By using a CRO, your organization can gain expert insight and benefit from vast research experience that may be beyond what exists in your organization. It is the responsibility of the sponsor to select a CRO that has the right level of experience and capability for your study. I believe that as an officer of your organization, it is also your responsibility to consider the effect of this selection on the overall brand of your company, which may last well beyond the discussion of the study results. This can only be accomplished by clear negotiation, role definition and thoughtful communication between the sponsor and CRO at the beginning of this journey. If this takes place, there will be no question residing in your mind when you are asked “to CRO or not to CRO? ".
BESPOKE Business Solutions provides clinical strategy, oversight and brand enhancing execution consulting for clinical projects of all scopes.
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