Outsourcing all -or some- of your clinical trial activities to a contract research organization (CRO) can have large advantages. If you, as a sponsor, only have one or few internal employees dedicated to clinical activities, or have employees lacking the right experience to efficiently manage a complete clinical trial, a vendor can be helpful. But how do you select the one that fits your trial best?
As a clinical research associate, I worked with several sponsors and CROs and experienced that a good CRO/Sponsor fit is not for granted. Language and cultural barriers, company specific procedures and habits, available resources, company sizes, all kind of aspects can have influence on the Sponsor/CRO relationship. The Sponsor can prevent some of these difficulties by implementing a good CRO selection process. Let’s walk through this process step-by-step.
Approach the process of CRO selection in the same way you approach a job application process for a new employee. In some way you are adding ‘employees’ to your project by outsourcing, so the process is comparable. In a job description, you describe the responsibilities and tasks of the job, skills, and qualifications you require. You will find yourself doing the same for CRO selection.
The cooperation with your CRO will preferably be long-term or at least the duration of your trial. You both have to be willing to invest in the relationship, getting to know each other’s habits and procedures. Probably you prefer to communicate with one and the same contact person dedicated to your trial. High staff turnover rates are unfavorable. Dare to ask for turnover rates and previous experience. The reaction to these kinds of questions can already give you a gut feeling about the relationship and the willingness to invest.
Large CRO’s offer a broad range of activities and services, but do you need all? Some CRO’s are represented all over the world; is that necessary for your trial that includes 5 sites, located in 2 European countries? On the other hand, if it is your regulatory strategy to collect data in China, your CRO should be represented there as well. When you compare with the job application; you will not select underqualified employees but be selecting overqualified employees has disadvantages as well. The same applies for your CRO. Ask multiple CRO’s what services they offer and how they will deliver these. Review if their approach is in line with the duties, skills, and qualifications you have specified and with your company culture.
Closing the deal
Last but not least, the costs. Costs are an important criterion in CRO selection. Important for a sponsor is to be realistic. Consider the amount of work to be done objectively. If you do all activities internally it will require resources as well.
Too many services offered can make the project more expensive than necessary, too little qualifications and services offered might be visible at a low price. Of course, there are boundaries and internal management decisions that might play a role, especially in costs. From experience, I know that a poor Sponsor/CRO match will increase the costs throughout the project. For example, because the (large) CRO performs activities according to their SOPs that are not necessary for the specific, small project. Or the Sponsor expects certain activities from the CRO but these were not contracted, which requires a contract amendment.
If you and your selected CRO agree on tasks, duties, and costs you have to outline all in the contract. What is delegated to the CRO? Who is responsible for what? Include; confidentiality, milestones, costs etc. A contract is important, valuable and an absolute necessity, no doubt. However, in practice, if you and your CRO are not a good fit and difficulties arise, the contract will not save the day. Trust, teamwork, communication and collaboration are the keywords.
To summarize, there are many aspects that can support or weaken your trial. Some of these are hard to change, but a good CRO selection is a vital process. Not only for your current trial but also to build a long-term relationship, based on trust and companionship.
If outsourcing is or will become, a common activity within your organization it might be a good idea to describe the outsourcing process and the vendor contracting in a standard operating procedure (SOP). Use forms and checklist to guide and document the decision-making. Evaluate together with your CRO at the end of the project. Discuss what went well and which aspects can be improved for the future.
As with the job application, you will be most satisfied if your investment is long term, a good fit, of high quality and competitive as well.
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