The challenges of greater regulatory scrutiny, complex logistics, downward cost pressure and increasingly rigorous data requirements are just a few of the reasons biotech and pharmaceutical companies look to outsource clinical trials. In a dynamic healthcare and regulatory environment, outsourcing increases flexibility by streamlining clinical trial management and enabling sponsors to concentrate their resources on their core capabilities.
Working with a contract research organization (CRO) has a variety of benefits to sponsors, including:
- Achieving efficiencies and economies of scale
- Managing perceived conflicts of interest
- Being able to leverage the intellectual capital and operational experience of a CRO in managing clinical sites and communicating with regulatory agencies.
But, how do you select the right CRO partner to support your success?
Having a well-defined strategy – a clear understanding of your goals, objectives and roles – from the start is critical to choosing the right CRO partner. Such clarity is important for ensuring that the CRO can match its services and expertise with your specific project needs. At the same time, based on their previous operational, regulatory and therapeutic area experience, the CRO can provide input that helps to refine project goals and objectives.
Here are some questions to ask when evaluating potential CRO partners, as well as tips on how to get the answers you need to make an informed decision:
- Does the CRO understand your specific needs, and are they able to show examples of how their organizational expertise and team experience can address your needs?
While it’s important to ask about organizational expertise, it may be even more important to ask about team experience. There is a high turnover rate in the CRO industry, and when employees leave a CRO, they may take their intellectual capital with them. Evaluating the core team members assigned to your project – the project manager, the clinical manager, the investigative site manager – and looking at their hands-on experience in the therapeutic area and in your target indication may give you a more accurate picture of how well the CRO can understand and address your specific needs. If the design of your clinical trials includes global sites, ask about the CRO’s experience in navigating the regulatory and ethical guidelines and requirements in foreign countries.
- Do they have in-house scientists and physicians who are able to think scientifically and creatively while keeping things simple?
In-house scientists and physicians are invaluable resources for helping sponsors design and refine clinical trial protocols that yield appropriately-powered data to meet study endpoints. Their subject matter expertise is also useful for designing and executing clinical trial feasibility studies, which help you to identify potential obstacles to clinical trial conduct and to develop processes and practices that mitigate risk and support successful study completion.
- Do they have experience managing and analyzing data in the therapeutic area of interest?
Data management – from case report form (CRF) development and database design to data cleaning and serious adverse event (SAE) handling – is a critical component of the clinical trial process which can vary significantly from project to project. Find out if the CRO has experience in your therapeutic area of interest, and what their data offerings are. Are you looking for a full-service solution, or a stand-alone or functionally-based biometrics service? Ask about their experience and expertise with specific database platforms. And, of course, be sure to learn about their processes for ensuring the quality, safety and confidentiality of your trial data.
- Do they have a track record of completing projects on time and on budget?
Clinical trial delays – especially delays in study start-up and enrollment – can be costly. When evaluating a CRO, ask about their track record and the processes and procedures they have in place to mitigate the risk of delays. Because of the uncertainties inherent in conducting clinical trials, budgets and schedules may need to be revised after project initiation. How does the CRO handle this? Understand how budgets and standard contract terms are structured, as well as how inflation and change orders may impact rates.
- Do they offer transparency into their process?
Transparency contributes to trust and team chemistry, which is among the most important factors for study success. You will be working closely with your CRO project team for an extended period of time, so you want to have a sense that they share your values, work ethic, and approach.
Our goal is to develop synergistic relationships with our clients – true partnerships in which we work alongside sponsors as colleagues, rather than as disjointed components of a vendor-client relationship. Let us know if you’d like to hear more, or want to set up time to discuss.