A clinical research organization (CRO) is a partner that will manage your clinical trial from the preclinical stage to Phase IV, directing critical areas from subject recruitment to data collection and regulatory compliance. Choosing the right CRO is an important decision that will set your trial up for success. The right CRO will help ease the burden of cost, meeting timelines, compliance, regulation, and overall trial management, as you navigate the unique complexities of your trial through each clinical phase.
To choose the right CRO, you need to do your research, ask questions, and weigh the answers to make an informed decision about whether a company is the right choice for your trial.
Here are seven questions and considerations to aid in your decision making.
Does the CRO have ample resources?
To make sure you’re selecting a partner that can meet the needs of your trial, you should identify several appropriate-sized CROs to consider. A smaller CRO may offer more personalized attention or specific expertise, while a larger CRO may have more broad experience or industry connections. Choose a CRO with enough resources that will allow them to prioritize your trial.
Does the CRO have relevant therapeutic area expertise?
The right CRO should have experience in your area of study or trial type. With valuable knowledge of challenges you may face, a CRO can aid your decision making and help you avoid pitfalls you may not foresee. To begin evaluating a CRO’s experience, ask about their past experience or review their case studies and whitepapers in research areas similar to yours.
Does the company have longevity?
There are several questions you should ask to determine whether a CRO is reputable: How many years of experience does the company have? Can you identify several trials they’ve conducted that have been successful? Can you talk to past or existing clients of theirs? Do they retain their employees?
Does the company’s personality and communication style work with yours?
A mismatch of business culture and style can result in miscommunication and, potentially, the mishandling of your trial, which can cause issues and delays. When evaluating a CRO, note how they handle communication. Are they responsive, agreeable, and adaptable? How do they handle feedback? Do you get the sense they’ll be able to meet your needs on a daily basis?
How does the CRO address change?
From protocol amendments to adaptive trial adjustments, navigating change is an important part of the clinical trial process. Issues arise and critical decision points will be reached. The right CRO will help you feel confident in your decision making when you arrive at a crossroad. Ask them how they handle change and have them provide examples of how they’ve navigated changes in the past.
How transparent is the CRO about cost?
A CRO should be open in disclosing their cost structure for the different service offerings you’ll be engaging them in. Find out how cost may change in the event of changes or delays.
How does the CRO approach project management?
Understanding how a CRO’s processes work will help you gauge if they’re the right fit for your trial. Do they have the right standard operating procedures to make sure timelines will be met? Will the CRO’s organizational structure complicate communication? Will their approach to project management make navigating your trial easier or more complicated?
For more questions to ask or aspects to consider, review this helpful NIH checklist.
