For clinical trial sponsors, selecting the right Contract Research Organization (CRO) is a critical piece to the successful execution of a clinical trial. CROs can assist with a wide variety of important elements of the research process, including feasibility and study design, executing the protocol, managing data, and providing regulatory support. It’s important to choose a CRO that understands the services you are and are not looking for, and can work towards meeting your study objectives. In this blog, we’ll review some key considerations to take into account when bringing on a CRO, including CRO focus, services offered, and questions to ask.
Finding the right focus
First, consider the CRO's focus and expertise, and whether or not it aligns with your study. The CRO should have relevant experience in your therapeutic area of focus, as a thorough understanding of the disease and regulatory requirements will lead to better outcomes. In addition, the CRO should be well-versed in any additional particulars related to your trial or the drug being studied. For example, if your trial is a precision medicine one, choosing a CRO with genetics experience will be important.
Additionally, consider the CRO's geographic focus. If your study is being conducted in various locations, consider a CRO that has experience conducting multi-center trials in different regions. This can help ensure that the study is conducted effectively across all locations and that any differences in local practices or regulations are accounted for. A CRO with a global presence may be better equipped to handle cross-border studies and can provide valuable insights into the regulatory requirements and cultural considerations of different regions.
Choosing the right services
Second, consider the CRO’s service offerings. Different CROs specialise in different segments of the clinical trial process, so ensure that the one you select is expert at the specific services you need to execute your trial successfully. Some of the critical services to consider include:
- Clinical trial design and planning services, such as assessing feasibility and determining appropriate endpoints and sample size.
- Site selection and management services, including establishing site contracts and managing site performance through the trial.
- Clinical trial monitoring and oversight services to maintain the safety of participants and quality of data.
- Data management and biostatistics services to drive accurate and reliable data collection and analysis.
- Regulatory affairs and compliance services to navigate complex requirements and adherence to local laws and regulations.
- Clinical trial supply management services to handle supply chain logistics, including manufacturing, packaging, labelling, and distribution.
- Medical writing and documentation services to support regulatory submissions and clinical trial publications.
- Safety monitoring and pharmacovigilance services to ensure the safety of study participants and compliance with regulatory requirements.
- Quality assurance and auditing services to meet industry standards and best practices.
- Patient recruitment and retention services to drive trial enrollment and patient engagement.
Asking the right questions
When weighing your options in terms of CROs, don’t be shy about asking questions! A CRO should be able to answer each of your questions and provide examples where needed. This is also a great time to get a sense of the team’s communication style. Answers to key questions should steer you towards choosing a CRO that’s right for your study and provide reassurance. Depending on the support you are looking for, here are some important questions to ask:
- Can you provide examples of clinical trials you have conducted in our therapeutic area?
- What is your experience conducting multi-center trials?
- What specific services can you provide to support our trial, and can you customise your services to meet our needs?
- Can you provide references from previous clients?
- How do you ensure data accuracy and quality in your clinical trials?
- How do you manage the timeline and budget for a clinical trial?
- What is your approach to risk management, and how do you handle unforeseen issues during a trial?
- Can you provide regulatory support and guidance for our trial?
Selecting the right CRO is one of the most important steps to successfully executing a clinical trial. Consider a CRO with relevant experience in your therapeutic area that provides the specific services you need. Ask the right questions to ensure that the CRO can meet your study objectives and stay within your budget and timeline. Thoughtful CRO selection based on a comprehensive vetting process can streamline your trial process, reduce costs, and increase the chances of regulatory approval down the line.
At Sano, we work with sponsors and CROs to accelerate enrollment and simplify operations for precision medicine studies. To learn more about our platform for genetic testing, recruitment, and long-term engagement, get in touch.
