What Is a CRO?
What is the difference between a CRO and a sponsor?
Although the sponsoring company may transfer the trial functions to a CRO, the sponsor owns the investigational product and needs to ensure results are factual and scientifically backed.
According to the definition of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a CRO is: “A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.”
The sponsor maintains a central role throughout the clinical trial process. Although regulatory tasks differ globally, they include initiating the trial process by submitting an application and ensuring approval is obtained (directly or indirectly).
The ICH Guideline for GCP specifies the responsibilities a CRO can take over from a sponsor:
- 5.2.1: A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
- 5.2.2: Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
- 5.2.3: Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
- 5.2.4: All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.
What are the advantages of outsourcing to a CRO?
A CRO can offer substantial cost savings for a sponsor by reducing the time it takes to conduct a trial compared to a sponsor doing so in-house. This also eliminates the need for staff, infrastructure and lab and office space for the sponsor to run the trials themselves. Finally, a full-service CRO can provide access to a global network of clinical research sites, meaning it can quickly identify suitable sites for clinical trials in multiple countries. Geographical reach or therapeutic focus can be important in patient recruitment, especially in specific populations, such as underserved and diverse , or for rare diseases that affect a small subset of people.
Working with a CRO gives sponsors access to the most advanced technology and systems for data management, product development, research analysis and other clinical research services. CROs are quick to adopt the latest technologies, enabling them to provide strategic insights and advice, and to offer novel and distinctive ways to use advanced tools and adapt them to each sponsor’s needs to ensure optimal clinical trial performance. Given that CROs work with many different sponsors, they often have a breadth of experience beyond even a single large pharmaceutical company.
CROs adhere to clinical compliance on a daily basis, which requires intricate in-house knowledge of regulatory requirements and audits such as GCP (Good Clinical Practice) or GLP (Good Laboratory Practice) audits.
Sponsors conducting clinical research in a niche area such as rare disease may choose to work with a specialty CRO or a global CRO with offering such services.
How does a sponsor select a CRO?
When selecting a CRO, here are some questions to consider:
- Can the CRO offer the services that the sponsor needs?
- Does the CRO have related experience and a good track record (i.e., similar projects and references or testimonials from satisfied clients)?
- Is the CRO financially stable?
- Does the CRO have a good system for employee training and a low staff turnover rate?
- Does the CRO have the key staff members required and can it set up a team to deliver qualified results?
- Does the CRO have the required infrastructure?
- Does the CRO have a robust quality assurance system?
- Is the CRO’s team responsive and willing to work with you and communicate throughout the project?
- Does the CRO have specialty services, laboratories, digital and decentralized solutions, a clinical supplies network and other capabilities important to your drug development program?
- Will the CRO help you recruit and manage safety boards or committees?
- Will the CRO conduct audits to help you prepare to pass FDA inspections?
- Can the CRO provide general site support and project management help in addition to clinical monitoring?
- Does the CRO function as a vendor or a true partner?