Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory Obligations (TORO) brings with it a range of advantages to the Sponsor. However, because the Sponsor is ultimately responsible, they must be aware of the drawbacks of giving a CRO so much responsibility.
If you’re considering CRO services, we’ll explain what you need to know including an overview of what they are along with the pros and cons of working with them.
A Contract Research Organization (CRO) is a third-party firm that provides clinical research services including drug discovery, comercialization, pharmacovigilance, and post-approval services. Sponsors can hire a full service CRO to fulfill these functions and outsource clinical trials completely. Alternatively, Sponsors can also hire a CRO to provide guidance and assist internal teams. CROs may be hired on a contract, or a project-by-project basis depending on the Sponsor’s needs.
Most commonly, CROs are segmented by the services they offer. The types of CROs include:
However, other specific variations may include a rare disease CRO, orphan disease CRO, oncology CRO, and several others.
The primary role of a CRO is to plan, coordinate, execute, and supervise processes relating to the development of a clinical trial. CRO services will vary depending on the specialization of the firm, but typical services include:
The primary reason for outsourcing clinical trials to a CRO is that the Sponsor has limited internal resources. Working with a CRO gives a Sponsor instant access to virtually everything they need to conduct a successful clinical development program.
Here are some of the positive aspects of working with a CRO:
This is perhaps the most attractive aspect of working with a CRO. The ability to delegate all of a Sponsor’s duties and functions to a CRO means that the Sponsor can operate a drug development program when they otherwise might not be able to. This enables the Sponsor to leverage several other benefits that come with outsourcing clinical trials.
Clinical trials are complex exercises in project management, collaboration, and clinical patient care. To effectively conduct trials, Sponsors can rely on CROs because they already have the necessary resources in place. When tasked under a TORO, a CRO can be relied upon to manage all the responsibilities delegated to them, saving the Sponsor a significant amount of time and money.
Time is always of the essence with clinical trials. If a Sponsor needed to create or acquire everything required to run a clinical trial, the project would suffer significant delays. Because a CRO is set up to begin work when called upon, the amount of time it takes to get a trial up and running is reduced exponentially.
In order to develop an application to market a drug in a country, the Sponsor must conduct a study in that country, which can be time and cost prohibitive for a Sponsor. However, a Sponsor can select a CRO that has research facilities and teams located across the globe, providing them with immediate access to the ability to market their drug in multiple countries.
While working with a CRO has many benefits, there are a range of challenges that Sponsors should always keep in mind. When things go right, the drug proceeds through the trial efficiently. When things go wrong, the Sponsor is exposed to significant regulatory risks because they are ultimately responsible for the quality and integrity of the trial data.
Here are issues to be concerned about when working with a CRO:
The ability to delegate duties and functions to a CRO is a double-edged sword. While delegation can mean that program tasks get completed, there is no automatic assurance that those tasks will be completed properly. This is an issue because the Sponsor retains ultimate responsibility for the program regardless of the duties and functions delegated to the CRO. If there is a problem with anything related to the CRO’s actions, the Sponsor must deal with the consequences.
By the nature of the arrangement, Sponsors are not involved with the day-to-day operations of the CRO. Consequently, a line of communication is not always clear. This fact raises concerns relating to the Sponsor’s ability to maintain oversight of the entire program. And, the larger and more complex the trial, the more difficult it is to maintain oversight. Again, if the CRO mismanages any part of the trial, the ultimate responsibility lies with the Sponsor.
Since the CRO must handle so many tasks under a TORO, and because the CRO is ultimately responsible for the CRO’s handling of the trial, the Sponsor must conduct multiple audits to protect their interests. This means conducting a prequalification trial to ensure that the CRO can provide the services that the Sponsor needs with the necessary quality. It also means conducting routine audits at points during the trial to ensure the quality of the program, and conducting an audit near the end of the program to make sure that the program is closed properly. Essentially, audits are less of a con than they are "must-haves."
The success of a Sponsor’s clinical development program depends on their ability to leverage the pros of working with a CRO while managing the cons. With a focus on oversight, ProPharma Group helps Sponsors navigate this challenge so they can have a positive experience with their CRO while meeting regulatory requirements.
At the start, we can design the qualification process and conduct a prequalification audit. This helps Sponsors select the right CRO for their program. Additionally, ProPharma Group can design a quality system that addresses compliance in its entirety and is tailored to the Sponsor’s unique needs. To manage the cons of working with a CRO, the quality system is grounded in effective vendor management and oversight processes. To maintain compliance, ProPharma Group can conduct mock audits.
When working with a CRO, the cons don’t have to be a problem. What a Sponsor needs is a systems-based approach to the relationship. That’s what ProPharma Group brings to the table. Contact us today to learn about our capabilities as a full service CRO.
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