For the pharmaceutical industry, outsourcing to contract research organizations (CROs) is an integral part of drug development. Both large pharma and smaller biotechs working with CROs for clinical trials expect the overall level of outsourcing to continue to grow in 2017.
Many CROs provide support for drug and/or medical device clinical trials and clinical trials, providing their clients with the expertise and resources to move a new drug or device from concept to FDA or EMA marketing approval without the drug sponsor having to maintain staff for these functions . According to Wikipedia, there are over 1,100 CROs in the world, some with annual revenues of up to $4.3 billion.
Choosing the right CRO to manage a clinical trial can be a critical decision for the successful outcome of the program. What kind of evaluation criteria should be used when there are so many CROs to choose from? In many ways, choosing a CRO is no different than choosing any other vendor; however, the sponsor-CRO relationship also has its own unique nuances. We recommend evaluating CROs based on the following eight categories:
1. PORTFOLIO OF EXPERIENCE AND SERVICES
When evaluating a contract research organization, it is important to assess the company’s experience, but especially their experience in your therapeutic area. Get an idea of their track record and whether they have consistently served their clients. Ask about the specific types of exams they’ve worked on. Different stages of drug development require different skill sets. Phase I trials can be very fast, while Phase III can be very demanding.
woman in protective glasses looking at a test tube Next, evaluate the company’s employees in terms of quantity and quality. If the scope of the project is large, there will be an interest in the number of employees. If the project requires specialized expertise, then the quality of staff (number of PhDs etc.) may be more important. Find out the structure of the team you will be assigned and whether it will be supported by executive management.
Also, find out the scope of what a CRO can provide. CROs with a wide range of services in different therapeutic areas may be better suited for companies conducting multiple studies. On the other hand, depending on the needs of the study, specialized CROs or CROs with experience in less therapeutic areas may be the right choice. Identification of key capabilities and new areas of expansion should also be considered.
2. FINANCIAL STABILITY OF CONTRACT RESEARCH ORGANIZATION
CROs inherently operate with significant business risk because their work involves developing products that may not ultimately be approved and commercialized.
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Clinical trials can be canceled at any time for any number of reasons, so it’s important to ensure that the CRO you choose has enough financial bandwidth to weather industry uncertainties without negatively impacting your project. Ask how long the CRO has been in business and assess whether their portfolio of projects is sufficiently diversified to mitigate unforeseen “bumps in the road.”
3. INFRASTRUCTURE, PROCESSES AND SYSTEMS
Appropriate CRO infrastructure is essential to support your project requirements, so your due diligence should include a thorough examination of whether the CROs you are considering have sufficient equipment and staff to handle your project requirements. Ask what software they use to track project performance and how their clinical information system is organized.
Do they maintain clinical data in a manner that complies with 21 CFR Part 11? What steps need to be taken to export the data held in the CRO to your company’s system and is the process secure? What process does the CRO use to facilitate sponsor review of clinical trial data? How does the CRO manage the necessary study documentation?
4. ACCESS TO SITES AND PATIENTS
One of the benefits of outsourcing your clinical trial CRO is that it may have access to investigator sites or specific patient populations that your company does not have. This type of expertise can be helpful in landing “productive” positions, that is, positions with a proven track record of acquiring valuable patients and providing high-quality patient data.
A critical factor in site selection is the expected rate of increase or patient recruitment. Investigators often overestimate the number of patients meeting the entry protocol that they can admit at any given time. Make sure your CRO has a proven track record of determining the actual number of patients who meet study inclusion and exclusion criteria.
5. VALUE OF CONTRACT RESEARCH ORGANIZATION
While cost-effectiveness will be a key selection consideration and a desirable benefit of a CRO partnership, it is usually not the primary criterion. More attention is pay to the evaluation of the quality and expertise of the services for the propose scope of work.
Cost may also play a greater or lesser role depending on the type of project consider. In a more transactional purchase—for example, a single study with low study complexity—cost may be more influential, while other factors will weigh more heavily in a strategically driven selection process.
For smaller companies, cost will likely be a bigger consideration, but beware of extremely low bids, which could indicate that the CRO has not considered the true scope of the project or underestimated the resources required for the project. Likewise, a high bid does not always mean that the sponsor will get a more experienced or better team. Some CROs have large overheads and administrative costs that must pay back after one project.
Also, realize that cost is not just a monetary matter, but includes the value you get from that cost.
6. TRANSPARENCY
What do you expect from transparency? Sponsoring organizations often assume they will have full visibility into study progress and milestones, only to find that transparency is not high on their CRO priority list. If transparency is high on your list of selection criteria, it should actively communicate and monitor at the time of the deal. You may want to make access to the CRO’s clinical systems a requirement of the relationship.
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Transparency can be especially valuable for sponsors who use multiple CROs and need visibility across multiple systems. This allows sponsors to provide adequate oversight without having to add unexpected resources. Full transparency of operational and patient data also helps justify the addition of additional resources and budget allocations when needed.
7. PARTNERSHIP FOR COLLABORATION
A selection criterion that is sometimes overlook is the CRO’s ability to work in true partnership with the client company. Partnerships mean different things to different people, so it’s important to assess whether the CRO team members will perform the study functions as well as you would on your own.
Assess the level of ownership and accountability of CRO team leaders by asking for specific examples of how they have solved past study problems as a team. Do they have the same goals for their studies as you? Are they invest in the credibility and success of the studio? If the CRO team feels ownership of the study, the relationship will function as a true partnership and the process will flow smoothly.
8. RESPONSE IN REAL TIME
Everyone knows that responding quickly to challenges or problems can be the difference between a quick solution and a problem that spirals out of control. Don’t make the mistake of focusing solely on evaluating a CRO team based on their technical skills and miss the importance of critical business skills. Even a short delay in corrective decision-making can lead to very expensive outcomes, such as protocol changes, multiple deviations, and even the need to enroll additional patients or repeat the study.
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Decisions need to make with certainty in real time, so sponsors are not at risk of missing milestones. The ability to make quick decisions based on up-to-date operational and patient data is a quality that should value in order to achieve the full potential of the Sponsor/CRO relationship. Ensure fully integrated team members, both CRO and sponsor, have access to real-time data to ensure they can quickly adapt to unexpect events that often occur during the course of a study.
CONCLUSION OF CONTRACT RESEARCH ORGANIZATION
When evaluating CROs, take a rigorous and disciplined approach that considers both tangible and intangible factors. Qualified CROs will have experience and expertise in your therapeutic area. Organizations will be financially stable, demonstrate an understanding of true partnership, and demonstrate adaptability to make real-time adjustments when needed. A good CRO also facilitates adequate study oversight and documentation to enable their sponsors to efficiently and effectively achieve quality clinical trials.
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