Full-Service Or Specialty CRO: Which One Is Right For You?

By Anne Bush, independent biometrics consultant, Bush Consulting Services

I've spent several years on the receiving end of RFPs, crafting pricing and messaging to entice biotech and pharma companies large and small to choose my CRO as a vendor. From this perspective, I have spent a lot of energy ensuring that I set my organization apart from others. What value can we bring? Are we able to make our pricing competitive? What is the sponsor trying to glean from these inquiries? Why are they including our organization in the RFP process?

Sometimes, though, I am not certain that they are asking the right questions to the right people to make the best decision in selecting their vendor(s).

Whether you are looking to outsource a single trial or a large portfolio of studies, partnering with the right CRO vendor is critical in setting a solid foundation for downstream success, and this all starts with which companies you engage in your RFP process. The pool of capable CRO organizations from which to choose is vast, so when the time comes for biotech and pharma organizations to select whom they should outsource, there is no one-size-fits-all answer or "best" option. There are, however, considerations during the selection process that will lead to the best match for your organization, and aligning your vendor selection to your core business needs is the first step in creating a CRO partnership that will best execute on your behalf.

Before requesting a proposal from well-known companies or industry giants, take a moment to consider fit with your organization. This moment is your opportunity to align your goals and lay the groundwork for a long-lasting and collaborative partnership with your CRO vendor(s). 

When deciding on CRO organizations to include in the bidding process, there are various factors to consider, such as size, cultural fit, and therapeutic area experience. A helpful place to start when determining which CROs to invite is whether you should utilize a full-service CRO, specialty CRO, or some combination thereof.

Full-service CROs provide the end-to-end services necessary to conduct a clinical trial (including project management, site selection and management, data management, biostatistics, clinical monitoring, regulatory affairs, pharmacovigilance, etc.), whereas specialized CROs offer a limited range of services or expertise. There is a broad range of specializations, and examples would include a focus on a specific therapeutic area (e.g., oncology, rare disease), service (e.g., data management), phase of development (e.g., preclinical, Phases 1-4), medical product type (e.g., device), and region. The best fit for your organization depends on several factors. 

1) Is your trial complicated or non-standard?

By selecting a specialty CRO, you potentially gain direct access to specific expertise and guidance. Clinical trials are becoming increasingly more complicated, even in Phase 1. If your organization does not have the expertise internally with the less conventional elements of your study, such as protocol complexity (such as multiple disease types or variable dosing schedule) or operational complexity (such as cold chains or long study durations) then direct access to experts can prove invaluable. It is not to say that a full-service CRO will not have experience in a particular specialty (for example, they may have run several oncology trials but do not restrict their offering to oncology) but rather that you will likely have access to individuals who have direct and in-depth experience navigating the space to guide your team and supplement your internal capabilities. 

2) How much oversight will your organization be able to provide?

Similarly, will you have someone within your organization that can choose, coordinate, and oversee multiple vendors? Biotech and pharma organizations can benefit from allowing full-service CROs to coordinate timelines and communications between internal business units, assuming that there is an established methodology within those organizations to do so.

Consider this scenario: Coordinating multiple vendors across different studies within a portfolio will present a significant challenge for your internal team, and your organization is looking to initiate several trials running in quick succession. Teams will need to coordinate timelines across studies and business units. In this case, a full-service provider may be able to provide a streamlined and simplified contractual arrangement, quicker startup, ongoing project management, and potential cost savings.

3) How budget-conscious do you need to be?

There are often cost advantages when you bundle services with the same CRO. That said, several factors affect CRO costing models, so I would be remiss to say that a full-service CRO is consistently less expensive than specialty providers, or vice versa. When budget is paramount, it is worth exploring both full-service and specialty providers to see who may give the best overall pricing. Ensure, however, that you are comparing apples to apples in terms of scope, expertise, project management support (internal and from the vendor), etc. before you jump on the "lowest" priced option.

4) How adaptable do you need your CRO to be?

Specialty providers tend to provide more flexibility and offer individualized solutions tailored to customer needs. It is not uncommon for a mid-study pivot of timeline, data strategy, assumptions, or scope to take place, impacting timelines and budgets. A specialty provider may be more adept at navigating these changes. From another perspective, specialty providers may be more limited in terms of capacity or expertise outside of their specialized field.

Consider this scenario: Your organization identified your upcoming trial as a good candidate for adaptive design, which allows for planned modifications based on data gathered while it is ongoing. When executed properly, this approach could result in significant cost and time savings, but doing so improperly could ultimately jeopardize the trial's validity and integrity. A high-touch and flexible biometrics specialty vendor experienced in adaptive designs might be the right choice to guide you through the process.¹

5) Does the CRO have the capacity and expertise to support your long-term organizational goals?

I have seen an increasing number of RFPs from small to midsize organizations requesting outsourcing by program or portfolio rather than individual trials. Biotech and pharma organizations are planning for the future and banking on success, and by utilizing the same organization from early through late phase trials for a drug portfolio, they can leverage institutional knowledge and create consistency in delivery. By doing so, there is a lot of potential reusability downstream (read: cost and time savings). The right vendor for your next step might not be the best one when you examine your subsequent moves. This approach also opens the door to a deeper CRO partnership, allowing for infrastructure development and joint innovation during long-term collaboration.

Consider this scenario:  You have a robust pipeline in a single therapeutic area and expect downstream that you are going to submit to several regulatory authorities for approval. In this instance, it may be best to seek out a CRO that specializes in that therapeutic area to guide you through the specific challenges associated with that niche, assuming that the CRO will be able to scale appropriately.

Ultimately, a strategic approach to outsourcing might result in selecting a full-service vendor, a specialty vendor, or some combination of the two, and those needs may evolve. 

Evaluating the benefits of various options allows organizations to get off on the right foot with their vendors starting with the RFP, and this is one of many considerations when selecting a CRO. By selecting a CRO that aligns with your objectives, an organization establishes the basis for a long-term partnership with the highest probability of success.

Once your vendor list is complete and you are confident that you have chosen capable CRO(s) that align with your culture and business needs, it is time to consider what types of long-term investments in the partnership will translate into improved efficiency, cost, and overall successful execution of your studies. Next time, we'll delve into how to maximize your vendor relationships and tips for effective ongoing collaboration.

Reference:

1. https://www.fda.gov/media/78495/download

About The Author:

Anne Bush, MSc, is an executive consultant who has spent nearly two decades supporting the clinical development industry. For the last 10 years, she has been focused on operational excellence in biometrics, optimizing partnerships, and guiding the strategic direction of engagements as an operations leader, account manager, and client liaison. Anne’s career trajectory bridges technical leadership, operational leadership, and business development.