By Kamila Novak, KAN Consulting
Selecting the right CRO to conduct our study is not a difficult task, right? We just need to decide if we want a one-stop shop for all study activities or a functional service provider (FSP) that gives us the capabilities or expertise we lack.
Well, there is more in it than that. We can include aspects such as the time zones and ease of communication, the size of the CRO, the type of the CRO, etc.
The time zone piece is very straightforward. If we want to talk to the CRO’s project manager and we are on the West Coast, an Australia-based project manager would be hard to reach. Hence, a reasonable time difference with at least two common hours during our business days will help. Otherwise, our communication will suffer from a default delay of one business day (without considering different holidays).
How does the CRO’s size matter? Quite a lot. If we are a tiny biotech company, we are likely an insignificant client for a large global CRO. Would they listen to us? Pay attention to our needs? Or rather follow their SOPs and attend to their big clients? The answer is obvious.
How about the CRO’s type? There are so many to choose from – a global CRO, a regional CRO, a niche CRO, typically having a special expertise in either a study phase or a therapeutic area, or a boutique CRO, whatever that means. For me, the latter is instinctively associated with higher charge-out rates; you don’t expect the same prices at a Whatever Avenue boutique and Walmart, do you?
So, our selection of the right CRO is getting more complicated. How do we navigate to the right decision? Should we contract a clinical subject matter expert to help us with the preparatory steps and build our business case? This can save us time, possible false expectations, and wrong estimates. We need to keep our strategy in mind. Supposing our study is successful, do we plan to sell the license or continue development of the product? How far can we take it?
1. First, we should agree internally on our needs, requirements, and priorities.
What exactly do we need in terms of services, quality, and timelines? Which capabilities do we have in-house, and which are we lacking? If we aspire to be fast, can we achieve it without compromising the regulatory-mandated quality? We are likely going to be very ambitious regarding timelines, so researching industry metrics can bring us closer to reality, e.g., reading Tufts publications, since they are not biased toward advocating their technology solutions to shorten the start-up time. We can also review various CROs’ offers or just their websites where they present the technologies they use and read articles they publish. We should remember that every company publishes their success stories; however, it does not mean every study they conduct is a success story. So, we should prepare very specific questions to ask our potential service providers and request them to support their answers with data. For example:
- Can you guarantee the study team will remain stable during the study? How will you ensure that?
- Will you commit to keeping the project manager unless we ask for replacement?
- What are your average study start-up timelines for Phase 1 studies? Can you show us your historical data? What percentage of your studies falls behind the time plan?
- How will we get real-time information on the study status? Will you give us access to your CTMS?
- Can you guarantee your deliverables will meet our quality specifications? How will you ensure that? Can you show us data (number of critical, major, and minor findings) from the audits and inspections you have passed?
I know, curiosity killed the cat, but in this case our curiosity is not only justified, not asking these questions can lead us to hasty decisions we may later regret.
2. Second, let’s consider our budget.
We do not have products on the market yet, our budget is limited, and we should be careful about spending. Besides, we are accountable to our investors. What is a reasonable risk budget to keep aside? Where can we save and where is it unwise to save? How do we build a healthy budget? Where can we get some typical cost information for manufacturing, logistics, CRO services, investigators’ fees, fair market values, etc.? Unlike large sponsors, we do not have historical data. A time-saving solution can be contracting or employing (for confidentiality reasons, budgets are sensitive) an experienced clinical contract manager with the knowledge we need.
3. Third, let’s think about the number of providers and vendors to engage.
Having one provider that will do or secure all the services sounds appealing; however, then we need a large CRO, and we are back to the questions about company size, attention, and charge-out rates. What if they terminate the contract for some reason (e.g., we delay paying their invoices due to renegotiating with investors)? We will have huge problems. Going to the other extreme and engaging too many smaller providers will be challenging in terms of their qualification, oversight, and some level of coordination and project management that we still need to provide. Do we want to build some functions, e.g., safety or data management, internally? Now or later? What is the right number of providers for our company?
A useful approach may be to chart all important activities needed in the study, e.g., study management, clinical operations including site monitoring, safety monitoring, data management, pharmacovigilance, supply chain, regulatory affairs (submissions, periodic and ad hoc reporting to authorities), medical writing (protocol, informed consents, clinical study report, safety reports), special laboratory tests and potential need for central laboratories, study-specific equipment needs (e.g., infusion pumps), Trial Master File (development, maintenance), quality assurance and quality control, and long-term archiving. For practical reasons, which activities should be preferably handled by one provider and which by another one? Which providers do we want to contract and manage ourselves and which can be subcontracted by one of our CROs (e.g., couriers or labs)? This can help us to narrow down the number of CROs.
The number of CROs to involve indirectly drives their probable size. If we want one CRO to handle clinical operations, data management, medical writing, regulatory affairs, study management, and contract couriers, it cannot be a tiny company; however, it does not have to be the largest one. Most CROs offer all these services. If we need them to be experienced in Phase 1 studies, this may limit our choices to some extent. If we want them to have experience in both Phase 1 studies and our target therapeutic area, this will limit our choices even more. The more requirements we claim as “must-haves,” the fewer choices we will have. If we want another CRO to do the pharmacovigilance, this can be a relatively small company specializing in this area.
4. Lastly, we need to think about CRO location with regard to our study population.
Are we planning to recruit healthy volunteers or patients? If patients, is the therapeutic indication rather common or rare? If rare, where are these patients likely to be found? Are there geographical differences? We need our CRO to be located close to our future study participants. If the indication is relatively common, what are the differences in costs depending on the location? Are there differences in regulations (e.g., not allowing Phase 1 studies)? Are the facilities there suitable for Phase 1 studies? Are the investigators experienced, meaning can we find publications in journals with impact?
Once we clarify our needs, requirements, priorities, budget, and the desired number, size, and location of providers, we are in a good position to start looking for potential best fits.
About The Author:
Kamila Novak, MSc, got her degree in molecular genetics. Since 1995, she has been involved in clinical research in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant focusing on QA and QC, as a certified auditor for several ISO standards, risk management, medical writing, and training. She is a member of the Society of Quality Assurance (SQA), the World Medical Device Organisation (WMDO), the European Medical Writers’ Association (EMWA), the Drug Information Association (DIA), the Continuing Professional Development (CPD) UK, and other professional societies.