What To Know Before Selecting A CRO
There is a difference between running a clinical research trial at a top ten pharmaceutical company and running one in a small to mid-size biopharma. The challenges are different, the measures of success are different, and the team available to work with the CRO is different, therefore the criteria to select your CRO must be different. A CRO providing services to this market must be willing to be flexible, must resource your trial appropriately, and must value your trial. Asking the right questions up front can help biopharma companies find a CRO that understands the unique needs of this market.
Here are four considerations that are often forgotten during the CRO selection process that can make an impact.
Think about consistency.
Consistency is a huge driver to the delivery of trial timelines. There is a saying about competing interests within large CROs, “when (insert any top ten pharma) sneezes, the biotech companies catch the cold”. Ask how a CRO plans to provide consistency for your trial. Are project teams assigned for the life of a trial? Or can they be removed and placed on other projects? Too many personnel changes are hugely disruptive and can impact timelines. Also ask how a CRO plans to minimize duplicate efforts across trials if there are multiple studies in a program. This will help you avoid unnecessary cost, save time, and maximize efficiency.
Remember that therapeutic experience does not guarantee high performance.
CROs are often chosen because of their depth and breadth of experience in a given therapeutic area. However, that experience is not always enough to make a successful trial. Missing timelines and going over budget has so much more impact on a small to midsize biopharma than it does in a large pharmaceutical organization. It can mean the life or death of a company, or more importantly the loss of a life changing drug that could have been delivered to patients. Choosing a CRO should include therapeutic experience, but should also take into account the delivery of the trial and how they will provide flexibility, consistency, and transparency to deliver on time and on budget. Look for CROs that actively work with and value the relationships with businesses similar to your own in size and structure. These CROs will understand your needs, be willing to adapt to meet these needs, and be true partners in reaching your goals.
Look out for anything missing in the cost estimate.
Budget transparency is key, especially when funds are limited. Ask CROs if they provide unit-based costing structures and beware of the change order! A low budget up front can prove to be costly over time. Ask for realistic budgets at the outset, and be alert to over-conservative bids that don't cover the full project scope. Multiple change orders post-award drive up all-in costs and create timeline risks.
Ensure that there's inherent flexibility.
One size does not fit all. Ask CROs if they offer their services a-la-carte in order to ensure the best fit and the best outcome for your study, not a package deal. Just because a CRO offers a service, does not mean that it is the right fit for your specific trial. A CRO that works with biopharma companies on a regular basis understands that they each bring different strengths to the table, and that there needs to be a high degree of flexibility for what they keep in house and what they ask their CRO to take on.
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Tags: Clinical Outsourcing