By Réne Stephens, Managing Director, Clinical Business Operations
Deciding on the right Contract Research Organization (CRO) is critical to your clinical trial success. However, many biopharma sponsors start the selection process without first engaging an outsourcing specialist. Unlike larger biopharma companies with in-house teams managing the outsourcing process, smaller organizations typically go without this specialized role. This can lead to a host of pitfalls and long-term consequences that may jeopardize your study.
- Incorrect fit. Like an outfit bought in haste, without an expert outsourcing “tailor,” executives or clinical teams may take the easy route by opting for a well-known, large CRO or one that has been recommended by a colleague or friend. While this seems like the path of least resistance, it may not always result in the best fit for the specific needs of the trial. Without proper analysis, you risk selecting a CRO that is too large or too small, or one that lacks critical capabilities your trial requires.
- Knowledge of CRO Landscape. Outsourcing specialists have their finger on the pulse of the CRO market. Without their involvement, executives may simply not know the full range of options. The CRO industry is vast, and new, innovative providers frequently emerge that may offer better capabilities, specialized expertise, or more cost-effective solutions. Without a specialist, sponsors often end up with suboptimal choices, missing out on better suited options.
- Clinical Operations Teams Have Different Priorities. Clinical operations teams rightly focus on study execution more than strategic alignment of outsourcing needs. They may not have the same objectives when it comes to due diligence and contract negotiations as someone in a procurement or outsourcing role. Clinical operations teams might prioritize operational efficiency and technical compatibility but overlook critical elements such as pricing structure, risk-sharing models, and quality guarantees. This could lead to a bad deal where the sponsor ends up overpaying or agrees to unfavorable contract terms, creating financial and operational strain down the line.
- Due Diligence Gaps. CRO selection is a complex process that goes beyond assessing basic capabilities. Without the rigorous vetting process that an outsourcing specialist provides, due diligence may be insufficient. Experts in the field guide teams through the process, ensuring a more robust and thorough analysis and freeing clinical operations teams so their focus remains on core delivery capabilities. These areas of diligence are more than just box-checking exercises as they provide the underlying rationale to support selection decisions when compliance, regulators, and/or auditors come calling.
- Poor Negotiation Outcomes. Negotiating with a CRO without the guidance of an outsourcing expert often results in missed opportunities to optimize the contract. Outsourcing specialists have experience in understanding industry standards, negotiating flexible terms, and securing competitive pricing. Without their expertise, sponsors may lock themselves into contracts with rigid timelines, lack of milestones, or high financial penalties, ultimately reducing the sponsor’s leverage in managing the trial effectively.
- Conflicts of Interest: A common but often overlooked issue is when a CEO, executive, or key decision-maker favors working with a specific CRO due to personal connections—such as a recommendation from a colleague or a previous working relationship. While these relationships may seem beneficial initially, they can lead to a bias in the decision-making process, where the CRO’s past reputation or personal relationship takes precedence over actual suitability for the current trial.
How an Outsourcing Specialist Can Help
Outsourcing specialists bring an objective, data-driven approach to CRO selection. They know how to evaluate CROs based on key indicators like performance metrics, therapeutic area expertise, geographic reach, regulatory success, and financial stability. Their primary role is to ensure that the CRO selected is the best possible match for the specific needs of your trial, not just the most convenient or familiar option.
- Broader Market Knowledge: Outsourcing specialists have a comprehensive view of the CRO market, ensuring that all potential providers are evaluated, from large global CROs to niche, specialized players.
- Stronger Contracts: They bring the experience necessary to negotiate contracts that protect the sponsor, with favorable terms, performance guarantees, and clear, measurable milestones.
- Aligned Interests: An outsourcing specialist ensures that the goals of the sponsor—whether speed to market, cost control, or quality—are the priority during the entire CRO selection and contracting process.
- Risk Mitigation: With their focus on due diligence, they reduce the risk of selecting a CRO with inadequate capabilities or poor track records.
The takeaway? Engaging an outsourcing specialist before selecting your CRO is not an added expense—it’s an investment in the success of your clinical trial. The pitfalls of not doing so are many: from selecting a misaligned CRO, to signing unfavorable contracts, to experiencing costly delays. Ultimately, an outsourcing specialist acts as a vital guide through the complex landscape of CRO selection, ensuring the trial runs smoothly and efficiently, and reducing the risk of costly errors.
In today’s competitive clinical trial landscape, where every decision can impact time-to-market, quality of data, and financial stability, engaging an outsourcing specialist is essential to achieving your goals.