You Just Secured $50 Million. Now On To The Hard Part: Clinical Trials
By Tom Wells, director, life sciences, 4C Associates
It’s Monday, 9 a.m., and you’re refreshed and ready to go. You spent the weekend in a state of happy exhaustion because, on Friday — after months of pitch decks and projections — you finally closed your funding round. You now have $50 million of Series A funding to begin the journey from molecule to market.
Your first priority is to launch your clinical trials. But there’s one problem: Although your team has been involved in many trials, it’s unlikely that any of you have ever handled the full process of selecting the right CRO, negotiating contracts and costs, onboarding, and managing performance.
You’re not alone. Early-stage biotechs often face this paradox. Clinical trials represent their largest investment — frequently consuming most of their capital — yet they rarely have the procurement expertise, systems, or infrastructure required to approach sourcing and vendor management effectively. This lack of sourcing maturity often leads to inefficiencies, rising costs, and operational risks that can delay milestones or derail programs altogether.
This article explores some of the pitfalls and shows how early involvement of sourcing professionals can improve delivery, control spend, and help retain oversight of your most valuable asset — the clinical trial.
Limited Internal Sourcing Expertise
In the absence of dedicated sourcing professionals, clinical scientists or project managers often lead vendor selection and contracting, despite having limited knowledge of pricing models, CRO landscapes, or supplier performance. This leads to unclear scopes, weak negotiations, and gaps in oversight.
More importantly, a robust, well-documented sourcing process is vital when preparing for inspections or future due diligence, whether for additional funding rounds or potential acquisition.
The solution is to bring in sourcing professionals early. If your company lacks in-house capability, interim experts or external advisors can bridge the gap from the planning and feasibility phases onward. They’ll apply standardized procedures to ensure all aspects of sourcing are managed appropriately and transparently.
CRO Selection
Selecting the right CRO should be a considered, structured process. But under time pressures and lacking detailed market knowledge, teams often default to CROs they’ve worked with before, regardless of whether they’re the best fit for the current study.
Sourcing professionals offer up-to-date market insight, familiarity with key players, and the ability to refine the long list into a manageable shortlist. They’ll lead a rigorous RFP process, using standardized tools such as proposal templates, budget grids, and task ownership matrices. This standardization enables fair comparisons and makes inconsistencies easier to identify and address.
Protocol Design And Feasibility
Protocols typically reflect scientific goals but can overlook operational realities and patient perspectives. The result? Impractical designs, high screen failure rates, and costly amendments. CRO budgets based on flawed assumptions introduce additional risk.
Site feasibility is often based on surveys or anecdotal input, resulting in poor site selection and inaccurate enrollment forecasts. Sponsors should instead use data-driven tools, incorporating real-world data and historical site performance.
CROs can play a valuable role in testing the feasibility of the protocol, but their input must be carefully managed. Some sponsors choose to pay for stand-alone feasibility assessments, sometimes deducting the cost if the CRO is later selected. Others adopt a phased approach, where the selected CRO supports protocol refinement before the full study budget is finalized and site initiation begins.
Subcontractor Oversight Gaps
CROs frequently subcontract key services, such as central labs, eCOA providers, or local monitors, without the sponsor’s full visibility. This creates compliance and quality risks.
A sourcing lead can help sponsors contract directly with these vendors, giving greater control over costs and deliverables. Where subcontracting is necessary, such as when a CRO lacks coverage in a particular region, this must be captured in the main contract with clear responsibilities and full transparency. Subcontractors must also be appropriately qualified and documented.
Sponsors retain ultimate responsibility for all vendors under ICH GCP. Delegation does not remove accountability!
Performance Metrics And Incentives
Generic key performance indicators (KPIs) and time-based billing models often fail to promote performance. Without appropriate incentives or penalties, CRO priorities can drift from those of the sponsor.
Sourcing professionals define KPIs that reflect true delivery outcomes, such as recruitment rates, data cycle times, or protocol deviation management. They also support shared dashboards and joint governance structures. Most importantly, they build incentives and penalties into contracts, driving alignment and focus.
Cultural And Operational Disconnects
In the rush to start trials, operational planning often takes a back seat. The push to identify sites and enroll patients quickly can lead to mid-start-up protocol amendments. These affect both budget and delivery assumptions, creating unnecessary complexity.
Cross-functional collaboration between clinical, sourcing, finance, and regulatory teams at the outset prevents this. Joint planning, clear role definitions, and structured handovers enable better coordination and more consistent delivery across functions.
Inefficient Budgeting And Cost Control
CRO budgets frequently contain vague language and inflated costs. Without benchmarks or reference points, sponsors struggle to challenge assumptions, leading to overruns and unpredictable expenditure.
Sourcing professionals can guide teams to industry tools that support realistic budgeting, enable cost per site per year modelling, and encourage milestone-based payment structures. Regular tracking of budget versus actual spend provides valuable insight to inform future contract negotiations.
Lack Of Strategic Vendor Relationships
Early-stage companies often treat CRO engagements as one-off transactions. While this may offer perceived flexibility, it limits continuity, institutional knowledge, and overall efficiency.
A more strategic model can offer better results. Preferred provider panels and modular outsourcing frameworks promote consistency and allow you to build on past learnings while still maintaining flexibility. Ongoing relationship management — through regular check-ins, performance reviews, and continuous improvement — supports stronger vendor performance and mutual accountability.
Conclusion
Outsourcing is not just a transactional or financial task; it’s a core operational capability. For early-stage biotechs, the success of a clinical program often depends as much on how it’s sourced and managed as on the underlying science.
Common pitfalls, such as weak contracts, unrealistic protocols, poor feasibility data, and inconsistent oversight, can derail even the most promising trials. These risks can be significantly reduced by involving sourcing professionals early, fostering collaboration across functions, and establishing robust performance management.
Of course, once your company’s trials are up and running, you’ll need to think about other critical areas for your growing company — like finding the right insurance broker, setting up employee benefits, sourcing IT systems, or hiring a PR agency. But those are topics for another day.
About The Author:
Tom Wells is director of the life sciences practice at 4C Associates. With a background in brand management, marketing, and marketing consultancy, he joined Novartis as global procurement lead for marketing in 2011, subsequently moving to Takeda as global procurement lead for travel, meetings and events in 2015. He joined Bristol Myers Squibb in 2019, holding regional and global leadership roles in strategic sourcing & procurement and in commercialization before moving to 4C Associates in March 2025.