Built to adapt: a dynamic delivery model that evolves with the sponsor
James Joyce
Senior Director, Global Project Management, Fortrea
Leader of global clinical development portfolios with extensive hands-on experience in program and project management, governance, strategic alliances, regulatory inspection readiness, commercial strategy, and building trusted relationships with executive stakeholders, sponsors, vendors and regulatory authorities including the FDA and EMA.
In cardiovascular development, the operating plan outlined in the study proposal and presented at the Bid Defense is only the starting point. Protocol assumptions are constantly tested, recruitment conditions shift, experienced sites and patient populations are heavily contested and operational risks emerge as a study moves from startup into enrollment and delivery.
For sponsors, the important question is not simply whether a CRO can follow the original plan as presented. It is whether the delivery team can detect, early and with precision when an assumption is no longer holding, recommend the right response and pivot quickly without losing control of timelines, quality, budget or the scientific objectives. That is where flexibility becomes a discipline for protecting delivery, rather than an ingenuous commitment to be adaptable.
A delivery model designed around the sponsor
Sponsors do not enter clinical development with identical structures, resources or ways of making decisions. An emerging biotech may have a small, highly specialized medical/scientific team and need direct access to experienced operational leaders who can fill capability gaps and drive execution. A larger biopharma organization may allocate a full suite of internal functional counterparts, formal governance and consistent execution across countries and programs.
At Fortrea, we shape and adapt the delivery model around these realities. That may mean streamlining touchpoints for a lean sponsor team, establishing closer functional alignment for a matrixed organization or adapting governance as the program advances. As the book of business evolves with the sponsor, the Fortrea approach must adapt accordingly.
This is a working style we try to reinforce within our own teams. We remain accessible and responsive, build close connections with sponsor counterparts and align our internal delivery objectives with the sponsor’s program objectives. The intent is to create a team that works as an extension of the sponsor’s organization while retaining clear accountability for execution.
“The delivery model should fit the sponsor, not force the sponsor to fit the model.”
Why adaptability matters in cardiovascular trials
Cardiovascular trials place particular pressures on the operating model. Multiple Sponsors and CROs may be competing for the same investigators, sites and patients. Protocols can include complex imaging, endpoint and assessment requirements, while longer programs must maintain patient and site engagement and protect data quality over several years.
In this environment, flexibility must be grounded in therapeutic and operational judgement. A change in site strategy, additional support for priority sites or an escalation in governance should be based on what the protocol, patient pathway and emerging delivery data are showing. The objective is not to change direction frequently. It is to make a controlled adjustment early enough to reduce the risk of a manageable issue from becoming a material delay.
Responsive delivery needs the ability to scale
A responsive working relationship is valuable only if the organization can convert decisions into action. Fortrea combines senior operational access and high-touch execution with the experience and global capabilities required to support complex programs across phases, countries and functions.
This combination is particularly relevant to emerging sponsors. Smaller organizations often value the accessibility, responsiveness and cultural connection associated with a specialist CRO, but their programs may ultimately require broader geographic reach, additional services or support across an expanding portfolio.
The delivery model should be close enough to understand how the sponsor operates and sufficiently experienced and scalable to support the asset as its needs change.
“The fit felt like two puzzle pieces coming together.”
A development leader at an emerging biopharma company described organizational and cultural fit as a reason for selecting Fortrea for a major global program.
Adaptability has to produce action
The clearest evidence of flexibility is what the delivery team does when conditions differ from the forecast. This may mean challenging a feasibility assumption or eligibility criteria, modifying the country or site footprint, reallocating support or escalating a decision before an emerging concern becomes embedded in the program.
On a recent study, the Fortrea team was working toward a critical first site activation milestone with a new sponsor. The process could have been completed at expected rate over the course of several days, but the team recognized the importance of the milestone to the sponsor and came together globally to complete the remaining activities late into the evening. The sponsor subsequently recognized the team’s commitment and responsiveness, knowing that this was above and beyond the study requirements and expectations, and they truly appreciated the team effort. This shows what happens when a team understands the sponsor’s priorities, aligns around a shared objective and acts when it matters.
Responsive by design, disciplined in execution
Clinical trials do not progress in a straight line, they can be unpredictable with new challenges faced every day. Sponsors should expect a CRO to bring a clear plan, but they should also consider what will happen when an assumption changes. Will the team recognize the signal early? Will the right people be accessible? Can a decision be made without unnecessary organizational delay? Does the CRO have the therapeutic and operational knowledge and reach to implement that decision consistently?
This is the practical value of Fortrea’s delivery model in cardiovascular development. We bring the accessibility, responsiveness and close connection sponsors expect from a high-touch team, supported by the experience, governance and global capabilities needed to execute complex programs.
The differentiator is not flexibility without structure. It is the ability to adapt deliberately, act at scale and keep the sponsor’s objectives at the center of delivery.