In drug development, the earliest phases carry both the greatest uncertainty and the greatest opportunity. Early phase clinical trials, whether healthy volunteer studies or first-in-human oncology work, are where feasibility, safety, and the initial value of an asset are tested. What happens here can set the tone for the rest of the programme.
When early phase trials go right, they provide a confident “go” decision backed by high-quality data. When they go wrong, they can stall timelines, drain budgets, and jeopardise years of work. That’s why picking your contract research organisation (CRO) is more than simply a choice among various vendors. Choosing the right CRO partner is a strategic risk management decision with real consequences for future phases.
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Early phase as a strategic inflection point
Trials in the early phase are where sponsors have the opportunity to test feasibility, uncover risks, and make critical go/no-go decisions. At this stage, issues such as safety signals or suboptimal dosing can be identified before large-scale investment is committed, saving years of time and millions of dollars downstream.
Effective operational planning helps sponsors avoid delays that often cascade into later phases, while the generation of a high-quality, regulatory-ready data package sets the foundation for smooth interactions with agencies. For instance, imagine a biotech developing a novel oncology therapy: in a well-executed early phase study, the sponsor discovers that a slightly lower dose maintains efficacy while significantly reducing adverse events (AEs). This insight not only informs protocol design for Phase II but also strengthens the company’s position with regulators and investors, enabling an efficient transition to later development. In this way, early phase goes beyond simply “checking the box” by helping to de-risk development and maximise long-term value.
Ideally, sponsors should work with therapeutically focused CRO partners who can navigate through the complexities of study start-up and execution but also have a specialised later-phase team with deep scientific, operational, and regulatory expertise. These later-phase colleagues can then better collaborate to ensure early decisions align with downstream regulatory and commercial needs.
This way, sponsors get a single point of contact with visibility into progress, risks, and milestones, while cross-team meetings and decision checkpoints allow issues to be resolved before they affect timelines. Longstanding relationships with sites, labs, and vendors translate into smooth logistics and accelerated operations. These are critical but sometimes overlooked factors in an environment where every week saved has strategic and financial impact.
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By GlobalDataReal-world examples of why firsthand unit experience matters
While some CROs claim to offer early phase services, not all have the operational depth to truly de-risk them. The differentiating factor often is the firsthand experience inside phase one units.
For instance, it’s incredibly helpful for early phase project managers who have firsthand experience working on the floor in Phase I units managing screenings, check-ins, dose administration, real-time safety monitoring, and all the real-world complexities that come with it. Many members of the Emerald EP team have this background, giving them a deep understanding of where protocols meet practical constraints because they’ve lived it.
That experience translates into 1) operational feasibility checks that flag and fix bottlenecks before they occur, 2) optimised scheduling that balances safety, protocol compliance, and site capacity, and 3) rapid troubleshooting from teams who recognise patterns and act immediately.
Team members without prior unit experience are brought on structured site tours and shadowing so they understand the flow, pressures, and decision points unique to early phase. These examples show why institutional knowledge exchanges are key to consistent, high-quality execution.
Getting the right patients, faster
In early phase oncology, speed and precision in recruitment can make or break a study. The right CRO will offer tailored, patient-centric recruitment strategies matched to trial complexity and direct access to target patient populations through high-performing sites. Strong KOL relationships to refine protocol design and optimise site selection round out additional factors that result in consistently high recruitment and retention rates, fewer protocol deviations, and faster paths to proof-of-concept.
One integrated team, end-to-end
A “one team” model minimises handovers and maximises efficiency, ensuring that expertise is shared seamlessly across the study lifecycle. When cross-functional team members bring direct, hands-on early phase experience, they can accelerate site activation, design protocols that are both scientifically rigorous and operationally feasible, and manage risks proactively rather than reactively. This integrated approach naturally shortens timelines and improves data quality.
Just as importantly, strong, long-term relationships with investigators, sites, and vendors create smoother logistics, higher protocol adherence, and more consistent patient recruitment and retention. For example, in a first-in-human oncology trial, a unified team might anticipate a potential scheduling conflict between dosing cohorts and lab capacity, redesign the visit schedule before enrollment begins, and prevent a weeks-long delay. By catching that issue early, the sponsor not only keeps the trial on track but also preserves data integrity and patient trust. These two factors directly influence long-term development success.
Adapting to regulatory shifts
Regulatory shifts have become more prevalent of late. The US Food and Drug Administration’s (FDA) Project Optimus guidance is one such example that has changed how early oncology trials are designed, emphasising dose optimisation rather than simply finding a maximum tolerated dose. Sponsors and their CRO partners must therefore integrate adaptive trial designs, complex multi-cohort dosing strategies, and PK/PD analyses into studies from the outset.
By engaging KOLs and regulatory experts early, the CRO can help sponsors meet regulatory expectations, minimise protocol deviations, and generate stronger safety and efficacy data. This includes strategic support for FDA interactions such as End of Phase 1 (EOP1) meetings to keep programmes on track.
Managing risk, maximising value
In early phase, there is no margin for “good enough”. Every decision carries weight, and every operational detail can affect the quality of the data and the future of the asset.
By working with a CRO whose people have experienced early phase from the inside, sponsors gain more than project management. They gain a strategic partner able to anticipate challenges, navigate complexity, and keep programmes moving forward with confidence.
