Fractional, Sponsor-Embedded Clinical Trial Operations
Fractional VP-level clinical operations leadership for oncology, rare disease, and Cell & gene therapy global clinical trial sponsors that need executive control without full-time overhead.
Choice ClinOps delivers sponsor-embedded fractional clinical operations across seven areas of focus, for small and mid-size local and global sponsors of first-in-human, Phase 1, and Phase 2 oncology, rare disease, and cell and gene therapy trials. Engagements scale to what your portfolio needs now — not to a fixed organizational chart.
The Sponsor Challenge
Growth creates risk when operating discipline does not scale with it.
Many small and mid-size local and global sponsors reach a point where trial activity, vendor complexity, geographic spread, or portfolio expansion begin to outpace internal leadership capacity. As a result, maintaining timelines becomes increasingly difficult, and the need for robust clinical trial operations is crucial. Executive oversight of CROs and vendors diminishes, leading to longer escalations, weakened visibility, and faster than forecasted fund depletion.
That is where Choice ClinOps steps in as an extension of your team, providing seamless clinical operations.
Seven Areas of Choice ClinOps Focus
Study Rescue
Restore governance, alignment, and execution in a study that is delayed, drifting, over budget, or underperforming against enrollment targets.
Sponsors engage us when milestones keep slipping without early warning, burn accelerates without corresponding progress, or a study has lost the thread between what was planned and what is actually happening in the field.
A Choice ClinOps executive embeds to diagnose the root operational causes — not the symptoms — re-establishes sponsor control over CROs, vendors, and sites, and implements a corrective execution plan with clear ownership and decision rights.
Clinical Operations Continuity Through Disruption
Protect clinical operations continuity across mergers and acquisitions, CRO and vendor transitions, portfolio shifts, management change, new funding, and new study starts.
Sponsors engage us when a transition threatens to fragment timelines, systems, vendors, and decision authority — the period when studies quietly stall while the organization reorganizes around them.
We maintain governance and decision rights throughout the transition, integrate or transition CROs and vendors without losing execution momentum, and close the accountability gaps that follow most deals and reorganizations.
Risk and Change Management
Identify and manage operational and execution risk before it becomes enterprise risk.
Sponsors engage us when complexity is rising faster than their ability to see around corners — new geographies, new vendors, protocol amendments, or a portfolio expanding beyond what the current operating model was built to carry.
We establish the risk and change management structures that surface issues early, define escalation paths that actually resolve, and keep change controlled rather than reactive. In oncology, rare disease, and cell and gene therapy trials, execution drift is not administrative — it is enterprise risk.
Study and Vendor Audits With Ready-to-Execute Strategies
Structured audits of studies and vendors, delivered with actionable remediation plans rather than findings alone.
Sponsors engage us when they need an independent, senior read on whether a study or a vendor is performing to standard — and, critically, what to do about it.
You receive a detailed audit with a ready-to-execute strategic plan: prioritized findings, defined corrective actions, and owners. Where you want it, the same executive who ran the audit can lead the execution.
Governance of CROs, Vendors, Site Networks, and Patient Advocacy Groups
Sponsor-side oversight, accountability, and performance management across every external partner.
Sponsors engage us when CROs and vendors are active but sponsor visibility is thin — surprise change orders, slow escalations, metrics that arrive too late to act on, and a growing sense that the sponsor is being informed rather than in control.
We build and run the governance layer: clear decision rights, structured oversight forums, escalation paths that resolve, change-order discipline, and performance accountability. Silos eliminated. Clarity gained. Surprise change orders eliminated.
Site and Vendor Readiness
Accelerate startup, strengthen oversight, and drive execution consistency across sites and vendors.
Sponsors engage us when site activation is slow, enrollment is underperforming, or execution quality varies by region — problems usually diagnosed as site failures that trace back to sponsor-side readiness and oversight gaps.
We assess and accelerate site and vendor readiness, strengthen site oversight and engagement, and establish the communication and execution consistency that makes strong sites productive and weak sites visible early.
Portfolio and Study Governance
Sponsor-level control, decision rights, and governance frameworks across the portfolio.
Sponsors engage us when trial activity, geographic spread, or pipeline growth has outpaced the internal leadership capacity built to govern it — and decisions are being made study by study rather than against a portfolio view.
We establish the governance framework that gives leadership a clear operating picture across studies: where decisions get made, who owns what, how issues escalate, and how resources are prioritized when studies compete.
Across all seven focus areas, Choice ClinOps works one way.
Embedded, not advisory
We are a company-to-company contracted embedded part of your team. We attend your leadership meetings, hold decision rights, direct your vendors, and own outcomes alongside your staff. A consulting engagement ends with a deliverable. Ours ends with a functioning operation.
Sponsor-side only
We sit on your side of the table. We govern the CROs and vendors already running your work — we don't replace them, duplicate them, or compete with them.
Senior executives only
Every engagement is led by a clinical operations executive with 20+ years of hands-on delivery across sponsor, CRO, and site environments. No juniors. No learning on your study.
Scaled to your portfolio
Fractional means you engage the senior capacity your portfolio actually requires — and change it as the portfolio changes. No fixed overhead, no recruitment cycle, no severance exposure.
Capacity discipline
We decline work we cannot consistently deliver to our own and your highest standard. Every client is assigned the A-Team for the full duration of the engagement. We do not bait and switch expertise.
Fit For Purpose and Size
Ideal for local and global Small and mid-size clinical research sponsors
- FIH, Phase I or Phase II local or global oncology, rare disease, and/or cell and gene therapy clinical trial operations studies
- Small and mid-size clinical trial sponsors
- Before hiring full-time staff, organizations benefit from embedded leadership, ensuring effective sponsor-side governance and oversight of CROs, vendors, site networks, sites, and processes.
- Experienced leaders provide governance during phase growth, pipeline development, global pipeline expansion, CRO transitions, or mergers and acquisitions.
- Structured execution is prioritized across lean internal teams, and processes for clinical operations team build or updates are streamlined.
This approach fosters a more mature operating model without introducing permanent overhead too early.
Outcomes
Business impact
Fractional and Sponsor-Embedded Choice ClinOps is designed to assist sponsors in optimizing clinical trial operations by achieving:
Eliminated silos,
On-time delivery,
Remain in compliance,
Ensure participant safety,
Optimize resource utilization,
Strengthen execution discipline,
Improve operational efficiencies,
Reduce avoidable delay exposure,
Streamline cross-functional decisions,
Increase effective, timely communication,
Protect burn efficiency and milestone momentum,
Enhance executive oversight to increase confidence across internal and external stakeholders.
What Makes Choice ClinOps The Obvious Choice
Why Choice ClinOps
Choice ClinOps integrates sponsor-side leadership judgment, therapeutic expertise, and budget discipline into one embedded model for clinical trial operations. This is not passive advisory work; it provides active operational command designed for high-stakes oncology, rare disease, and cell and gene therapy (CGT) clinical trial programs, ensuring robust executive oversight.
Each team member at Choice ClinOps has actively engaged in clinical operations delivery, management, and governance for over two decades across more than 30 countries, throughout Canada, the United States, South and LATAM, EMEA, the United Kingdom, and APAC. We hold ourselves, our work, and our ethical standards to the highest possible level.
To maintain our innovative edge, Choice ClinOps incorporates updated technology and systems, continues to strengthen our global network and footprint, and ensures that all team members are well-educated and experienced in efficient processes and tools.
Add senior ClinOps control without adding full-time overhead
Begin with an executive exploratory meeting with Leila Cupersmith to assess how sponsor-embedded leadership in clinical trial operations can deliver the highest return for you, your clinical study team, and your company, ensuring effective executive oversight throughout the process.