Clinical Trial Management Services

Running a clinical trial means orchestrating dozens of moving parts: sites, vendors, budgets, timelines, data and regulatory obligations. Zanteris provides clinical trial management services that take that operational weight off your team, so your study is delivered on time, on budget and to quality, while you stay focused on the science.

 

End-to-end clinical trial management for sponsors

We support small and mid-sized biotech, pharma and medtech sponsors across the full study lifecycle, from protocol feasibility to close-out. Whether you need someone to build your operational strategy from scratch, rescue a study that is drifting, or act as your day-to-day trial management office, we adapt to the maturity of your organisation. With 17+ years of clinical operations leadership and 75+ studies across oncology, immunology and cardiology, we bring CRO-grade rigour with the flexibility of a consultancy.

  • Study planning, feasibility and operational strategy
  • Budget development, contract negotiation and financial oversight
  • Timeline, risk and quality management across all study phases
  • Governance, KPIs and transparent sponsor reporting

 

Vendor management in clinical trials

Most trial risk hides in the hand-offs between vendors. Our clinical trial vendor management service covers the entire chain: defining your outsourcing requirements, building the vendor long list, running the RFP, scoring proposals, and preparing you for the bid defense meeting. Once contracts are signed, we set up oversight plans, KPIs and escalation paths so issues surface early, not at database lock.

Because we have sat on both sides of the table, sponsor and CRO, we know where margins are padded, where timelines are optimistic and which service assumptions deserve a second look. Read our guide on how to choose a CRO for the criteria we apply.

 

Clinical trial outsourcing: choosing the right model

Full-service CRO, functional service provider (FSP) or a hybrid model? The right clinical trial outsourcing strategy depends on your pipeline, your internal expertise and your budget horizon. We help you compare models objectively, quantify the trade-offs and implement the one that fits, including transition planning when you change vendors mid-programme. Learn more about the functional service provider model and when it beats full-service outsourcing.

 

What is included in our clinical trial management services

  • Vendor and CRO selection, RFP management and bid defense preparation
  • Vendor oversight: governance, KPIs, issue and escalation management
  • Clinical trial project management through our dedicated project management service
  • Risk-based quality management and inspection readiness
  • Budget and change-order control across vendors
  • Rescue and remediation of underperforming studies

 

Why sponsors work with Zanteris

Zanteris is a Lyon-based clinical research consultancy working with sponsors across Europe and North America, in English and French. You get senior expertise only, no juniors learning on your study, engaged in a model that flexes with your needs: fractional, project-based or interim. We are members of PMI and PCMG, and our work has been recognised by Life Sciences Review (Top 5, 2023) and Silicon Review (2025).

 

Frequently asked questions

What are clinical trial management services?

They cover the operational management of a clinical study on behalf of the sponsor: planning, vendor and CRO oversight, budget control, risk and quality management, and reporting. Unlike hiring a full-service CRO, a trial management partner works on your side of the table and keeps you in control.

How is this different from hiring a CRO?

A CRO executes trial activities; Zanteris manages and oversees them in your interest. We are independent from the vendors we help you select, which removes the conflict of interest inherent in asking a CRO to oversee itself.

How do you charge?

Engagements are scoped to your need: a defined project (for example a vendor selection), a fractional ongoing role, or interim cover. You pay for senior time only.

Planning a study or unhappy with a running one? Book a call to discuss how our clinical trial management services can help.

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