Clinical Trial Project Management

  Clinical Trial Project Management Services I CRO Services  
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Clinical Trial Execution, From Start to Finish

Our dedicated project management teams ensure every trial is delivered with precision, quality, and speed, no matter the complexity. We combine agile project leadership with deep therapeutic expertise to accelerate timelines and improve data quality, ensuring every trial is delivered efficiently, and complaint to regulatory standards 

End-to-end agile clinical trial management, from strategy to close out

Expertise managing multisite Phase I–III trials

Strength in study planning, regulatory submission management, TMF oversight, and inspection readiness

For 40+ years, we have supported the efficient, and on time delivery of clinical trial with hands-on operational management

Project management co-located with clinical operations facilitating rapid communication and course correction if required

Our clinical project management services support a diverse range of clients, providing tailored guidance and operational support to meet unique development needs:

Startups

Early-stage companies needing structured guidance, regulatory alignment, and scalable operational support to run their first clinical studies, with flexible and agile project management.

Biotechs

Biotechnology organisations progressing through early to mid-phase development, requiring flexible project oversight, data driven decision support, and cross functional coordination.

Pharmaceutical Companies

Established pharma teams seeking experienced project managers to maintain consistency across complex, multi-country trials and ensure effective site, vendor, and stakeholder management.

What This Service Is

Our project management offering provides end-to-end oversight of clinical trials, ensuring every stage — from initial concept and protocol development through to final closeout — is delivered with precision, efficiency, and full regulatory compliance. We take a proactive, integrated approach, aligning strategy, operations, and execution to minimise risk, maintain timelines, and optimise study outcomes. By coordinating cross-functional teams and managing every operational detail, we enable sponsors to focus on scientific and commercial objectives with confidence. This includes:

  • Study strategy development and operational planning
  • Regulatory and ethics submissions, including liaison with authorities
  • Trial Master File setup, maintenance, and inspection readiness
  • Multisite coordination, investigator support, and site activation
  • Service Provider management, budgeting, timeline governance, and risk mitigation
  • Oversight of data management, monitoring, and quality compliance
  • Our teams integrate clinical operations, regulatory affairs, data management, recruitment laboratories, and biometrics to ensure cohesive delivery across all functions.
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Seamless Integration

Our project management function seamlessly integrates with all functions ensuring a unified and efficient approach for your clinical trial

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Our 6-Step Project Management Process

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1. Scoping & Onboarding

We align objectives, timelines, governance structures, and SOP requirements to create a unified project plan.

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2. Operational & Regulatory Set Up

Includes feasibility, site selection, investigator qualification, regulatory submission strategy, and essential document collection.

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3. Study Start Up & Site Activation

We streamline approvals, manage TMF documentation flow, and ensure inspection readiness.

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4. Execution & Oversight

Our project managers oversee monitoring, data collection, issue escalation, protocol compliance, and risk management.

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5. Communication & Reporting

We maintain transparent status reporting, milestone tracking, and communication pathways across sponsors, CRO partners, and internal teams.

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6. Close Out & Audit Preparation

Ensuring TMF completeness, data reconciliation, and regulatory ready documentation for submission.

Project Management

With extensive experience working as an integrated team across our sites, hVIVO's project management team have aligned SOPs and ways of working facilitating single and multi-site studies at all phases of the drug development spectrum. With a flat hierarchy and continuous access to all those involved in a study, from our leadership team down, there are no gaps in communication and execution. 

Core expertise

  • Study planning, feasibility, and protocol alignment

  • Global and local site management expertise

  • Budgeting, contract oversight, and service provider coordination

  • Agile governance structures, risk register, and mitigation plans

  • Clinical trial management system capabilities

We combine the strengths of a full-service CRO environment with hands on, flexible project management, offering distinct advantages for your clinical trials.

Proven Delivery

Over 40 years of operational excellence in delivering clinical trials.

Integrated Teams

Seamless cross-functional execution with integrated scientific, regulatory, operational, and data management, and biometrics teams. 

Robust Compliance

Unwavering commitment to ICH-GCP, UK Clinical Trial Regulations, and EU Clinical Trials Regulation, ensuring the highest level of quality and data integrity. 

Transparent Communications

Real-time reporting and transparent governance structures to keep you informed and in control. 

FAQ

Get in touch with us

Yes — our agile structures and hands on management allow efficient delivery even for complex, compressed timeline studies. 

Yes — we handle ethics and regulatory submission management, responses, and compliance oversight. 
Absolutely. Our teams specialise in European regulatory pathways and multi-country project management. 

Ready to Accelerate your Clinical Trial?

Contact us today to discuss your specific project management needs and discover how our expertise can drive your study to success.

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