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Project Management

End-to-End Agile Trial Management and Oversight

Our Trial Management Services

We provide comprehensive, agile clinical trial management services designed to transform your clinical trial’s potential into measurable success. From small biotechnology firms to large global pharmaceutical companies, our experienced team offers customised support to advance your development plans.

  • Protocol Development and Feasibility Assessment
  • Site Selection and Evaluation
  • Budgeting and Cost Estimation and Management
  • Timeline development and oversight
  • Development of Project and Supportive Plans
  • Set up, Management, Inspection Readiness and Archiving
  • Strategic planning and management of Regulatory and Ethics Submissions
  • Regulatory Package development and oversight
  • Liason with Ethics Committee and Regulatory Authorities, including response management
  • Coordination of trial activities
  • Vendor Management
  • Risk Management
  • Collaboration with Data management teams to ensure accurate clinical trial data collection, validation, and compliance
  • Managing all aspects of Clinical Monitoring and Quality
  • Preparation for Site and study Audits, ensuring inspection readiness
  • Strategy Development and Implementation
  • Real-time Status Tracking and Transparent Reporting

Expert Project Management for Clinical Studies

Our team excels in managing complex clinical studies, leveraging data-driven approaches to expedite proof of concept and optimise clinical development outcomes. All studies adhere to ICH-GCP guidelines, with defined robust governance structures, clear communication pathways, and real-time progress tracking.

Global Trial Management with expert Local knowledge

Dedicated Oversight: Experienced Project Managers oversee every phase, from planning, execution, and close out; supported by risk-based strategies, issue escalation pathways, and documented milestone tracking

Work across clinical operations, data management, regulatory, and laboratory services to ensure cohesion among internal teams, sponsors, and CRO partners

Regular updates cover project status, risks, and actions, with documentation maintained in controlled systems, providing access to project, deviation logs, and data delivery schedules

Streamline startup processes, manage essential documents, and secure approvals to keep your trial moving

Site Management excellence, through support of investigator site identification, feasibility assessments, and activation processes

Regulatory Strategy and Compliance, to navigate regulatory landscapes

Service Models

Full-Service

hVIVO manages all operational functions, including feasibility, investigator identification, safety, monitoring, and more.

Project-Based

Ideal for short-term projects, enabling temporary collaboration with hVIVO.

Hybrid

Combines outsourcing with insourcing for flexible project support.

Embedded

Dedicated hVIVO professionals integrated within client processes.

Client Testimonials

Looking for real-time project oversight? Contact us to request a capabilities overview or download our factsheet.

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