With over 35 years of expertise in clinical trial management, hVIVO delivers comprehensive and agile project management services tailored to transform your clinical trial’s potential into measurable success. From small biotechnology startups to large global pharmaceutical companies, our seasoned project management team provides customized support to advance your development plans and ensure successful outcomes.
We offer full-service trial management, guiding you seamlessly from feasibility and strategy development through recruitment, setup, execution, and close-out while expertly navigating the complexities of the global regulatory landscape. Additionally, we provide standalone services at any stage of the product development lifecycle and can embed dedicated project managers within your teams who are fully integrated with your processes for maximum efficiency.
years of experience in clinical trial management
hVIVO takes full responsibility for managing the entire operational functions of your clinical study, including feasibility, investigator identification, clinical operations, data and safety monitoring, pharmacovigilance, data management, statistics, and quality assurance, etc.
Assistance for specific, short-term projects or trials, enabling collaboration between the client and hVIVO on a temporary basis.
A combination of in-house services and 3rd party vendor management.
Dedicated hVIVO professionals integrated within client processes.
We streamline study start-up activities, develop and manage essential documents, and secure approvals to keep your trial moving on track and on budget.
Our experienced project management team can assist with feasibility assessments, protocol development (including medical writing services), site evaluation and selection, budget estimations and management, regulatory authority and ethics committee interactions, timeline development, and the development of management plans (e.g., project, data management, pharmacy, and laboratory management plans) to ensure the smooth operation of your study.
Our team can assist you to set up and manage your trial master file, ensuring compliance with Good Clinical Practice, and helping you prepare for audits and inspections.
Our project management team offers strategic planning and oversight of regulatory submission documents, including the development and coordination of the complete regulatory package. We ensure your study remains fully compliant with both global and local regulations and guidelines.
We are experienced in liaising with ethics committees and regulatory authorities in the UK, EU and US, helping our clients gain the necessary approvals.
Having successfully managed the operation of more than 80 clinical trials, hVIVO can deliver seamless project management tailored to your goals. Our clinical trial sites can execute Phase I to III studies, coordinated by our dedicated and agile project management team. We excel in risk management, ensuring participant safety is prioritised, high-quality data is collected, and your project milestones are met within budget and on time.
As well as our full-service offering, we can optimise the selection, activation, and management of external clinical trial sites and manage any 3rd party vendors, such as laboratories.
Collaboration with our data management and study monitoring teams ensures accurate and compliant clinical trial data collection and validation. Our teams can manage all quality and monitoring aspects of the clinical trial, including preparation and readiness for site and study audits.
Our team provides expedient and accurate project tracking and reporting to keep sponsors informed and allow projects to remain agile.
hVIVO specializes in the management of early-phase clinical trials, from Phase I (first-in-human) through to Phase IIa. We operate the world’s largest human challenge clinical trial unit, accelerating vaccine and antiviral development for our clients. Our team also has deep expertise in conducting complex pharmacokinetic and pharmacodynamic studies, including those involving participants with renal or hepatic impairment.
We are also experienced in managing field studies and global multi-site trials. Supported by expert local knowledge and close collaboration with investigator sites and competent authorities, we leverage data-driven strategies to accelerate proof of concept and enhance clinical development outcomes.
World's largest human challenge clinical trial unit
Excel in managing early phase clinical trials
Experienced in managing field studies & global multi-site trials
Accelerate proof of concept
Our purpose-built customer relationship management (CRM) system and established recruitment and retention strategies can be tailored to efficiently find participants for your study and reduce the risk of dropouts.
Clinical Trial Sites
Our clinical trial sites in the UK and EU provide access to a huge potential participant population.
Potential participants in our database
Participants a week can be screened
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