Phase II-III Studies

 European Phase II & III Clinical Trial Services 
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Phase II-III Clinical Trial Services

Our integrated services provide end-to-end Phase II and III clinical trial support from study design and operational delivery to biometrics, data management and regulatory alignment accelerating your drug development efficiently and reliably.

  • Recognised leaders in infectious disease, cardiometabolic and respiratory disease Phase II/III studies with state-of-the-art UK and German sites.
  • Outpatient sites in Germany can accommodate 200 outpatient visits per day, with deep experience with Diabetes, Obesity, Metabolic Disorders and Cardiovascular Disease.
  • UK sites accommodate studies from large scale vaccine trials to outpatient studies.
  • Over 25 years’ experience delivering multiphase clinical trials with hands-on, high quality execution.
  • Robust participant recruitment supported by large volunteer databases with characterised patients.
  • Full drug development consultancy and trial management across all phases, from non-clinical, through to phase III.
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For Biotech, Pharmaceutical, and CRO

Biotech

Access to European wide trial capabilities, complex cohort management, and disease area expertise across infectious disease respiratory, cardiometabolic and more.

 

Pharmaceutical

Scalable, multisite Phase II–III programme delivery with strong regulatory alignment and biometrics support across the full development lifecycle.

CRO

Lean on our sites in the UK and Germany for trial delivery.  

Expert led Phase II and III clinical trial delivery

Through our purpose-built facilities hVIVO runs single site or multi-site  Phase II and III studies in both UK and Germany. With specialisms in cardiometabolic, respiratory and infectious diseases hVIVO supports sponsors to deliver the data they require to reach their milestones. With key opinion leaders in our core specialisms and medical teams dedicated to clinical research our expert teams help accelerate study deadlines through their depth of experience and knowledge.
    • Expert-led trial design and consultancy
    • End-to-end trial execution with European wide infrastructure
    • Specialised infectious/respiratory facilities, including spirometry, lung function tests and bronchial challenge assessments.
    • Specialised Cardiometabolic assessments covering glycaemic control, lipid metabolism, energy expenditure, cardiovascular–metabolic interplay, and advanced liver health biomarker assessment to support robust Phase II/III clinical development.
    • Our well characterised recruitment database, along with our strong links to Primary Care networks, support accelerated timelines for study start up

From study design and regulatory planning - to site execution across our UK/EU clinics

Study Design & Consultancy

Define study endpoints, protocols and statistical frameworks with expert input.

Operational Planning

Site selection, regulatory planning and participant recruitment strategies leveraging robust volunteer databases.  

Clinical Execution

Conduct inpatient/outpatient visits across our owned UK and EU sites. 

Data Management & Biometrics

Regulatory compliant data capture, analysis and reporting to support submissions.

Laboratory

High quality sample processing, biomarker assessment and analytical support to support regulatory compliant data  

Study Close out & Reporting

Integrated reporting, insights and regulatory documentation to advance studies to the next phase.

Patient Populations

Our team includes trial designers, respiratory specialists, clinical operations experts, data managers, and statisticians with decades of combined experience across European clinical research. 
Vaccines_bright_green

Diabetes

Comprehensive understanding of glycaemic control, insulin resistance, glucose metabolism and patient compliance 

Healthy Volunteers_bright_green

Metabolic Disorders

Expertise in lipid metabolism, energy expenditure and complex biochemical pathways supporting targeted therapy development.

Cardiovascular Disease_bright_green

Cardiometabolic Research

Integration of cardiovascular, obesity and metabolic disorder expertise to improve Phase II/III cardiometabolic trial outcomes.

Samples Annual Processing Capacity_bright_green

MAFLD & MASH

Advanced capabilities in assessing disease progression identifying biomarkers and evaluating liver health interventions.

 

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Respiratory

Advanced respiratory assessments for Asthma and COPD patient populations

Inflammation Immunology_bright_green

Infectious Diseases

Dedicated human quarantine facility, with integrated laboratory for infectious diseases studies

Case Study - Delivering Large Scale Outpatient Vaccine Trials

1100+

Participants Screened

Over 1,100 participants were efficiently screened through our dedicated outpatient facility, ensuring a high-quality and eligible cohort within tight timelines. 

817

Participants Dosed

We successfully dosed 817 participants, demonstrating our ability to deliver large-scale outpatient trials with precision and consistency. 

6 Week

Period Recruitment

Rapid recruitment was achieved within just six weeks, leveraging our established database and streamlined screening processes. 

Sole UK

Site Selected by Client

Selected as the sole UK site, reflecting strong confidence in our capabilities to deliver complex vaccine trials at scale. 

Discover More from hVIVO

Research Units

With 5 clinical research units based in the UK and Germany, hVIVO has the ability to run integrated clinical trial delivery as a single site or as multiple sites from Phase I-III and post-marketing. 

hVIVO Screening Area
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Recruitment

Dedicated in-house recruitment team with an active participant database of +400,000 to accelerate study start up times

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Data Management

Wrap around services include data management & biostats 

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Project Management

Project management excellence 

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Therapeutic Areas

hVIVO has deep therapeutic area knowledge and expertise in infectious diseases, respiratory, cardiometabolic disease - discover more here

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Renal and Hepatic Impairment

With access to specialist populations through longstanding and reciprocal relationships with primary and secondary care, hVIVO has a dedicated unit for PK studies in those with renal and hepatic impairment as well as other specialist populations. Find out more how we can support Biotechs, Pharma and CROs and accelerate their drug development pipeline
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FAQ

Get in touch with us

Yes. UK and German facilities support both inpatient and high throughput outpatient activities.

 Yes. Full data lifecycle management, statistics and methodology support are available.  

Our clinical sites are in the UK and Germany

Infectious diseases, respiratory conditions, cardiometabolic diseases, metabolic disorders, renal/hepatic impairment and more.

Ready to collaborate? Contact us to find out how we can support your Phase II/III clinical trials.

Enquire now

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