Clinical Development

 End-to-End Early Phase through to Phase III Clinical  
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Clinical Development

hVIVO is the global leader in human challenge clinical trials and a full-service early-phase CRO. Through our UK quarantine facilities and European clinical research units located in Mannheim, Kiel and Berlin (154 beds), hVIVO delivers Phase I–III capabilities.

Through our integrated virology, immunology, molecular, bacteriology labs, drug development consultancy, Phase I-III sites and clinical operations along the with a large database of participants sponsors benefit from a unique portfolio of services with world-leading scientists and medical experts lending their knowledge and experience from the outset. hVIVO delivers early insights to late phase execution.

Our Expertise

  • World leader in human challenge trials with a unique portfolio across infectious & respiratory indications
  • Specialists in cardiometabolic, infectious disease, respiratory, dermatology, and special populations
  • Flexible capacity: UK quarantine unit with 50 + inpatient beds and outpatient facilities. Separate London based outpatient facility specialising in Phase II/III studies. Germany early-phase Clinical pharmacology units totalling 154 beds with large outpatient facilities supporting phase II/III studies
  • End-to-end services: Study design through to clinical delivery from Phase I (FiH, SAD/MAD), PoC, Phase II/III, integrated labs, biometrics, medical monitoring, regulatory and recruitment
  • Database of 400K+ participants including specialist populations such as those with renal and hepatic impairment
  • Programme support from pre-clinical through Phase III trials
German site _patient in clinic with staff_Copyright by Julia Berlin_RAW__Y6A6377

Core Services

Clinical Pharmacology Early Phase

Dedicated clinical pharmacology units specialising in First-in-Human, SAD/MAD, pharmacology studies, Phase II PoC, BE/BA, QTc, food effect and DDI studies. Our teams are highly experienced in running umbrella studies accelerating timelines to PoC considerably. 

Phase I Clinical Research Units

Move from first-in-human (FiH) to proof-of-concept (PoC) with an integrated, safety‑first early phase programme. Our German & UK sites combine inpatient capacity, specialist laboratories, and large volunteer databases to deliver fast, decision‑ready data. 

Phase II/III Clinical Research Units

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. 

Data Management

End-to-end clinical data management and biostatistics ensuring accuracy, compliance, and high quality insights across all phases of drug development.  

Medical Monitoring

Real time medical monitoring driven by medical insight. hVIVO medical monitors are highly experienced in clinical trial research backed by extensive clinical practice in healthcare settings. Combining this experience provides sponsors the support they require for independent medical monitoring.

Medical Writing

Our medical writing services support every stage of clinical development, delivering clear, accurate, and regulatory-compliant documentation from early-phase studies to full submissions.  

Project Management

Drive your clinical trials to success with our expert clinical trial project management. We offer end-to-end support for Phase I-III studies.  

Quality Assurance

hVIVO runs a regulatory compliant Quality Management System (QMS) spanning clinical, laboratory, data and project operations, with risk based internal audits, service provider (vendor) assessments, quality incidents management and Root cause Analysis (RCA), CAPA oversight, and inspection support aligned to regulatory expectations (MHRA, EMA and FDA).

Recruitment & Site Solutions

Qualified sites, specialist populations & expedited feasibility/contracting​. Our sites are all hVIVO owned providing sponsors with the knowledge and confidence that studies will be run to our exacting standards. SOPs are aligned across all sites allowing for seamless single and multi-site studies.

Regulatory Affairs

End to end regulatory affairs services: regulatory operations, submissions and package writing from CTA/IND and beyond. 

Clinical Trial Sites

With 5 clinical research units owned and operated by hVIVO, providing services from FiH onwards, hVIVO can support sponsors at all phases of drug development through single site or multi-site trials. 

Biostatistics

Our integrated Biostatistics service ensures rigorous planning and execution of the statistical analyses to answer the clinical question of interest.

hVIVO Mannheim is now CIR accredited

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Our Other Accreditations

Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard; for designing, conducting, recording and reporting trials. Ensuring participant safety prevails over the interests of science and society.

 

HVIVO-ACCREDITATION-MHRA

 

Human Tissue Authority (HTA)

hVIVO is accredited by the Human Tissue Authority (HTA), meaning that we have been recognized by the HTA as compliant with standards and regulations for the ethical and legal removal, storage, and use of human tissue. A HTA license is essential, as hVIVO handles human tissue for various research purposes.

 

HVIVO-ACCREDITATION-HTA

 

Good Clinical Laboratory Practice (GCLP)

 All clinical trials comply with GCP and/or GCP for Laboratories (GCLP) guidance. Human Challenge Agent-only clinical studies that do not involve IMP also comply with GCP/GCLP. 

 

HVIVO-ACCREDITATION-MHRA

 

College of American Pathologists (CAP)

 The CAP laboratory accreditation programme ultimately recognises laboratory quality and compliance. CAP accreditation is globally recognised, and provides assurance the hVIVO laboratory services are able to be delivered to a standard. 

 

HVIVO-ACCREDITATION-CAP

 

UKAS ISO/IEC 17025:2017 Accreditation

HVIVO-ACCREDITATION-HVIVO

 

FAQ

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hVIVO delivers a full suite of early clinical services including Phase I studies, first‑in‑human research, clinical pharmacology, early patient studies, human challenge trials, data management, biostatistics, and regulatory support. Our integrated model combines clinical sites, laboratories, and scientific consulting to accelerate decision‑making and reduce the time to key milestones.
Because we operate owned clinics, specialised laboratories, in‑house scientific experts, and established regulatory pathways, hVIVO eliminates common handoff delays found in traditional CRO models. This end‑to‑end approach streamlines planning, study delivery, data analysis, and regulatory preparation — allowing sponsors to reach proof‑of‑concept faster

Plan your next Clinical Trial with hVIVO

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