Phase I & Early Phase Clinical Trial Units

End-to-end early phase trial execution 
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Phase I & Early Phase Clinical Trials

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.

  • 7,000 + Early Phase trials delivered the past five years
  • 94 inpatient beds in Mannheim, 18 in Berlin and 26 in Kiel to support complex early phase designs
  • 400,000 + participants in our group‑wide database across healthy and patient populations to rapidly enroll subjects
  • Advanced Metabolic investigations led by world-leaders in cardiometabolic disease
  • Advanced renal and Hepatic Impairment investigations with direct access to Hepatology and Nephrology University Hospital networks
  • Special and patient populations
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ICON_Human Challenge Trials

For Biotech

For start-ups and biotech's, de‑risk mechanisms of action quickly with adaptive early designs, delivered by experienced medical and clinical teams supported by our consultancy teams 

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For Emerging Pharma

Compress timelines with integrated SAD/MAD, food‑effect and PoC options under one protocol

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For Global Pharma

Add specialist capacity for complex PK/PD, DDI, Pharmacogenetic studies, biosimilar, vaccines  and respiratory studies and renal and hepatic impaired populations across UK and Germany

Plan your Early Phase Clinical Trial with hVIVO

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Expert Design & Study Conduct

Feasibility & Design

Therapeutic review, translational assumptions, and dose‑selection using PK/PD modelling. Our consultants optimise designs for BA/BE, DDI and complex multi‑part studies and protocol design.

Start‑Up & Governance

End‑to‑end regulatory and ethics support (CTA/IND packages, risk mitigation per EMA guidance), vendor set‑up, and database build for rapid first‑patient‑in.  

First‑in‑Human Delivery

 Sentinel dosing and staggered cohorts with intensive safety monitoring, telemetry, and real‑time lab readouts 

Decision & Transition

Locked, analysis‑ready datasets, biostatistics and medical writing enable go/no‑go decisions and smooth progression into subsequent phases.

 

Input from our PK/PD biometry analysts and consultants provides valuable insights to facilitate informed decision making during and following studies

Study Types

  • First‑in‑Human (FIH)
  • Single/Multiple Ascending Dose (SAD/MAD) including umbrella/Integrated protocols
  • Bioavailability/Bioequivalence (BA/BE)
  • Proof-of-Concept (PoC)
  • Drug–drug and food‑effect studies
  • QT/QTc assessments
  • Vaccine studies
  • Pharmacogenetic
  • Biosimilar

Clinical Pharmacology

 Our Clinical Pharmacology services deliver end-to-end early phase trial execution—from First in Human to Phase Proof of Concept (PoC)—supported by deep therapeutic expertise, specialist facilities, and a proven track record across complex study designs, and special population cohorts such as renal and hepatic impaired participants  

Special Population and Patient Experience

Special Populations

  • Elderly  

  • Pharmacogenetic Normal, Intermediate, Excessive Metabolisers  

  • Gender Trials (female, post-menopausal)   

  • Renal Impairment  

  • Hepatic Impairment  

Patient Populations

  • Diabetic 

  • Obese 

  • Women’s Health (PCO, Endometriosis)  

  • Dermatology (Atopic dermatitis, Psoriasis) 

  • Hypertension  

  • Hypercholesterolemia 

Clinical Research Units

Mannheim Groupes Action & Building 38

Germany - Mannheim

Inpatient features:

  • 94 beds (58 long‑term)
  • Three wards and large outpatient facility
  • Study types include, First-in-Human, QTc, narcotics/opioids, DDI/FDI, BE/BA
  • On-site pharmacy
  • Cardiometabolic focus
Kiel Clinical Research Unit

Germany - Kiel

Inpatient features:

  • 26 beds (20 high‑care)
  • Dedicated to renal/hepatic impairment and elderly populations
  • Continuous monitoring
  • On‑site pharmacy and lab processing
Mannheim Groupes Action & Building 135

Germany - Berlin

Inpatient features:

  • 26 beds (18 intensive monitoring)
  • Specialised in women’s health

Meet Our Early Phase Experts

FAQ

Get in touch with us

The first administration of an investigational medicinal product to humans, typically focused on safety, tolerability and PK/PD characterisation, often using SAD/MAD designs. 

 

We apply EMA guidance on identifying and mitigating risk, using staged progression, sentinel dosing and predefined stopping rules, supported by real‑time data review. With close proximity to hospitals in case of emergencies.

In patient capacity includes Germany Mannheim and Kiel, with a preferred CRS partner site in Berlin with integrated labs and on‑site pharmacies to streamline operations

Plan your next Clinical Trial with hVIVO

If you're a potential customer, find out how hVIVO can help you.

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