Large Pharmaceutical Support

Partner with our owned clinical sites, specialist populations, Clinical Pharmacology Units, and Human Challenge Unit to deliver fast, predictable early‑phase studies.

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hVIVO PK Consultancy Team

Accelerate clinical development with hVIVO. We help large pharmaceutical organisations overcome rising trial complexity, recruitment delays, regulatory burden, and CRO performance challenges — delivering faster, predictable early human data.

Large pharmaceutical organisations face increasing operational pressure: more complex protocols, inconsistent global CRO performance, constrained site capacity, and widening regulatory variation. hVIVO removes these bottlenecks by delivering predictable early‑phase execution, specialised services including human challenge model development and trial delivery and faster early human data to support informed portfolio decisions.  

 

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Your Challenges

  • 70% of site staff report trials have become significantly harder to manage.

  • Recruitment and retention remain the number‑one challenge for 72% of sponsors.

  • Sponsors cite inconsistent CRO speed, technology maturity, and quality.

  • Clinical operation leaders face pressure to deliver faster with limited internal capacity.

 

 


 

 

How hVIVO Helps Large Pharma Accelerate Development

  • Predictable Recruitment & Faster Timelines

  • Cohorts of pre‑screened & characterised participants

  • Controlled inpatient environments for reliable cohort delivery

  • Outpatient facilities with dedicated trained staff to support Phase II/III trials

  • Access to renal and hepatic‑impaired cohorts and pharmacogenetic profiles for clinical pharmacology studies 

 Consistent Quality & Communication  

  • Peer‑to‑peer communication

  • Integrated medical, clinical operations, lab, and scientific teams

  • Owned sites enabling operational standardisation and predictable capacity


hVIVO Core Capabilities for Pharmaceutical

Early‑Phase Clinical Research

Clinical Pharmacology Units 

 Study types - FIH, SAD/MAD, Phase I/II

Human Challenge Trials

 Including, model development, viral manufacturing, controlled exposure and clinical operations  

Laboratory Services

 

Virology, immunology, molecular, and bacteriology

Site and Recruitment Solutions

Qualified sites, expedited feasibility and contracting, and specialist populations  

Agile support to expand studies in Europe

Our site network and regulatory support for IND to IMPD transfer , enables you to contract with one CRO to run your European studies.  

Considering an Acquisition, Licensing Deal, or New Partnership?

Before you commit clinical or capital resources to a new asset, our Due Diligence & Gap Analysis team gives you an independent view of the risk:

  • Independent, cross-functional risk assessments of drug development assets — supporting confident investment, licensing, or acquisition decisions
  • 80+ due diligence projects delivered (150+ including gap analysis), across small molecules, biologics, ADCs, ATMPs, and combination products
  • Full evaluations completed in as little as two weeks, built to match deal timelines rather than slow them down
  • Scientific, CMC, nonclinical, clinical, and regulatory risk assessed by one cross-functional team, not a patchwork of external consultants
  • In-licensing due diligence work that's led to expanded, ongoing partnerships with global pharma teams
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Explore Due Diligence Services

Get an independent, cross-functional risk assessment before you commit clinical or capital resources — see how our due diligence and gap analysis team can help.

Due Diligence Services

FAQs

Get in touch with us
Owning and operating all our clinical sites gives hVIVO full control over capacity, staffing, processes, and quality. This standardisation enables faster, more predictable delivery and reduces operational risk. Combined with access to pre‑screened, phenotype volunteer cohorts, our owned-site model improves recruitment speed, data consistency, and overall study reliability.
We operate five dedicated clinical and laboratory facilities across the UK, purpose-built for Phase I and human challenge studies, early clinical research, and specialist laboratory support.


 

 We maintain access to targeted early phase cohorts, including renally impaired and hepatically impaired volunteers. These specialist populations allow CROs to deliver more complex studies efficiently and without lengthy site feasibility delays. 

 Infectious disease, respiratory, cardio-metabolic.

 Yes. We can provide specific components (e.g., specialist populations, Clinical Pharmacology Unit delivery, challenge studies) or full end-to-end execution — depending on what the CRO needs to strengthen its proposal and delivery.  

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