Supporting Drug Development Across Every Stage & Sector

From early research to clinical proof-of-concept, hVIVO partners with pharma, biotech, CROs, start-ups, and investors to accelerate progress and de-risk development. 
Schedule a Call

Who We Work With

 

Whether you're a global pharma optimising early-phase timelines, an emerging biotech managing resource constraints, a CRO seeking predictable capacity, a start-up navigating first-in-human, or an investor evaluating therapeutic assets, hVIVO removes development bottlenecks with integrated clinical, laboratory, regulatory, and scientific expertise. We don't just execute—we partner with you to reach milestones with confidence.

Navigate early development with speed & strategic guidance

Challenges: Limited internal resources, regulatory uncertainty, and pressure to meet investor milestones.

What We Offer: Access to senior scientific and regulatory experts, high-quality laboratory and clinical infrastructure, investor-aligned programme design, and predictable timelines to support fundraising.

venn-team-seated
Explore Start-up Solutions

Flexible, expert-led support from lab to clinic

Challenges: Resource constraints and biomarker complexity slow progress toward clinical proof-of-concept.

What We Offer: Integrated assay development, translational consulting, human challenge trials, regulatory guidance, and scalable clinical delivery tailored to your stage and budget.

hVIVO_Scientific_Consultancy_Services
Explore Biotech Solutions

Accelerate clinical development with predictable execution

Challenge: Rising trial complexity, recruitment delays, and inconsistent CRO performance strain timelines.

What We Offer: Owned clinical sites, specialist populations, integrated teams, and peer-to-peer communication that delivers faster, more reliable early-phase data.

Nurse walking through corridor hvivo_jan25-297
Explore Pharma Solutions

Extend capabilities without disrupting client relationships

Challenge: Expanding capacity while protecting margins and maintaining operational consistency.

What We Offer: Partnership-based model as an extension of your delivery capability—owned sites, specialist populations, Phase I units, challenge infrastructure, and streamlined contracting.

hVIVO_Lab_Services_Sample_Analysis
Explore CRO Solutions

Rigorous due diligence & portfolio support from day one

Challenge: Assessing technical merit, regulatory risk, and development feasibility across diverse assets and stages.

What We Offer: Independent scientific, clinical, and regulatory due diligence; development strategy assessment; portfolio support; and exit/partnering readiness—so you invest with clarity and confidence.

investors-image

Why these sectors choose hVIVO

 

Whether you're a global pharma optimising early-phase timelines, an emerging biotech managing resource constraints, a CRO seeking predictable capacity, a start-up navigating first-in-human, or an investor evaluating therapeutic assets, hVIVO removes development bottlenecks with integrated clinical, laboratory, regulatory, and scientific expertise. We don't just execute—we partner with you to reach milestones with confidence. 

  • Deep expertise. Over 40 years of operational delivery across early-phase development, infectious disease, and clinical trials. Our teams bring practical, hands-on knowledge you can trust.
  • Integrated infrastructure. Owned clinical sites, specialist laboratories, regulatory specialists, and scientific consultants—all working together under one roof. No vendor fragmentation. No silos.
  • Quality & consistency. Accredited, audited facilities and validated processes mean predictable delivery, transparent communication, and transparent outcomes across every engagement.
  • Tailored partnership. Whether you need full end-to-end execution or targeted capability support, we flex to your needs, timeline, and budget. Flexibility built in.
hVIVO office shot

Integrated Drug Development

hVIVO offers world leading drug development services from preclinical consultancy through to Phase III clinical trials, including end-to-end human challenge trials services. With decades of experience in rapidly delivering data for our global client base, our team brings together strategic insight and operational expertise to deliver a variety of clinical study types across multiple locations.

To support rapid study start-up and reliable delivery, our dedicated recruitment teams in Germany and the UK provide direct access to both healthy volunteers and patient populations. This is complemented by our integrated drug development consultancy as well as our infectious disease and immunology laboratories and biobanking services. 

100k+

Integrated Drug Development

Over a century of combined experience in clinical research and infectious disease. Our heritage underpins the expertise and credibility we bring to every study.

5

Service, Reputation & Trust

Integrated capabilities across consultancy, clinical trials, laboratories, human challenge studies, and recruitment. Together, these services provide a seamless end-to-end development platform.

400k

Trial Participants Database

Access to one of the largest specialist volunteer databases in Europe. This enables rapid recruitment and high retention to keep studies on track.

1.9k

Trials Completed & Counting

A proven track record of successfully delivering a high volume of clinical trials across multiple phases and therapeutic areas. We focus on quality, efficiency, and reliable outcomes.

5

Clinical Sites

A network of purpose-built clinical research facilities across the UK and Germany. Designed to support efficient trial delivery, including complex and early-phase studies.

Trusted Across the Ecosystem

hVIVO works with these sectors because we understand their unique challenges. Our strength is the ability to bring rigorous science, operational excellence, and strategic insight to every stage of drug development

Schedule a Call

Pharma FAQs

More for Pharma

Faster than traditional networks. Our owned sites have guaranteed bed capacity, no dependency on third-party feasibility, and streamlined contracting templates. For straightforward Phase I studies, you're typically site-ready in 4-6 weeks. Complex studies or specialist populations may need longer, but we commit to predictable timelines upfront. 

That's exactly how many pharma partners work with us. We offer standalone components—recruitment, CPUs, Human Challenge Unit, lab services—or full end-to-end. You own the relationship with your teams; we extend your capacity where you need it.

Your team can visit sites, embed quality oversight, and receive transparent real-time reporting. We operate to your standards, not ours. 

Because we own our sites and maintain pre-screened cohorts, we have flexibility to adjust. We'll first work with you on protocol adjustments or population refinement. If timelines slip, we communicate immediately and adapt—no surprises. 
Yes. We have sites across the UK and can support EU expansion through our regulatory partners and network. We can also coordinate with third-party sites globally if needed, but our advantage is seamless delivery across our owned facilities. 

Biotech FAQs

More for Biotech

Earlier is better. Pre-IND is ideal—you get input on biomarker strategy, assay gaps, regulatory expectations, and trial design before spending time and money on the wrong path. But we work with biotechs at any stage, from discovery through Phase II. 

Yes. We offer modular engagement: targeted assay development, specific regulatory advice, or phase-by-phase support rather than full end-to-end contracts. Many emerging biotechs start with consulting, then layer in clinical delivery. We flex to your funding stage. 

That's our bread and butter. Our labs routinely develop and validate virology, immunology, and bioanalytical assays tailored to your MoA. We design assays for regulatory readiness from day one, so they're GCP-ready when you move to clinic. Timelines and costs are clear upfront.

We align programme design to value milestones that matter to investors: clear MoA proof, robust biomarker data, predictable timelines to IND/CTA, and GCP/GCLP-compliant outputs. We also help with due diligence prep and can support investor calls if needed. 
No. While infectious disease is a strength, we support all modalities: small molecules, biologics, cell/gene therapies, etc. Our Phase I CPU and translational labs work across cardio-metabolic, respiratory, women's health, and more. If you need specialist expertise we don't have in-house, we'll tell you upfront. 
Depends on your stage. If you have non-clinical data and a clear target, 6-9 months is realistic for IND-enabling work (CMC, tox, regulatory strategy, protocol). We run this in parallel, not sequentially. Get us involved early and we can map the exact timeline. 

CRO FAQs

More for CROs

We operate as an extension of your delivery team, not a competitor. You own the client relationship; we're a capability partner. Your name on the study. Your QA oversight. Streamlined contracting templates make it easy. We've done this for decades without relationship tensio 

That's when we add value. Specialist populations, Human Challenge models, custom assays, rapid feasibility—things that slow you down or require external subcontractors. We can say yes faster than you can coordinate vendors, and we integrate seamlessly into your study team. 

Shared. We commit to timelines and quality; you commit to clear protocols and reasonable timelines. If something changes, we adapt together. This isn't transactional—it's partnership-based. 

 We integrate into yours. Your QA team audits us the same way they audit third parties. We provide documentation, attend your meetings, and maintain transparent communication. You maintain full oversight. 
One component or full delivery. You choose. Some CROs use us for bed capacity only; others use our CPU and challenge capability. Mix and match based on what strengthens your proposal and timelines. 
Our templates are streamlined and partner-friendly. Most contracts move in 2-3 weeks. We don't have lengthy procurement cycles like traditional CROs.

Start Up FAQs

More for Start Ups

Before you've made major programme-defining decisions. If you're still deciding on biomarkers, assay strategy, or regulatory pathway, that's ideal. Early engagement prevents rework and ensures you're building on solid ground. Don't wait until you've committed to the wrong path. 

Yes. We offer flexible engagement models: regulatory consulting first, targeted assay work, or phased clinical delivery tied to fundraising milestones. Many early-stage teams start with 1-2 projects to build momentum before larger commitments. You don't need to do everything at once.

That's common. We assign a senior regulatory strategist to act as an extension of your team. You get continuous access to strategic guidance, IND/CTA planning, document authoring, and advice letter preparation. We'll keep you ahead of regulatory expectations, not scrambling to catch up.

We'll tell you honestly. Early diligence (sometimes called a "pre-IND assessment") can identify hidden risks—weak MOA assumptions, missing assays, unclear endpoints—before you've spent months and money. If there's a big problem, better to know now. 
Investors want high-quality data, predictable timelines, and evidence you've de-risked your programme. We help with all three: we design studies that generate investor-compelling data, we deliver on schedule (no surprises), and we produce documentation that passes investor due diligence. We can also participate in investor calls if it helps your story.
Just a clear picture of what you're building and where you are now. A brief executive summary, current data, and your goals for the next 12-18 months. We'll do a free initial consultation to understand your challenge, then propose next steps. No lengthy RFP required—we move fast. 
Both. Some start-ups work with us for 1-2 targeted projects; others partner with us for end-to-end guidance through IND and into early clinical. We flex based on your growth, funding, and needs. Many of our long-term start-up relationships started with a single consulting project. 

Contact Us