Integrated Clinical Trial Delivery Phase I-II

hVIVO delivers fully integrated clinical trial services from protocol design to Phase III programmes, including regulatory support, data management, monitoring, PK/TK & PD, CMC consulting, and analytical lab support across Phases I-II

 

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End to End Integrated Clinical Trial Delivery

Our integrated service offering combines protocol design, regulatory preparation, trial execution, operational oversight, data management, biostatistics, PK/TK analysis, CMC guidance, and analytical laboratory support. Sponsors benefit from a single, unified operating model that eliminates fragmentation and accelerates decision‑making.

  • 35+ years’ experience in early development and clinical operations
  • Integrated data, regulatory, lab, and clinical teams
  • Proven IND → Phase II delivery support
  • Trusted by biotech and pharma
  • Faster execution enabled by agile governance & rapid project start‑up
Mannheim Groupes Action & Building 131

Reasons to Choose hVIVO

Integrated Team

Clinical, regulatory, medical writing, biostatistics, data management, and laboratory  

Scalable

Resources aligned to timelines and portfolio needs 

Budget & Vendor Management Ease

Budget aligned delivery, with all services under one MSA

Therapeutic Expertise

Specialist expertise in infectious disease, respiratory, cardiometabolic, and vaccine development

Dependable

Proven track record with biopharma

Regulatory

Full regulatory and UK/EU legal representation for sponsors

Included in hVIVO’s Integrated Clinical Trial Delivery Solution

Trial Design & Regulatory:

 Protocol design, Regulatory writing & submissions, CMC consulting

Execution & Oversight:

Clinical trial delivery, Monitoring, Project management

Data & Analysis:

 Data management, Biostatistics, PK/TK & PD analysis  

Support Services:

Medical writing, Legal support (UK/EU representation), Analytical/virology/immunology lab

FAQs

 Yes, with integrated operations, regulatory, data, and lab support. 

 Yes, we provide required local legal representation. 

Yes, bolt‑on services are available under the same MSA enabling faster decision making and delivery.

Yes, all under one integrated framework.

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