Venn Life Sciences, part of the hVIVO plc, is an Integrated Drug/ATMP Development Partner offering a unique combination of pre-clinical/CMC development expertise, clinical trial design and management. That enables to create, plan, and execute the development programs effectively and seamlessly for the clients.

Venn provides data-centric End-to-End Trial Support, providing data driven trial design and methodology. The Service Sheet describes where Venn designed a single seamless phase II/III adaptive pivotal study, supporting the marketing authorisation application for a product in a high unmet medical need in a pediatric indication.

For over 25 years, the clinical pharmacokinetic (PK) and pharmacodynamic (PD) team of Venn Life Sciences have supported (model-independent) noncompartmental (NCA) PK and PD analyses for top ten pharmaceutical companies.

The CMC regulatory team has 20+ years’ experience supporting several pharma (small and large molecules) and medical device companies to ensure the continual manufacture and supply of high quality products to patients in licenced global markets.

Small dedicated team of Senior Medical Writers and Clinical Trial Assistant with total team experience in clinical and regulatory writing of more than 75 years.

Venn clinical trial management group has the expertise to set-up, coordinate and deliver clinical trials including vendor selection, investigational product logistics, data management, safety analyses, reporting, and clinical monitoring. We have experience with chemical entities, vaccines, and generic compounds.

For 20+ years, members of the CMC (Chemistry Manufacturing and Control) team have supported and are supporting numerous pharmaceutical companies to ensure the timely development and manufacture of high-quality drug substances and drug products for non-clinical- and clinical studies.

Non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic/toxicokinetic (PK/TK) characteristics of drug candidates. If performed well, it can identify key ‘knock-out’ criteria early, maximizing the chances of success in subsequent clinical development.