Introduction
A small sized pharmaceutical company, who had already performed proof-of-concept studies with a small molecule drug candidate came to Venn Life Sciences with the aim to bring their product into clinic as soon as possible.
Challenges
The company’s first objective was to run a clinical study as soon as possible; however they did not have the knowledge or expertise on what requirements were needed in terms of safety information for a phase I clinical trial. Their second objective was to have support in all regulatory documentation (IND modules, IB), which needed to be written prior to the study & needed to be accurate, to avoid any delays to their clinical study.
Solution
This client required the expertise and attention of the Venn Life Sciences team, consisting of CMC, non-clinical and clinical consultants. As a first step, a Drug Development Plan (DDP) was written for which experts of all teams contributed. The DDP provided a plan for all the requirements needed in order to start the clinical study, including an estimation of costs and timelines.
hVIVO plc (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.
