PK Consultant Knowledge of Trials case study

Venn Life Sciences was requested to perform the non-compartmental pharmacokinetic analysis (NCA) for an oncology trial for a bispecific antibody. For this trial, strict timelines were set to meet the regulatory deadlines, however due to setbacks in the trial conduct/analysis the critical timelines were at risk. Venn Life Sciences was approached on the advice of the client’s biotech partner as the client was informed that Venn would assist in accelerating the analysis and de-risking the submission timelines.

In addition to the NCA analysis, Venn Life Sciences was also requested to deliver the pharmacodynamic and immunogenicity analysis for this trial within the same strict 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.

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