Clinical Project Management
Our expert Clinical Project Managers have international experience in guiding organisations through the early stage of the product development journey and are specialised in early-phase clinical trials, including First-in-Human trials. By acting as a sponsor representative in clinical site or vendor selection and oversight – from set-up to trial close-out, managing all aspects of the clinical trial, such as timelines, risks, reporting requirements, and budget – we guarantee a seamless trial execution.
At Venn, we build a unique team of site and vendors for each project based on the requirements of the protocol or any specific needs of the compound. This, combined with priority given to quality and Good Clinical Practice (GCP), offers an integrated approach to ensure efficient coordination of your clinical trial.
Biosample Operations Management
Our dedicated biosample operations project management service offering ensures the global coordination and logistics of human biosamples collected in clinical trials with the objective to obtain reliable biosamples and deliver valid results. We cover biosamples of phase I-IV trials for various analytical purposes, i.e., pharmacokinetic samples (PK, anti-drug antibodies, neutralising anti-drug antibodies), biomarker samples, and in biobanks.
Our Project Managers take full responsibility of biosample logistics, which includes biosample-related records. We ensure efficient coordination and integrity of your biosamples to get the most value data while complying with regulatory requirements and GCP.
Biomarker Analysis Management
Our Project Managers in Biomarker Analysis support drug development programs by setting up and monitoring external biomarker analysis within clinical trials. Our objective is to achieve comprehensive, high-quality biomarker data sets that are used to generate new information about the drug concept and drug activity, and to finally support data driven decision-making in clinical programs with high quality and compliance with regards to outsourced biomarker analysis.
Our dedicated Project Managers supervise and manage business interactions with providers of external biomarker measurements including contracting and budgeting. We ensure conduct of your outsourced biomarker measurements in compliance with scientific, technological, and regulatory requirements.
Biosample Operations
Biomarker Analysis