Francesco Bedani

Director, Clinical Vaccines Management & Bioassays and Samples Management @CSL

Responsible of clinical supply chain,(clinical demand, IMP prodution and allocation to studies, placebo preparation, comparator sourcing, storage, distribution, final accountability, return and destruction). Accountable for efficient resource and budget planning in CVM, including monitoring of costs and developing forecasts. Responsible to ensure an adequate IRT/IVRS system is set up is maintained for all studies, which includes its development, maintenance and respective interfaces to other e-clinical systems. Plan and implement appropriate randomization procedures and blinding measures. Responsible for vendor management of all CVM vendors. This includes contract negotiations, oversight of contract adherence, establishment and regular review of key performance indicators (KPIs), regular business review meetings and a global supply vendor strategy. Responsible to ensure in-time supply to clinical sites in compliance with international guidelines and company SOPs. Ensure drug labelling is correct according to specifications and in compliance with respective regulations determined by international and local standards and requirements Responsible for efficient, cost-effective and compliant of serology clinical trial sample collection, storage, transportation and archiving. Oversee planning and forecasting for serology sample collection, analysis and storage Accountable for driving ongoing continuous improvements for Clinical Supply and Serology part. Responsible for maintenance and coordinated revision of Standard Operating Procedures as appropriate to ensure ongoing compliance and the efficient conduct of CVM activities.