Changing operations, processes and mindsets to ensure readiness is instilled into every aspect of a clinical trial, so all individuals involved in managing trials are prepared and ready to present complete and up-to-date data.
Ahead of this year’s Trial Master File & Inspection Readiness Forum, we spoke exclusively to Mihaela Nosca, Director Clinical Compliance and Inspection Readiness at CSL Seqirus, about the common pitfalls in preparing a healthy Trial Master File (TMF) ahead of inspections, top tips for overcoming these pitfalls and ensuring Good Clinical Practice (GCP), as well as how regulatory standards have changed since COVID-19 and the impact this has had on inspections.
Download the full interview now >>>
Please note: That all fields marked with an asterisk (*) are required.