Transmogrified external environments, evolving regulations and internal process improvement strategies have caused the clinical trial industry to adapt and evolve its processes, and the stakeholders involved. More and more, clinical trial sponsors are looking to collaborate with clinical research organisations (CROs) that they can trust, work functionally with their current needs and structures, and provide the results needed.

Ahead of this year’s Trial Master File & Inspection Readiness Forum we spoke exclusively to Tatjana Jevtovic, Associate Director, TMF Operations Quality at Worldwide Clinical Trials about how to develop successful relationships with your sponsors to ensure successful, complete and prepared clinical trial operations for bio-tech and pharmaceutical companies in an ever-changing world.

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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.

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If you were handed with a notice for a clinical trial inspection plan right now, how would you react? - With a feeling of asserted confidence or a rush of slight concern? Wherever you think you would stand on this spectrum, use this interactive infographic to learn from your peers’ mistakes.

Pharma IQ invites the expertise of Andy Fisher Senior GCP Inspector MHRA on a list of common TMF failings. Alongside a number of other EU member states, Andy was recently involved in drafting guidance that the EMA is due to publish shortly. This draft guidance for TMF will replace what is currently in volume 10.