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Pistoia Alliance Publishes Free Guide to Accelerate the Implementation of FAIR Principles in Clinical Data

Boston, 25 January 2023, The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D today launched its freely accessible FAIR4Clin guide. The guide will help clinical regulators, biopharmaceutical and healthcare organizations to implement the FAIR principles (Findable, Accessible, Interoperable, Reusable) in clinical datasets. The diversity of data types, standards, and regulatory and privacy requirements, combined with the huge volume of clinical datasets, has presented a particular problem in life sciences R&D. The guide emphasizes the value of FAIR to the clinical space, including making data machine-readable to support AI, innovating in clinical trial design, and enabling the transfer of data between sponsors, CROs, and regulatory agencies. FAIR4Clin was co-authored by the Pistoia Alliance and leading experts in the field, including from AstraZeneca, Bayer, Roche, Genentech, Galapagos, The Hyve, Elixir, The University of Manchester and Oxford University.
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Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
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