Pistoia Alliance launches clinical data management toolkit

The not-for-profit Pistoia Alliance has launched a freely accessible toolkit to help companies implement principles for properly managing and sharing clinical data – something that is of vital importance as scientists, organisations and companies across the world look for treatments and vaccines for COVID-19. 

The toolkit aims to help life sciences organsations adopt FAIR (Findable, Accessible, Interoperable, Reusable) guiding principles for data management and stewardship. 

Funded by large pharmaceutical companies and SMEs including AstraZeneca, Bayer, Roche, Novartis, Bristol-Myers Squibb, AbbVie and Copyright Clearance Center, the Pistoia Alliance works to lower barriers to innovation in life sciences R&D. 

Collated by experts in the field, the toolkit contains numerous method tools, training and change management, as well as use cases, allowing organisations to learn from industry successes. 

As the life sciences industry continues to digitise, the not-for-profit hopes that FAIR guiding principles of Findable, Accessible, Interoperable and Reusable data will help companies realise their digital transformation and accelerate the application of  artificial intelligence (AI) and deep learning. 

Although organisations have become increasingly aware of data as an asset, the Pistoia Alliance is concerned that data are often siloed, stored in varying formats, and difficult to retrieve or share.  

It hopes that by adopting the FAIR principles companies will be able break down internal siloes and cope with the growing volume and complexity of data generated. 

The FAIR guiding principles were published in 2016 as a blueprint for well managed and machine-actionable data to allow computational systems to find, access, interoperate and reuse data with minimal human intervention. 

However, further research found that many companies are still struggling with implementation of the principles. 

The FAIR toolkit is available now and The Pistoia Alliance has worked with its industry partners to ensure that the toolkit remains compatible with other FAIR data standardisation projects. 

Dr Alexandra Grebe de Barron, IT business partner at Bayer, said: “The launch of the toolkit is coming at a time when life science companies are assessing how they store and manage data to meet new requirements and successfully embark on digital transformation projects. By collaborating with colleagues and partners, we can better realise the value of AI and advanced analytics.” 


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