Roche
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Universal Language: The Pistoia Alliance Takes on Indescribable Biology
Best Practices WinnerThe Pistoia Alliance has previously sponsored new methods for querying databases and the scientific literature, and a more effective algorithm for compressing and sharing genetic sequencing data. Over the past year, another Pistoia project, HELM, has entered the public domain after gradual development by an assortment of Alliance members. An open source language and set of editing tools for working with large biomolecules, HELM has already become a foundational part of research in at least three large pharmaceutical companies. Read More »
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CDISC for Medical Device Companies: Progress Made and Best Practices from Pharma/Biotech Implementation
The healthcare industry, as well as regulatory bodies, have been hard at work in the standardization of clinical trial data. The need for data transparency, traceability, and auditability has continued to increase, in line with the cost of studies and the amount of data submitted to the FDA. As a result, much progress has been made in the past decade in creating standards to ease data exchange and interoperability as well as speed up the regulatory review process.
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