Traditionally, a trial master file (TMF) has been thought of as a collection of documents to be collated to satisfy the regulatory requirements of a clinical study. While this is still the case, today’s increasing use of electronic TMFs and integrated clinical systems is giving the industry a more holistic and real-time view of clinical trial activities.

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The pharmaceutical industry is undergoing a huge transformation. The traditional ways of clinical research will soon be a thing of the past, with disruptive technologies like machine learning (ML), artificial intelligence (AI), natural language processing (NLP) and robotic process automation (RPA) moving from niche positions to sweep across the pre-clinical and clinical research value chains

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The life sciences industry today is undergoing a wave of disruption, with biopharmaceutical companies embracing potential new ways to deliver a value-based model over volume by developing specialty products in target segments.

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The journey so far

Year 2017 was a learning phase for the Medical Device industry. With the official launch of the European Medical Device Regulations (EU MDR 2017/745) and European In-Vitro Diagnostic Regulations (EU IVDR 2017/746), many medical device and in-vitro diagnostic companies faced uncertainty and confusion over the new requirements, as well as risks and challenges to their business.

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Although high-profile data breaches grab the headlines, behind the scenes, life sciences is just as information sensitive as any industry. Any pharma company faces a major challenge when it comes to complying with the myriad regulatory requirements about how they create, handle and submit documentation about the products they manufacture.

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