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Improving Quality Using Centralised Statistical Monitoring

As the dust begins to settle after the ICH Good Clinical Practice E6 (R2) Addendum, the importance of data oversight and integrity should still not be overlooked. It has become increasingly important to the FDA after the Addendum and likewise for the sponsor’s responsibility to ensure quality management over regulatory submissions.

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Thomas Underwood, Marketing Manager at Quanticate, has over 10 years’ experience within the life sciences industry. Originally working in operations in both clinical data management and programming, he moved into the commercial division and has been in his current role for over eight years. An integral part of Thomas’ role is product development, involving extensive research into industry regulations and the resulting technology and services these influence, such as risk-based monitoring, data quality oversight, and centralised statistical monitoring. He has a postgraduate professional diploma with the Chartered Institute of Marketing and secured Chartered Marketer status in 2014.
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Thomas Underwood
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PredictImmune announce issuance of new patent in the US in support of commercialisation

PredictImmune, developers of pioneering prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated diseases, today confirmed its latest patent grant in the US. The US patent is part of PredictImmune’s third family of intellectual property (IP) relating to methods for predicting autoimmune disease risk. This follows successful grants across the company’s first family of IP in the UK and Europe in October 2018 and Canada in January this year.
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World Pharma Week 2019

17-20 June 2019, Seaport World Trade Center, Boston

World Pharma Week will bring together a unique and international mix of large and medium pharmaceutical and biotech companies, CROs, leading universities and clinical research institutions, emerging companies and tool providers—making it a perfect meeting-place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies.
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