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Successfully managing the unique demands of cell therapy supply chains

Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.

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News and Press Releases

Pharma Regulation in a Post-Brexit Landscape

As European pharmaceutical companies invest in new areas of gene and cell therapy, the regulations surrounding these medicinal areas are becoming more and more complex and evolving at a rapid rate. These industry developments add to an ever-changing regulatory landscape, which has led to pharmaceutical regulatory consultancies being increasingly brought in to help these companies navigate the highly technical challenges.
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White Papers

The Role of the CRO in Effective Risk-Based Monitoring


The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.
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Industry Events

12th Annual Paediatric Clinical Trials

19-20 March 2018, Copthorne Tara Hotel, London, UK

SMi is pleased to present the return of their 12th annual Paediatric Clinical Trials Conference taking place on 19th 20th March 2018, London, UK.
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