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International Clinical Trials
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Clinical trials require the management of more data than ever before, but many of the tools available on the market have prodigious shortcomings in both this and safety. Sponsors and CROs struggle to collect, synthesise and analyse information from myriad siloed sources, which affects their understanding of drug safety and slows data reconciliation for submission. An alternative approach to data integration could power the next generation of clinical innovation by bridging the functional and structural gaps between information management and pharmacovigilance (PV).
Regulatory agencies are concerned about trial data quality and patient safety. The recent emphasis on risk management in the latest ICH E6 (R2) guidelines makes it clear that there is significant work to do in removing the barriers to data review, quality oversight and safety monitoring. Both sponsors and CROs rely on an increasing number of systems and datasets to manage complex and often decentralised clinical studies. Their data are often siloed, which makes obtaining a holistic picture of the trial challenging.
Most data management solutions on the market today are inflexible and fall short in their ability to power the solutions needed to best manage clinical research, particularly as they pertain to timely interfaces with PV. All PV systems will ultimately provide information in the E2B format as required, but data structures from clinical data management systems (CDMS) vary, and conversion to study data tabulation models or other formats can delay key deliverables for holistic study risk and safety management.
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News and Press Releases |
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Nemera organized an expert review on the present and future of inhalation products
“Connectivity in every new inhalation device?” This topic was one of those discussed with different inhalation experts - Manfred Keller, Pascal Cavaillon and Henry Chrystyn – during a round table organized by Nemera in Paris to review the advantages and limitations of inhalation devices.
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White Papers |
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Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control
Berlinger & Co AG
There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
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Industry Events |
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Clinical Trial Supply Europe 2019
13-14 March 2019, Milan, Italy
Following
on from our largest and most engaging meeting to date, Clinical Trial Supply
Europe will be returning to Milan for its 20th year in 2019!
The
19th annual edition welcomed pharmaceutical companies across Europe who got
together to share knowledge and issues regarding clinical trial supplies, both
with regards to operational and technological challenges. Over the two days,
delegates discussed issues which affected their business in our dedicated
operational and technological streams.
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