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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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A new market reference added to Safe’n’Sound®, our passive safety device platform
Safe’n’Sound® is on the market in Europe with a newly registered injectable medication.
The commercial launch of HULIO™ (Adalimumab Biosimilar) was initiated in selected European markets on October 19,2018.
Hulio™, developed by Fujifilm Kyowa Kirin Biologics Co., Ltd. and marketed in the European Union by Mylan N.V. is approved as a biosimilar for the same indications as the reference product, Humira®.
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Industry Events |
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SCOPE Summit for Clinical Ops Executives
18-21 February 2020, Hyatt Regency, Orlando, Florida, US
Celebrating its 11th successful year,
SCOPE Summit 2020 takes place February 18-21 in Orlando, FL. Over the course of
four stimulating days of in-depth discussions in 20 different conferences, 3
plenary keynote sessions, the annual Participant Engagement Awards, and the
ever-popular interactive breakout discussions, the programming focuses on advances
and innovative solutions in all aspects of clinical trial planning, management
and operations
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