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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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FlyPharma Conference Europe 2022 Shares the Latest Supply Chain Challenges and Advice for Better Industry Collaboration
On 20-21 September 2022, the FlyPharma Conference Europe made a
welcome return as a live, in-person event. The conference was warmly
received by its delegates and declared a resounding success, with some
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White Papers |
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Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.
Medpace
Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
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