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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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Merck Expands Excipients Portfolio, Adding Polymers for Sustained Release Injectables
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White Papers |
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Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services
DrugDev
With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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Industry Events |
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Pharmaceutical Microbiology East Coast
13-14 November 2017, Renaissance Woodbridge Hotel, New Jersey
Drawing on from the huge success of SMi’s Pharmaceutical Microbiology event series, SMi is delighted to announce the launch of Pharmaceutical Microbiology East Coast. Being the eighth in its series, this event will take place in New Jersey, USA, on November 13th and 14th 2017. Aimed at Microbiologists, Quality Control and Quality Assurance Managers, Pharmaceutical Microbiology East Coast 2017 will address the best practices for rapid microbial and sterility testing and tackle the challenges of contamination control.
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