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| home > white papers > Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services - DrugDev |
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 WHITE PAPERS |
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DrugDev
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Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services
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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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News and Press Releases |
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Kieran Coulton named new Chairman at ChargePoint Technology
ChargePoint Technology, specialists in contained and sterile powder
transfer solutions has announced the appointment of Kieran Coulton as
Chairman.
Coulton is an accomplished leader in automation and manufacturing
with a track record of 36 years in the industry. Having previously
served as President Global Industry for GE Power Conversion, Kieran
brings with him a wealth of experience and an ability to achieve
excellent levels of business growth.
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White Papers |
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Future-proofing serialization solutions: the importance of strong level 3 capabilities
Adents
The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
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Industry Events |
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World Vaccine Congress Washington
27-29 September 2020, Walter E Washington Convention Center, Washington, US
The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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