news roundup
Montrium announced that clinical stage biopharma SignalChem has successfully implemented its eTMF Connect application for their oncology-related programs.
The Veeva 2019 Unified Clinical Operations Survey: Annual CRO Report finds CROs are eliminating manual processes and modernizing key areas of clinical trial execution to enhance partner collaboration and improve study performance, and that information exchange causes major challenges with tracking and reporting (71%), misfiled or missing documents (59%), and a host of other issues that limit collaboration and compliance.
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Anti-Microbial Resistance and the Role of Vaccines
Europe: Thursday, November 14, 2019 at 3pm GMT | 4pm CET
North America: Thursday, November 21, 2019 at 11am EST | 10am CST | 8am PST
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PPD's SiteCoach provides clinical research training, coaching and support to physicians, hospitals and academic institutions that are new to clinical research. Training can be delivered virtually, face-to-face or combined, as needed. Features include a user-friendly online interface, a learner community portal offering resources and tools, a learner forum and mobile gaming designed to increase learner retention.
Applied Clinical Trials and SCORR Marketing will present the findings of our salary and job satisfication survey in the January 2020 issue. Your responses are confidential and information presented in the aggregate.
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Trends and Insights for Your Oncology Trial
Tuesday, November 12, 2019 at 10am EST
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Articles
This article describes that misconceptions around using backup devices for eCOA limits adoption and that with the choice of eCOA back-up solutions now available, implementing an eCOA back-up plan that safeguards, as well as optimizes data collection, has become a streamlined process readily adaptable to the specifics of any project.
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Launching Medical Devices in the Japanese Market
How to navigate regulatory and reimbursement approval
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The Avoca Group's latest survey finds there remains a persistent gap in perceptions of satisfaction between sponsors and providers across several key health indicators for outsourcing, including satisfaction with the relationship, overall work, quality, and value delivered/received.
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Will Decentralized Clinical Trials Compound Patient and Data Quality Risks?
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GrantPlan: Create Grant Budgets with Confidence and Accuracy
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Blog Posts
FDA has established a Rare Disease Cures Accelerator (RDCA) initiative within CDER, with the goal to shift to a more coordinated research approach and methods that can expedite development of drugs to treat some of the 7,000 rare diseases.
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Begin with the End in Mind: The Strategic Benefit of Coordinating Site Budgeting, Contracting, & Payments
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A case that won’t be decided until later this year or next is an appeal by PTC Therapeutics International against EMA's planned release of a clinical study report on its Translarna, an orphan drug to treat Duchenne Muscular Dystrophy. The company maintains that release compromises its commercial interests–particularly since the request for the information came from another pharmaceutical company.
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