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news roundup
The partnership calls for PRA take on 300 Takeda employees, as well as the management of Takeda's entire pipeline of studies, including Phase I-IV, and provide regulatory, PV and other operational services for both development and marketed product portfolios.
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Partnerships in Clinical Trials USA 2016, celebrating its 25th year. October 5-7 / Boston Convention Center. Push Novel Drugs to Market through Clinical Trials Innovation, Technology and Strategic Relationships. Spotlight session on Zika.  Learn more and register here
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Bracket has randomized its first patient using Precision Block Design (PBD) technology fully integrated into its clinical IRT platform and its mobile application.
Medidata will provide UNCW with access to its Medidata Clinical Cloud® pro bono beginning in the Fall 2016 semester for students enrolled in UNCW's College of Health and Human Services' Clinical Research program.
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 Click here to watch a short video about Covance's Xcellerate Forecasting & Site Selection tool, which helps forecast study timelines and supports selection of optimal investigator sites.
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INC and CISCRP's Inspiring Hope competition finalists will convene in Boston next week to participate in a crowdsolving-type event where they will further develop and present their solutions to the judging panel.
Updated people moves and business recognition for September.
Vote now and at the end of the month, we will provide your answers with expert analysis.
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Regulatory Changes in India and What It Means for Clinical Research in the Country
Live Webinar: Wednesday, October 19 at 11:00am EDT
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New challenges in pharmacovigilance — preparing for ICH E2B (R3) and IDMP implementation
Live Webinar: Wednesday September 21 at 11:00 AM EDT
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Articles
The shift of clinical assessment from the controlled environment of a research site to the uncontrolled environment of a patient's home is a considerable challenge.
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Read this interview with IBM company (eClinical Division), discusses risk-based monitoring (RBM) and how the company is innovating a 25-year-old manual process to enable better monitoring decisions.
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The authors conducted an investigation specifically to identify and describe the basic requirements for technology solutions, as well as the factors considered by successful lean outsourcers in selecting and implementing the right solutions for their companies. |
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Drive better outcomes with improved trial design
Live Webinar: Tuesday, December 6 at 11am EST
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Blog Posts
Despite growing demand for real-world evidence, many studies fail to meet required standards for design, operations and analysis, thus limiting their value to decision-makers.
All data generated by projects funded by Horizon 2020 research projects must be open access, says EU Research Commissioner, who is working to revise EU copyright law, so as to provide a research exception across all member states that will offer a predictable legal framework for text and data mining. |
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Simplifying the complexities of global rare disease drug development
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Risk-Based Monitoring
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Optimizing real-world evidence programs to generate value
Tailored approaches for emerging biopharma
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ERT has updated its Insights Cloud trial oversight solution to enable sponsors and CROs to collaborate by sharing electronic monitoring visit reports and issue management, tracking, and reporting.
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Transforming Patient Recruitment through Patient and Site Engagement
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Sponsors and CROs need to understand how the site role is changing while monitoring, mitigating, controlling risks/issues related to data quality, patient safety, timelines and budget. |
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