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LIVE WEBCAST: Wednesday, October 27, 2010 at 2:00 pm ET
Enhancing Clinical Operations with Digital Signatures
Learn how digital signatures enhance clinical operations – from expediting site initiation to completing site monitoring and streamlining quality, audit and compliance. Save time and money by replacing paper and routing with compliant digital signatures.
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ON DEMAND WEBCAST
Harnessing the Power of CTMS for Small and Mid-Size Biopharmaceutical Companies
Clinical trials are continuing to become more complex, yet many companies are forced to manage their trials with inadequate systems relying solely on individually maintained documents, spreadsheets and emails. The use of a professional, company-wide CTMS has historically been the domain of larger Pharma and CRO businesses. Today, with CTMS accelerators ensuring rapid and cost effective implementation, as well as enhanced support of the end-to-end business processes necessary for conducting a clinical trial out of the box, CTMS is now a very viable option for small and mid-sized businesses.
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Protecting Subjects: The IRBs Next Steps
The vital role of the Institutional Review Boards (IRBs) to the welfare of subjects remains central to their mission. Last year, IRBs had to weather difficult scrutiny and challenges, from which they have emerged stronger. “Protecting Subjects: The IRBs Next Steps” offers insight into the IRB’s mission, its challenges and how they prepare sponsors, CROs, sites and others to handle safety and compliance in a complex clinical trial environment.
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Trends in Subject Recruitment 2010
Subject recruitment remains one of the pivotal challenges—and high cost items in regard to trial delay—in the clinical trials process. Industry analysts’ Frost & Sullivan say subject recruitment problems will continue to dominate the industry for the next five years. Inside, MMG, Praxis, Industry Standard Reports and Medici offer their expertise on how sponsors can improve patient access and retention.
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Retrospective Look at the Clinical Trials Market
A look back and a look forward to the most important topics in the clinical trials industry. This supplement includes the Top 5 most-searched articles from the Applied Clinical Trials Website; an executive summary of those articles and insight from top experts on what to expect on the topic in the coming years; as well as an Industry Timeline, which pinpoints the most important developments of the clinical trials industry over the past 20 years.
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Patient Reported Outcomes 2010
With final guidance from FDA on Patient-Reported Outcome (PRO) measures in medical product development released in December 2009, industry response was quick and positive. In addition to PRO needs in clinical trials, the patient reported outcome is an integral part of outcomes studies, registries and drug safety initiatives. This insert offers targeted information from the organizations that support sponsors in their myriad of PRO challenges to help them navigate the new PRO field from practical tips to suggestions on the best ways to collect data via ePRO.
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The Value of Modeling and Simulation to Support End of Phase II Meetings and Pivotal Trial Strategy
The following short case study from Pharsight’s consulting practice offers further evidence of the impact and value of pharmacometric analysis. Integrated modeling of Phase II and literature data for a sponsor’s CNS compound, combined with simulation of Phase III trial designs, provided a compelling case to FDA to support registration without running an additional pivotal Phase III trial - saving months of development effort, millions of dollars and offering the promise of making a beneficial treatment available to patients much sooner. FDA recently approved the drug candidate in the target indication.
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Clinical Trial Management: Enabling Operational Efficiency
Click here read to read about some of the most pertinent challenges facing the biopharmaceutical industry and how organizations are increasingly turning to clinical trial management systems (CTMS) to improve trial efficiencies, cut trial costs, and enhance the productivity of trial participants. Brought to you by Oracle and Touch Briefings.
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