White Papers - Applied Clinical Trials

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White Papers

Clinical Research in Belgium

September 25, 2014

This article examines the landscape for conduct of clinical research in Belgium including regulatory and practical aspects of trial delivery. This white paper also assesses current clinical research activity in Belgium.

EU Recast of Medical Device Directives

September 25, 2014

The regulation of Medical Devices in the EU is changing. This expert white paper introduces in detail the history of the revision of the medical device regulations in the EU. In addition the paper sets out what we can expect from the new Regulation.

Complexity Scoring System in Contract Negotiation

September 25, 2014

This white paper explores the issues surrounding the important site set-up phase of project delivery, and describes the various site contract structures involved. In addition, the white paper introduces a complexity scoring system in contract negotiation to aid project planning and management.

LAMA Therapy: A New Frontier for COPD and Asthma Treatment

September 25, 2014

This article provides expert insights into the development and current status of Long-Acting Muscarinic Agents (LAMAs) and other therapies for the treatment of Asthma and COPD.

Clinical Research in Poland

September 24, 2014

This article examines the landscape for conduct of clinical research in Poland including regulatory and practical aspects of trial delivery. This white paper also assesses current clinical research activity in Poland.

Clinical Research in France

September 24, 2014

This article examines the landscape for conduct of clinical research in France including regulatory and practical aspects of trial delivery. This white paper also assesses current clinical research activity in France.

Electronic Drug Accountability Systems: Ensuring compliance, safety, and data integrity in clinical trials

September 15, 2014

Increases in federal audits and growing federal regulations have made drug accountability management a major challenge. Failed federal audits lead to costly trial delays, and possibly non-approval or criminal liability. Electronic drug accountability managed through an IRT system can ensure compliance, reduce inefficiencies, preserve data integrity and increase patient safety.

Inspection Focus in Clinical Trials Using a Risk-Based Monitoring Approach

September 1, 2014

How will clinical trials that adopt an RBM approach be inspected? Covance shares actionable insights to start answering this vitally important question.

Clinical Trials Tools for All Merge eClinical delivers sophisticated technology that benefits any user

August 28, 2014

Advances in information technology are revolutionizing how CROs, sponsors and academic institutions can design and manage clinical studies. The growth of affordable, secure cloud-based software services, mobile communications and the digitization of clinical data is helping researchers worldwide conduct studies more quickly, efficiently and cost-effectively. In short, the impact of an organization’s size, budget or existing technology infrastructure on its ability to conduct or compete for trials is decreasing. This trend will accelerate in the next few years, offering a range of benefits for sites, sponsors and CROs as well as patients and medical professionals. Using the eClinicalOS platform from Merge eClinical as a case study, this podcast explores the development and application of current and emerging technologies in clinical research.

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