NIH, FDA Seek Broader Disclosure of Clinical Trial Results
September 19th 2016After months of debate, clinical research activity regulated or funded by the government must adhere to revised guidelines regarding transparency. A final rule published by the Department of Health and Human Services states that all beyond Phase I FDA regulated and NIH funded clinical trials must comply with the new requirements.
Specialized Travel Services Can Help with Patient Retention
September 19th 2016Clinical trials endure high drop out rates due in part to long schedules, high travel costs and long reimbursement times. Outsourcing specialized clinical trial traveling services can help alleviate this concern by allowing sponsors to efficiently manage travel and other expenses.
Eliminating the Three Evil "E's" in Starting Clinical Trials
September 16th 2016Pharma has been transitioning from its paper based methods of the past toward automated cloud based systems in order to offset the cost of drug development. The emphasis is now shifting toward improved study startup processes for shorter clinical trial timelines.
Creating a Self-Sustaining Clinical Trial Quality Management System
September 16th 2016Large clinical research enterprises have the resources to establish high standard clinical trial Quality Management Systems, while smaller enterprises may not have the means to do so. This article covers how clinical research enterprises can leverage technologies to develop an efficient clinical trial QMS.
Lean Outsourcing Models for Clinical Trials, Part 2: Optimizing Technology
September 15th 2016A key success factor for lean models is the possession of technology that can measure performance and manage risk in a well-organized and user-friendly manner. This article describes the results of an investigation to identify and describe the basic requirements for such technology solutions.
Technology That Touches the Patient
September 14th 2016What used to be segregated approaches in clinical trials-ePRO, telemedicine, mobile health, devices and wearables-now gather under the umbrella of technologies that touch the patient. And those technologies can have positive implications for costs efficiencies in clinical trials, streamlined data collection, as well as on patient compliance and retention.