Newsletter | January 20, 2016

01.20.16 -- Mobile Devices In Clinical Trials: Tested, Effective, Proven!

Clinical Leader

inVentiv Health Clinical is a leading provider of global drug development services to the biopharmaceutical industry. We take a patient-centric approach and apply smarter, fresher thinking to go beyond traditional outsourced services, offering therapeutically specialized capabilities for Phase 1 to 4 clinical development, bioanalytical services, and flexible strategic resourcing from a single clinical professional to an entire functional team. As part of inVentiv Health, we can both develop and fully commercialize products for the life sciences industry.
Featured Editorial
Mobile Devices In Clinical Trials: Tested, Effective, Proven!
By Ed Miseta, Chief Editor, Clinical Leader   By Ed Miseta, Chief Editor, Clinical Leader
Patient recruitment and retention remain challenges for most pharma companies. New mobile tools bring the promise of a better patient experience, which would serve to alleviate both problems. And yet the conservative nature of pharma, coupled with regulatory concerns, seem to be keeping these solutions from gaining adoption. It’s no surprise that some technology companies are attempting to prove the effectiveness of these mobile tools themselves.
Managing The Long-Term Medical Expenses Of Adverse Drug Events
By Keith Hoffman, Ph.D., Vice President of Scientific Affairs, Advera Health Analytics
Pharmaceutical developers purposefully enroll subjects who are relatively homogenous in pre-approval clinical trials. They do this to help obtain clear statistical descriptions regarding a compound’s efficacy. Safety profiles, however, can differ greatly between such homogenous pre-approval patients and the heterogeneous population of real-world patients.
Industry Insights
Using Mobile Technology To Support Patients And Complex Protocols In Clinical Studies
Article | By Laurence Burke, VP of Operations, Exco InTouch   Article | By Laurence Burke, VP of Operations, Exco InTouch
For clinical trials to be truly successful, adherence to protocols is essential. However, as trial designs become more complex, sponsors are seeing a worrying fall in compliance levels among both investigators and patients. In this article we discuss the reasons for the drop in compliance and how mobile technology can help reverse this trend.
Development Of Successful Phase 2 Analgesia Protocols
Article | By David Shoemaker, Ph.D., Jack Modell, M.D., Ben Vaughn, and Karl Whitney, Ph.D., Rho
This document emphasizes several key points to consider for Phase 2 analgesia protocol design. The first critical protocol design elements discussed are objectives, clinical endpoints, and proof of concept; these three elements are interrelated, as a successfully met primary objective using established clinical endpoints with regulatory precedent ultimately enables demonstration of proof of concept.
Successfully Ship Temperature-Sensitive Product Halfway Around The World In 48 Hours
Video | World Courier Management
Global logistics are always challenging and, sometimes, even out of this world. World Courier experienced this firsthand when a client asked us to move a temperature-sensitive, high-tech device with an immovable deadline of less than 48 hours.
Taking ePRO To New Places
Video | Medidata Solutions
Chris Tyers of ICON plc shares his views regarding the Patient Cloud, Medidata's solution for patient-reported outcomes that takes ePRO to new places.
Interactive Response Technology (IRT) For R&D Leadership: IXRS3
Almac Clinical Technologies
Active Pharmaceutical Ingredient (API) Development, Characterization, And Supply Services
Publication Services: Disseminate Clinical And Scientific Information
PRA Health Sciences
Late-Stage Clinical Product Development Strategy
Halloran Consulting Group
Upcoming Training

Answering Your Top 5 GCP Questions Of 2015!
Date: Tuesday, January 26, 2016 • Time: 1:00 pm to 2:30 pm EDT

21 CFR Part 11: Understanding The ERES Regulation For Compliance Success
Date: Wednesday, January 27, 2016 • Time: 1:00 pm to 2:30 pm EDT
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