Archive: 2016
Promising Early Results from Apple’s ResearchKit
Nine months after the release of Apple's ResearchKit, we take a look at if it's being used and how well the apps are performing in clinical research. Read More
The Promise Of The Digital Health Revolution For Clinical Trials
The global head of research at Sanofi put a policy in place to attach a digital health strategy concept to each molecule that goes through the pharmaceutical company’s pipeline. Read More
PDUFA and the Patient Voice in Drug Development
With the government’s reauthorization of the Prescription Drug User Fee Act in 2012 (PDUFA V), the FDA is trying an experiment to gather patient input by disease group rather than an individual treatment. Read More
A Path Forward for Novel Clinical Trials in Europe
Pharma companies in the U.S. are working with the FDA to add mobile health tools to clinical trials, but it’s a complex path forward. In Europe, companies have to navigate not one market but several, which means working with several different regulatory bodies and cultures. Read More
How To Drive Value-Based Healthcare for Pharma, Medical and Insurance
How will value-based healthcare be reflected in the pharma, medical and insurance industries? Read More
How to Integrate Two Software Systems?
Many people may believe that if an integration works, it was created the right way. The reality is that an integration working correctly is not necessarily an indication that it was built using the best available methods and, moreover, that it will continue to work correctly five years down the road. Technologies change, products get upgraded, colleagues come and go, data models are modified and of course software has an irritating way of getting "brittle." Read More
From eClinical to Patient-Centered mClinical
What role should patients play in clinical development going forward? Read More
The Journey of a Patient Volunteer as a Hero’s Journey
May 20th is International Clinical Trials Day, a day to recognize the efforts of all those involved in clinical development since James Lind conducted the very first controlled trial, a study of scurvy, in 1747. So on this important date in history, how might these roles map to the roles found in the epic journeys shared throughout human history, from Homer’s Odyssey to the Lord of the Rings? Read More
An Easy Tool to Keep Patients Protocol-Focused
Isn’t it great when you get really good, helpful customer service? Read More
TransCelerate and Medidata Explore SDV Effectiveness in Upcoming Webinar
It’s no secret that clinical trial complexity and drug development costs are at an all-time high. With more than 30 percent of trial budgets allocated to site monitoring costs—and more than half of that being spent on source document verification (SDV) activities¹—the idea of implementing a risk-based monitoring (RBM) program to rid ourselves of the traditional 100-percent-SDV approach has the life sciences industry buzzing. Read More
