May 24, 2016
Identity trust platforms assure clinical investigators that their credentials are legitimate by allowing use of a single identity that can be recognized across multiple entities. These platforms support collaboration by allowing drug development participants to access data, sign and exchange documents.
May 23, 2016
Autism Spectrum Disorder (ASD) is a common neurodevelopmental disorder which does not have an approved medication to address its core symptoms. The Janssen Autism Knowledge Engine (JAKE) was designed to advance the clinical research process for autism by integrating emerging technologies into traditional clinical trial processes.
May 23, 2016
Regardless of whether the UK does decide to leave the EU or not, the concern over medication will remain for the rest of Europe. The needs of these countries will persist at a human and public health level for more effective medicines and more effective ways of paying for them.
May 20, 2016
Clinical trials of the future may be closer than we think as we strive to deliver smarter, faster and more cost effective treatment to patients. The data exists to make this possible, now we must change our thought process to meet the needs of patients and sponsors.
May 18, 2016
Pfizer has created a clinical trial modeling tool for mitigating study risk during the protocol design and study execution phases. Jonathan Rowe speaks with Moe Alsumidaie on the purpose behind these predictive models.
May 18, 2016
Peter O'Donnell writes that the EMA surprisingly diverted from it's usually strict boundaries on it's annual report published in May.
May 17, 2016
A risk-based approach to quality trial oversight, adopted by the FDA and EMA, has resulted in an array of new technology solutions being released.
May 09, 2016
The early implementation of post authorization safety studies (PASS) will translate to efficiencies in pre-appoval research. These benefits allow for faster approval and wider patient access to potentially life saving therapies.
May 05, 2016
FHIR (pronounced "fire") is a new, free of cost, platform that has the ability to access and create data though EHR systems. Wayne Kubick writes that using such a platform could truly re-engineer how pharma collects data during clinical trials.
Apr 29, 2016
Sponsors and their contractors have faced challenges when ensuring that parties involved in global clinical trials adhere to rules and regulations regarding biomedical research. For an effective collaboration to take place, all parties must meet the expectations and accountabilities detailed in the trial contract.
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