This article is written by our guest, Sibu Mdlalose, Director: Business Development & Client Relations, LogicTrials South Africa. Logic Trials is a strategic operations partner of DZS Clinical Services. South Africa changes rules for complementary medicines On Monday, 22 September 2014, the Department of Health in South Africa published draft regulations to amend the general regulations […]
Functional Outsourcing, Gender Bias, and Heart Monitors: What We’re Talking About This Week
Looking back on the week that was, here are some of the headlines we were talking about: A PM’s perspective on functional outsourcing, gender bias in clinical trials, and a new heart monitor. 1. Functional Outsourcing in the Pharmaceutical Industry – a Project Management Perspective A great article about functional outsourcing from a project manager’s […]
This Week We’re Talking About: Big Data, Diversity, and WAK
A busy week in clinical research but we think you’ll enjoy these 3 intriguing articles! 1. FDA Greenlights First Human Study of Wearable Artificial Kidney The FDA recently gave the green light to medical researchers to begin the first human study of the device in the United States. WAK, a small dialysis machine that is worn like a belt and […]
Using Diversity as a Study Metric in CTMS
Clinical Trial Participation Part 3: The third of an ongoing series of articles examining critical issues concerning clinical trial participation Using Diversity as a Study Metric in CTMS In part three (click here for Part 1 and Part 2) of this ongoing series, we examine how Clinical Trial Management Systems (CTMS) can assist in helping to monitor diversity […]
This Week We’re Talking About: Data, Contrave, and Arthritis
Hot topics this week include clinical trial data, the new weight management drug Contrave, and good news for those suffering with rheumatoid arthritis! 1. NICE to Seek Greater Access to Clinical Trial Data NICE (National Institute for Health and Care Excellence) will ask the European regulatory authorities for access to clinical trial data if relevant […]
This Week We’re Talking About: Amino Acid, FDA, and EU Clinical Trials
A new Amino Acid, the FDA and New Regulations in Europe are our main topics of discussion this week! 1. A New Synthetic Amino Acid for an Emerging Class of Drugs A synthetic amino acid has been developed that can impact the 3D structure of bioactive peptides and enhance their potency. 2. FDA Fast-Tracks Merck & Co Antibiotic Relebactam, […]