|Study Sites: Show 'Em Your QC
Polaris Compliance Consultants
How can you make your research site stand out so you win more studies? Show ‘em your QC! A reasonable set of Quality Control procedures will convince Sponsors/CROs your site can be counted on to produce reliable data. It shows that managing quality at your site is a continual process, and doesn’t wait for their monitors to arrive. Here's some advice to get started.
E-Labeling... And Then Some
Janssen Research and Development has developed iSTEP, an intelligent packaging system for Investigational Product. The package is scanned when it leaves the company and scanned when it’s dispensed to the participant. Once the IP reaches the research participant, a smartphone app determines when the blister pack is opened so site staff can monitor drug compliance. The app provides the participant with informational videos and reminders, messages of encouragement, and important notifications from site staff.
RBM on Trial
Four years ago we published an article describing ADAMON, a rigorous, multi-year study to compare the effectiveness of RBM to that of traditional monitoring. The study is now complete, and the results are in. After 156 GCP site audits -- 1/2 of the sites having received RBM, 1/2 having received traditional monitoring – ADAMON concluded that "the potential benefit of extensive on-site monitoring is small relative to overall finding rates." Lotsa stats available in the study report for you data hounds.
Gene Therapy Has a GMP Problem
FDA and 3-D Drug Manufacturing
3D printing offers a number of advantages over traditional batch methods of drug manufacturing. Spritam, the first 3D-printed drug, has already been approved. Here’s what FDA is considering and doing to prepare for this new manufacturing method.
EKG: Easy as ABC
Kardiaband, a new accessory for Apple Watch has been cleared by the FDA as a medical device. Pair it with an app on your smartphone and voila -- an EKG reading.
Polaris Compliance Consultants News
Polaris is pleased and proud to welcome Diane Tilley as our new Director of GCP. Diane has had a broad career working as a clinical research professional, a licensed attorney, and a certified Family Nurse Practitioner. She’s served as Director of QA for both large and small CROs, and also has experience working in the university and private practice settings. With that resume, Diane had her choice of companies, so we’re really glad that she chose to come to Polaris and work with us and our clients.
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