Recently, Apple unveiled ResearchKit. This could dramatically alter the landscape of medical research. ResearchKit is an open-source platform designed to help medical researchers expand their study candidate pools and collect more accurate data. The platform, ResearchKit allows participants to enroll in trials directly from an iPhone and submit data automatically, whether entered by hand or [...]
The 2014 Drug Spending Report issued by The Express Scripts Lab in March of this year indicated a number of industry developments. In the introductory portion of the report, the present shifting of the industry was outlined. The report has been published annually since 1997. The Express Scripts Drug Trend Report provides the healthcare industry’s [...]
Posted on 06. Apr, 2015 by Rob Sims.
Last week I hosted a webinar on Privacy and Data Protection Compliance, and our guest was Mark Lurie of the Lurie Law Firm. You can view a recording of the webinar here. Mark, a former Chief Compliance Officer, shared his insight on best practices for helping employees recognize and safeguard employee and customer data. Mark [...]
Posted on 30. Mar, 2015 by Karl Kapp.
When creating a training program focusing on compliance, sales excellence or understanding of the application of rules and procedures, storytelling can be a powerful method for conveying your message. Research shows that our brains have a natural ability to remember facts told in a story better than facts provided in a list format. So ditch [...]
FDA is requesting a total of $4.9 billion to support various mandates. The budget request is a 9% increase over the FY 2015 budget. The FDA is committed to assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, vaccines and other biological products, and medical devices intended for [...]
Many people reading this blog work in the Life Sciences field which, by definition, includes an understanding of science and the positive aspects that can come from science. This is why the anti-vaccine movement should serve as a warning to those of us who work in this industry. The trend away from proven, safe approaches [...]
Posted on 04. Mar, 2015 by Rob Sims.
Over the past year, the UL EduNeering Advisory Services team helped clients build a measurable and continuous On-the-Job Training and mentoring program that included documented assessments and mentoring programs. In a recent project, we helped a client build an “inventory” of role-based technical skills, focused on topics such as “Good Laboratory Practices” and “Proper Equipment [...]
Here is a small list of recent FDA highlights: On January 1, 2015, the pilot for the Medical Device Single Audit Program (MDSAP) reached a major milestone – manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. were invited to participate in the program. Under this pilot, audits [...]
With the advent of personalized medicine, a key factor in ensuring the right medicine is available for the patient is companion diagnostics. Companion diagnostics are medical devices that help doctors decide which treatments to offer patients and which dosage to give, tailored specifically to the patient. According to the FDA, a companion diagnostic device can [...]