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Aug 04, 2014

Widler & Schiemann Ltd to launch Webinar Service Offering
WSQMS are starting their own webinars to introduce novel concepts in quality management and study management to the clinical community

From October 2014 onwards, Widler & Schiemann Ltd. will start their own webinar series focusing on clinical development with special emphasis on quality and compliance related topics, e.g. risk based monitoring, protocol design, study start-up, risk indicators and other metrics, vendor oversight, and many more.
Watch out for a separate message from us with more details on the webinars!

MHRA on Medical Devices
MHRA response to the Independent Review on access to clinical advice and engagement with the clinical community in relation to medical devices

The Review highlights wider concerns which, according to the MHRA, are not just the responsibility of the latter, but the Agency wants to work in partnership with others to improve patient safety in relation to medical devices and to help drive solutions.
MHRA accepted all of the recommendations. The paper outlines activities already underway and the plans to work better with others to improve patient safety. Widler & Schiemann interpret this as another sign of a tightening of device regulations in Europe becoming a reality. Read the proposal and MHRA’s comments here:

Read the pdf

FDA Revises Policies on Obtaining Informed Consent in Clinical Trials
A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent

"Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation, facilitating the potential subject’s comprehension of the information, providing adequate opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject’s voluntary agreement to participate, and continuing to provide information as the clinical investigation progresses or as the subject or situation requires," FDA explained in its guidance.
FDA’s expectations highlight the pressure for having multiple language, idioms and readability level versions at the fingertip of a clinical trial center team, and this in our opinion calls even more for new effective and efficient technical solutions such as informed consent forms created through Structured Content Management (SCM) solutions.

Details on the FDA website
Details from the RAPS website
Read the pdf

FDA Plans to Get Tough on Poor Data Integrity
The FDA is focusing on the issue because a single data integrity issue calls into question all the data produced by a company, FDA officials said.

The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drug makers backdating manufacturing records and falsifying data.
Investigators are already citing an increasing number of drug makers for data integrity failures, with non-U.S. facilities experiencing most of the problems, agency representatives said at the Food and Drug Law Institute’s current good manufacturing practices conference in Washington, D.C.
What other wake-up call is needed for sponsors and manufacturers to get their records management policy, systems and procedures up to speed?

More details online

Research shows that better use of electronic health records makes clinical trials less expensive
Research using Clinical Practice Research Datalink (CPRD) has shown that using electronic health records is more efficient and less costly

The research has been published by the University of Manchester's (external link) in the National Institute for Research's Health Technology Assessment (HTA)

Full report online
University of Manchester's statement


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Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - -