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Sponsored Content

5 Guidelines for Writing a Useful Clinical Monitoring Report

January 31, 2019 By Sponsored Content

Taking Your Report from Good to Great By Brandy Chittester, Chief of Clinical Operations A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight […]

Filed Under: Sponsored Content Tagged With: IMARC

Design for Manufacturing Breakthroughs

January 14, 2019 By Sponsored Content

Producing Innovative Micro Medical Devices By Lindsay Mann, Director of Sales & Marketing How to Overcome Roadblocks When Producing a Micro Medical Breakthrough When trying to produce an innovative micro medical design, you may come to a roadblock. What can you do to move forward and get the project back on track? First, determine the […]

Filed Under: Sponsored Content Tagged With: MTD Micro Molding

Global Excellence in Delivery Device Testing

December 31, 2018 By Sponsored Content

Introduction There is a need for a fully-informed laboratory in combination device validation services. The ideal is a laboratory that understands both the pharmaceutical and medical device requirements; from extractables and leachables, through bioavailability, to dose accuracy and ease of use. A good pre-clinical partner/test facility, such as Medical Engineering Technologies Ltd. (MET, www.met.uk.com) can […]

Filed Under: Sponsored Content Tagged With: Medical Engineering Technologies

The Promises (and Problems) of Real World Data

November 26, 2018 By Sponsored Content

By David Kronfeld, Head of Real World Data Innovation, Medidata Solutions Medtech is just starting to access the rich well of real-world data (RWD), which offers some incredible opportunities to build more successful and useful devices. RWD technology can be employed to improve patient recruitment, efficiently deploy a sales team, identify unmet needs in regions, […]

Filed Under: Sponsored Content Tagged With: Medidata Solutions

Putting patients first – e-consent in clinical trials

November 1, 2018 By Sponsored Content

Medical device developers do not always consider the process of informed consent for clinical trials, since it is often handled at the trial site. But the industry is changing, and digitizing processes such as informed consent can streamline studies to rapidly collect quality data, while reducing costs. Patient-centric healthcare means patient-centric clinical trials As the […]

Filed Under: Sponsored Content Tagged With: Medidata Solutions

Preparing for EU MDR Product Submissions: A Sustainable Approach

October 30, 2018 By Sponsored Content

By Michelle Boucher, VP of Research for Tech-Clarity Every medical device company wanting to do business in Europe must comply with the new EU MDR regulation. Yet this is no small feat considering the more stringent requirements. While the new regulation is largely an extension of the existing regulation, it requires far more data. As […]

Filed Under: Sponsored Content Tagged With: PTC

How K2M Tackled UDI and What Comes Next with help from Reed Tech

September 26, 2018 By Sponsored Content

Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people who need it outside K2M. A big challenge facing his team came in 2015, […]

Filed Under: Sponsored Content Tagged With: K2M, reed tech

Efficiency, Transparency and Standardization: The Roadmap for Improved Data Collection in Medical Device Clinical Trials

September 24, 2018 By Sponsored Content

Implementing a unified data platform for medical device trials can yield significant improvements in efficiency, transparency, and standardization, providing resource- and budget-strapped trial teams with accessible, more accurate data for faster, more informed decisions. The era of big data has led to an influx of vast amounts of information coming from disparate sources, causing challenges […]

Filed Under: Sponsored Content Tagged With: Medidata Solutions

Join Cognition Corporation in Boston September 20-21 for NAVIGATE2018

August 15, 2018 By Sponsored Content

By Nick Schofield, Content Creator Interested in networking with and learning from top voices in life science industries about the latest topics and challenges in product development? Are you looking to learn more about how organizations use Cognition’s products and services to help bolster regulatory compliance from premarket to postmarket environments? Then come to NAVIGATE2018, […]

Filed Under: Sponsored Content Tagged With: Cognition Corporation

Bioelectronic Medicine: Targeting Inflammatory Disease with Electricity

April 17, 2018 By Sponsored Content

Clinical Results in RA and Crohn’s, Looking Ahead at MS By Anthony Arnold, CEO of SetPoint Medical Inflammation – it’s a term that conjures up two very different scenarios in the body: one that is vital to healing and another that can lead to chronic inflammatory diseases. Inflammation, at its best, is the part of […]

Filed Under: Bioelectronic Medicine, Clinical Trials, Neuromodulation/Neurostimulation, Sponsored Content Tagged With: SetPoint Medical

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