TORONTO, ON--(Marketwired - October 20, 2016) - Medical device and diagnostic companies face greater demand to provide clinical evidence of product efficacy than ever before. Scrutiny not only from regulators, but from healthcare systems, physicians, and even patients, has prompted more device companies to perform clinical trials to meet regulatory requirements, differentiate their products, and improve the likelihood of commercial success. While these are similar to well-established pharma clinical studies, there are significant differences.
To understand this trend, it's vital to understand the rationale for development of ISO 14155:2011, which addresses the design and conduct of device clinical trials, in comparison with the ICH good clinical practice standards. Premier Research will survey the regulatory landscape in the U.S. and Europe and examine study start-up procedures and the need to develop a clinical investigational plan with clear inclusion and exclusion criteria. These provide an absolute standard for defining the study population and ensuring subject safety.
Choosing the best sites and investigators and engaging the right subjects -- especially when studying small populations -- is fundamental to successful trials. Vendor selection and staff training are critical as well. Investing time in getting it right from the beginning is foundational to the quality-by-design principles that are increasingly prevalent in the clinical research industry.
Additionally, safety reporting is essential to identifying device deficiencies, adverse effects, and factors that could affect device operators. Good documentation practices, including version control, dating, and signatures, require careful consideration. The speakers will discuss how these practices apply to consent forms, conflict-of-interest documentation, trial master files, monitoring plans, data protection, translations, and risk assessments.
The live session hosted by Xtalks will take place on Wednesday, November 2, 2016 at 11am EDT (3pm GMT) featuring Joanne Emmett, Vice President, Medical Device and Nicky Dodsworth, Vice President, Global Quality Assurance, both from Premier Research, as the presenters.
For more information about this event or to register, visit: http://xtalks.com/Research-Practices-Development-of-Medical-Devices.ashx
About Premier Research
Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, oncology, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.
To learn more about Premier Research visit: premier-research.com
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/sponsorship.ashx
Image Available: http://www.marketwire.com/library/MwGo/2016/10/19/11G118741/Images/Premier_Research_logo-398906951265.jpg