DURHAM, N.C., OCTOBER 27, 2016 — Medical device and diagnostic companies are conducting more clinical trials than ever, a trend that’s giving rise to new procedures and best practices for studies that differ in many ways from pharmaceutical trials. Register for this webinar focused on the evolution of device clinical research on Wednesday, November 2.
Applying Sound Research Practices in Development of Medical Devices will look at how regulators, health care systems, physicians, and even patients are driving demand for expanded research — and how this environment is helping device companies differentiate their products and maximize the likelihood of commercial success. The hour-long session will begin at 11am EDT / 3pm GMT / 4pm CET.
We’ll survey the regulatory landscape in the U.S. and Europe and examine study start-up procedures and the importance of developing investigational plans with clear inclusion and exclusion criteria. Other topics will include:
- Choosing the best sites and investigators and engaging the right subjects.
- The importance of careful vendor selection and staff training.
- Safety reporting and its role in identifying device deficiencies and adverse effects.
- How ISO 14155:2011 is influencing design and conduct of device clinical trials.
Register today for this informative session.
About Premier Research
Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. 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, dermatology, medical device, neuroscience, oncology, pediatric, and rare disease. Premier Research operates in 84 countries and employs 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.