SOURCE: Medpace

Medpace

March 31, 2015 15:22 ET

Medpace Medical Device to Host Complex Medical Devices Workshops in Boston and San Francisco

Executing Complex Medical Device Trials: Focus on Cardiovascular Device

CINCINNATI, OH--(Marketwired - Mar 31, 2015) - Medpace Medical Device (MMD) announced that it is hosting its second round of complimentary Lunch and Learn workshops in May as part of its series on complex medical devices. "Lessons learned from Executing Complex Medical Device Trials: Special focus on Cardiovascular Device" will be presented by Deborah Schmalz, Senior Director, Regulatory Affairs, and Pirouz Shamszad, MD, FAAP, FACC, Cardiovascular Medical Director at Medpace. These workshops provide a unique opportunity for companies developing medical devices to learn, interact and draw upon the extensive expertise of these industry leaders.

In the workshop, Medpace will share its insights and best practices for bringing a medical device to market as quickly and efficiently as possible. With vast experience in cardiovascular trials, Medpace will use this expertise as a backdrop to discuss the critical factors for designing and executing trials for complex and high-risk medical devices including:

  • Navigating the regulatory pathway in the US and EU

  • Development of objective endpoints and blinding patients

  • Considerations for enrollment and consenting

  • Data considerations

  • Working effectively with core labs

To register:

Boston, May 5
Hyatt Regency Cambridge, 575 Memorial Drive, Cambridge, MA 02139
Register at http://www2.medpace.com/boston-workshop

San Francisco, May 7
The Sheraton Palo Alto & The Westin Palo Alto, 625/675 El Camino Real, Palo Alto, CA 94301
Register at http://www2.medpace.com/workshop-sanfrancisco

Complex Medical Devices -- The Series

Medpace is hosting these workshops as part of its series on Complex Medical Devices -- including webinars, papers and workshops -- which focuses on some of the most challenging issues facing medical device companies. The first workshops held in 2014 highlighted best practices and trends for running European trials and how to harmonize them with a global approval strategy. (Access upcoming events and past resources here: http://www2.medpace.com/complex-medical-device)

Medpace Medical Device, a division of Medpace, is exclusively dedicated to the unique needs of companies developing medical devices and draws upon its extensive experience in designing and managing challenging and complex medical device trials. The company has positioned itself as a strategic partner for delivering end-to-end services starting at early stage through post marketing.

"We have been providing regulatory and scientific consulting, and study management to the medical device industry for nearly 10 years," commented Ryan Wilson, General Manager, Medpace Medical Device. "Companies are looking for a CRO with a deep understanding of the regulatory landscape, a global footprint, and an experienced team of project managers, clinical researchers and regulatory consultants. These workshops, as well as the webinars and whitepapers we are producing as part of the series on complex medical devices, provide a platform to share the lessons we've learned in conducting hundreds of trials in cardiovascular, ophthalmology, orthopedics/musculoskeletal, endocrine/metabolic and urology/urogynecology."

Next up in the Series for those unable to attend the workshops: May 20 webinar -- Lessons learned from Executing Complex Medical Device Trials: Special focus on Cardiovascular Device. Register here: http://www2.medpace.com/Webinar-May20.

Medpace's Full Service Model Becoming Popular in Medical Device Industry

While the medical device industry has lagged behind the pharmaceutical industry in developing an outsourcing model, Medpace is seeing the market respond to the need for executing device studies under a full service model. The ability to fully engage with medical, regulatory and operational teams throughout the study, including project management, data management, and regulatory submissions, Sponsors benefit from a more accountable, seamless, integrated and efficient platform -- increasing quality and speed while significantly reducing a Sponsor's need for duplicate management oversight. With regulatory leadership in the United States and in Europe, Medpace Medical Device can help companies devise a two-continent strategy to accelerate approvals in both regions.

ABOUT MEDPACE MEDICAL DEVICE

Medpace is a global full-service clinical research organization providing core development services for drug, biologic, and medical device programs. Medpace Medical Device (MMD) is a division of Medpace exclusively dedicated to the design and conduct of medical device trials. MMD is headquartered in Minneapolis, Minnesota, and is supported by a European office in Vaals, Netherlands and other locations strategically placed throughout the world. MMD is managed by a team with extensive device industry experience. As a division of Medpace, a global CRO with a 20+-year history, Sponsors gain access to global resources including over 25 medical doctors and over 2000+ employees located in 27 offices and seven labs around the world. Visit Medpace.com/device.