KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Theorem, a leading global contract research organization (CRO) that optimizes trial conduct, will exhibit and present at OCT New England September 16-17. Prithul Bom, MBA, RAC, CSQE, senior director of medical device and diagnostic development, and Brian Bollwage, JD, vice president of global regulatory affairs, will both present.
Bom’s presentation on September 17 at 11:30 a.m. (ET), “Consideration for Adopting an Institution-Wide Regulatory and Clinical Strategy Utilizing a Mobile App as a Research Tool or an Investigational Mobile Medical App (MMA) Device to Improve Clinical Outcomes, Increase ROI, and Lower Costs,” will cover the success factors for effective app development.
“We’re witnessing a significant growth in the number of medical device trials and in the use of apps in clinical research trials,” said Bom. “The direct line to patients that MMAs offer is invaluable for research purposes.”
Bollwage’s presentation, “Investigating IND Success Elements” is September 17 at 9 a.m. (ET). Topics include factors to successful drug development, how to avoid clinical holds when submitting investigational new drugs (INDs) and investigational device exemptions (IDEs) and methods to speed a drug through a successful trial to market.
“A strategic approach to regulatory affairs can reduce development costs and streamline your path to market,” said Bollwage, a regulatory professional with more than 35 years of experience.
“During the presentation, I will share an article that expands on the topics covered in my session.” The article, “Characteristics of the Successful IND or IDE,” addresses common reasons for clinical hold decisions, and the value of pre-submission meetings and transparent communication during development.
Along with the two presentations, attendees can meet the Theorem team at Booth 25 or visit TheoremClinical.com to explore Theorem’s capabilities.
Theorem Clinical Research Inc. is a global provider of comprehensive clinical services with staff throughout the Americas, Europe and Asia-Pacific and a client base comprised of the world’s leading biopharmaceutical and medical device companies. With industry-leading experts, unparalleled therapeutic expertise and innovative, groundbreaking technology, Theorem is focused on analytic-based development, combination trials and personal data applications to simplify complex trials.