We find ourselves in the era of modernization following the passage of the 21st Century CURES Act, which ushered in flexible clinical trial methodologies like silico trials, adaptive design, and real-world evidence.
While these progressive approaches can provide many benefits to the companies that use them, they are only as effective as the teams’ understanding and use of them.
Join clinical trial expert Alethea Wieland as she presents her most valuable tips and tricks to help clinical, regulatory, quality, and marketing teams develop a clinical trial program that fulfills global compliance requirements, meets the needs of patients in various regions around the world, and serves as an ongoing compendium of evidence generation.
This free, in-depth webinar will use similar-type case studies that will show you what to expect and do for a successful clinical trials program and market launch for Non-significant Risk (NSR) devices, IVDs, Software as a Medical Device (SaMD), De Novos, traditional Class II and III devices, Digital Therapeutics, and Wellness devices.
Learn about customizable, creative approaches you can use to develop a robust clinical trial program that meets the needs of all relevant stakeholders, taking into account the stringent realities of regulations, like the European Medical Device Regulations (EU MDR), in an attempt to strike the right balance.
Clinical, Regulatory, Quality, and Marketing Working Together From the Start
Establishment of Intended Use and Indications for Use
Early Product Development (e.g., proof-in-concept, early feasibility, or training set trials) That Attracts Early Investors
Pilot-to-Pivotal Clinical Trials and Publications Strategies
Post-Market Clinical Follow-up Studies, Investigator-Initiated Trials (IIT), Post-Approval R&D For New Indications, and Similar Surveillance Programs
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Clinical Research Strategies (“CRS”) is a specialty CRO and executive management consulting firm that fits-for-purpose veteran life sciences executives, attorneys, regulatory scientists and strategists, clinical operations, project management, quality assurance engineers, and sales and marketing teams to take on the biggest challenges for start-up, mid-sized and large life sciences companies. For more information, please visit their website by clicking here.