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Free On-demand Webinar

Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

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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.

 

Specifically, this webinar will cover:

  • 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

Who should attend?

  • Clinical, Regulatory, Quality, and Marketing Teams who work together in the development and management of a clinical trials program.

Presenter

 Untitled Design (3)

Alethea Wieland
Founder and President
Clinical Research Strategies

Moderator

 Ryan-Behringer

Ryan Behringer
Training and Onboarding Medical Device Guru
Greenlight Guru

 

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About greenlight guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

 

 


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ABOUT Clinical Research Strategies

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.

 

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