Webinars

Webinar

Tips for a Successful NDA Submission

Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market.  This webinar will share tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.

Webinar

Improve the Inclusion & Exclusion Criteria for Your Next Clinical Trial

Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study. In this webinar, Dr. Modell will provide suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments.

Webinar

Protocol Design: What You Need to Know to Ensure a Successful Study

Solid protocol design is critical to clinical development.  No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing.  In this webinar, Dr. Shoemaker and Dr. Kesler will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.

Webinar

Get Your Development Program Started on the Right Foot

This webinar will review the content of both the Target Product Profile (TPP) and the Integrated Product Development Plan (IPDP), demonstrate how they are written, and provide specific examples of decisions that are made as a result of the use of these documents.

Webinar

Putting Patient-Centric Principles into Practice

This webinar will explore the rationale for implementing patient-centered practices and offer guidance for initiating patient-centered approaches to research.  Presenters will review practical strategies for engaging patients in the clinical trial process without sacrificing research quality or adding untenable costs to your trials. With more than 20 years of experience successfully implementing patient-centered strategies, our experts share which factors matter to patients and how to design trials that honor their needs and desires.

Webinar

Understanding Common Causes of Failure in Depression Studies

The failure rate of clinical studies in depression is high, and placebo response is often blamed.  In this webinar, Dr. Jack Modell, a board certified psychiatrist with more than 35 years of experience in clinical research and patient care, discusses why there is more to the story than placebo response.  Additionally, Dr. Modell addresses steps that can be taken to avoid these pitfalls.

Webinar

Not Just Tiny Humans: Conducting Pediatric Clinical Trials

From study design to logistics to recruitment, there are key differences between studies in pediatric populations and studies in adult populations. This webinar examines what it takes to successfully conduct a pediatric clinical trial.