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
The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are critical components of your new drug application (NDA) submission. Presenting the FDA with a coherent and clear integration of the data from your product
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.
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
Pursuing big pharma dreams on a small budget? This webinar will discuss product development strategies for small biotechnology and pharmaceutical companies.
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,
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
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.
This webinar explores both Right-to-Try legislation and existing FDA Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs,
Cannabadiol (CBD) products have been in news a lot recently, but what does it take to bring a CBD product to market for an unmet medical need? This webinar discusses development considerations for CBD and other cannabis-derived products from a clinical, preclinical (pharmacology/toxicology),
