IDDI Monthly Newsletter - June Edition
IDDI - Regulatory Statistics & Clinical Data Science Experts
Proven scientific and data quality excellence ensuring your clinical trial submissions
🔬📊 Looking for the ultimate news and insights for your clinical trial? Look NO further than IDDI's #CLINICALTRIALSTRIBUNE
Accelerated Approvals (AA) is an IDDI’s Podcast series developed by our leading experts in regulatory statistics and clinical development strategy. This series delves into AA strategy from regulatory and methodological perspectives, with an emphasis on the latest FDA draft guidance on Accelerated Approvals.
The podcast series includes six episodes - Listen now 👇
HAVE A QUESTION ABOUT ACCELERATED APPROVALS? SUBMIT HERE!
Accelerated Approvals: Not So Fast! | Insights for Pharma Executives
The development of drugs and biologics is often a lengthy process that may take many years to complete successfully. Given the resources required during this time, it is no surprise that an accelerated approval (AA) is seen by several companies, particularly small and medium-sized biotechs working in oncology, as an ideal pathway to enter the US market and secure continued funding for their development.
By Everardo D. Saad, MD, Medical Director and Consultant, IDDI and Marc Buyse, ScD, Chief Scientific Officer and Consultant, IDDI
From Design to Submission: IDDI’s Consultancy and Biostatistical Services Have You Covered!
Are you ready to transform your clinical trial from a visionary concept to a successful, data-driven reality with seamless precision? Look no further! IDDI’s consultancy and biostatistical services are designed to propel your research forward, ensuring every phase of the journey is marked by unparalleled excellence and expertise.
Why do so many phase trials fail?
Learn on statistical explanations for a large proportion of Phase III clinical trials failures, and how to address both the overestimation of treatment effects, and the misinterpretation of P-values via Bayesian methods.
We look forward to meeting you at conferences to discuss your needs for your upcoming trials. IDDI combines advanced biostatistics, regulatory and medical expertise, and innovative technology to increase efficiency and mitigate risks throughout the drug development process.
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2wLove your podcasts IDDI - Regulatory Statistics & Clinical Data Science Experts! You offer good information in a very streamlined manner. The podcasts and IDDI are great resources for oncology biopharma sponsors who need information about Accelerated Approvals. #acceleratedapprovals #oncology #IDDI #biostats