Success Story: Support for Vitiligo Pre-IND Submission and FDA Meeting Preparation
Click here for a PDF version of this case study Project Overview The client sought support for their pre-IND (Investigational New Drug) submission and development program. Our goal was to contribute to the clinical section of the pre-IND submission package and prepare clinical questions for their Vitiligo asset. Steps and Actions Taken Step 1: Pre-IND Submission […]
Key Insights from the CDISC TMF US Interchange: What You Need to Know
The CDISC TMF US Interchange conference was a pivotal event for trial master file (TMF) experts from a diverse array of organizations. This annual gathering brought together sponsors, TMF consultants, vendors, and auditors, creating a comprehensive and enriching experience for all attendees. Whether seasoned in the TMF requirements or new to the field, participants found […]
A Phase 1 Study Of The Pharmacokinetics Of Adagrasib In Subjects With Mild, Moderate, Or Severe Renal Impairment Compared To Subjects With Normal Renal Function.
Date:2024-03-28 Authors: C. Cilliers1, P. McCloskey1, J. Morin2, J. Tran1; 1Mirati Therapeutics, 2Innovaderm Research. Category: Other Background:Â This phase I study evaluated the pharmacokinetics of adagrasib in subjects with mild, moderate, or severe renal impairment compared to subjects with normal renal function. Read more on pubmed
In-Person Breakfast Event at the AAD â Exploring the Innovation and Research on Alopecia Areata
Innovaderm was in San Diego for the 2024 edition of the AAD annual meeting and hosted its 5th Breakfast Event:Â Exploring the Innovation and Research on Alopecia Areata (AA).
“Clinical Development Strategy that Patients Need and Investors Want” by Dr. Jasmina Jankicevic
Innovaderm is thrilled to announce that our team was present at the AID Dermatology Summit in San Francisco on January 7th! Our very own Chief Medical Officer, Dr. Jasmina Jankicevic, delivered an insightful presentation titled âClinical Development Strategy that Patients Need and Investors Wantâ. Dr. Jankicevic’s talk was nothing short of incredible, shedding light on […]
Clinical Trials Information System (CTIS)
Attention all clinical trial sponsors who are planning to conduct a study in the EU or EEA! The Clinical Trials Information System (CTIS) must be used to submit any new clinical trial application in these regions. This process permits a single application to secure authorizations in up to 30 countries! Watch the following webinar part […]
