INSIGHTS ON CLINICAL TRIAL PARTNERING

• Proactive Strategies For Meeting NDA Timelines Despite Last Minute Supplemental Study Requests

  With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug.  Having a CRO that is experienced in the common FDA-required studies for NDA submission can make or break the submission timeline. Nimble responses and expert logistics setups can make all the difference.

• Comparator Sourcing Efficiencies: How To Shorten The Clinical Trial Supply Chain

  At a time of increasing restrictions and pressure on the clinical trial supply chain, it's important for trial sponsors to turn to reliable, timely, and ethical sources for their comparator drug and clinical trial supply needs.

• Transitioning A Phase III Age-Related Macular Degeneration Clinical Trial

  A large pharmaceutical company needed to transition their ongoing study after site selection was complete since the current vendor was not able to offer adequate site support. UBC implemented a transition plan and established strong relationships with the previously selected ophthalmology sites within 6 weeks.

• CROs Are Leading The Charge In New Clinical Trial Technology

  Contract research organizations (CROs) are continuing to lead the industry in improving clinical trial performance. Learn about the role CROs are playing in driving the industry forward in this blog.

• Keep The Best Sites. Protect Patient Safety. Reduce The Safety Reporting Burden

  5/21/2021

  In a highly competitive market, some sponsors are alienating sites and investigators by wasting their time. To reduce the burden on sites, sponsors must rethink how they manage safety reporting. Doing so also improves patient safety and enhances compliance. This blog captures some of the salient points from a recent webinar where Elena Jouravleva, PhD, Director of Regulatory for US Oncology Network, and I discussed the ways safety reporting overburdens sites.

• Veeva Vault Payments Demo: Pay Sites Faster And More Accurately

  1/27/2020

  Watch a 3-minute demo to see how Vault Payments can help you can improve speed, visibility, and accuracy to streamline payments to clinical research sites.

• Mapping The New Landscape Of Orphan Drug Development

  2/4/2020

  The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

• From Psoriasis To Behçet’s: The Evolution Of Biologics In Dermatology

  2/10/2020

  There is a clear shift in dermatology drug development towards biologics, targeted treatments, and rare skin diseases and away from topicals and symptomatic treatments. Learn more about the number of indications that are in development.

• How Will ICH E8 (R1) And E6 (R3) Make Clinical Trials Oversight More Efficient?

  9/1/2021

  Watch this webinar to hear about the forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines, which renew the focus on efficiencies in conducting clinical trials and provide tools to do so – significantly impacting oversight.