INSIGHTS ON CLINICAL TRIAL PARTNERING

  • 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.

CLINICAL TRIAL PARTNERING SOLUTIONS

  • PCI offers a broad range of services to address the manufacturing needs of our clients at each stage of the product lifecycle. Central to PCI’s international service offering is our capability to manufacture a range of dosage forms in compliance with current GMP standards.

  • In patient support programs, success—and your ROI—rests on making that vital connection between technology and the human touch.

  • PCI provides fully audited, in-house laboratories in both our European and North America locations offering a range of analytical services to support clients in the development and commercialization of new medicines.

  • Greenphire's EnvisiX solution is a budget build and negotiation tool that enables sponsors and CROs to effectively and efficiently build a study budget. The tool provides a streamlined and controlled workflow for budget negotiation for sponsors and CROs with complete transparency and management of rates, adjustments, adjudications, approvals and more.

  • Getting a novel therapy through the clinical development process to approval is complicated, full of challenges, and even more complex in the current COVID-19 world. Learn how to advance your novel  medical therapies from Phase I-III clinical development to market with confidence,