Good to “See” You Here!

I’m Jesse Meaux, Associate Director of Business Development for WCG’s Scientific and Regulatory Review Group. Please consider me your go-to-contact for Moderna.

In advance of our introductory meeting, please review the material below to learn more about WCG’s Scientific and Regulatory Review services. If you have any questions or would like to use our services on an upcoming program, please click the EMAIL JESSE button! In the meantime, please enjoy these resources, and I look forward to Moderna and WCG’s growing partnership!

Jesse Meaux
Associate Director of Business Development, WCG

Phone: 818.438.1212

Explore our Scientific & Regulatory Services

Endpoint Adjudication Committees

WCG’s Endpoint Adjudication Committees (EACs) help the biopharmaceutical and device industry to lower the risk of variation in important clinical trial outcome events for submission to regulatory agencies.

Data Monitoring Committees

As an industry leader in Data Monitoring Committee (DMC) management, our managed DMC solutions deliberate over un-blinded data to provide recommendations to the sponsor as to whether a trial is continued, modified, or stopped because of safety concerns, overwhelming benefit, or treatment futility.

Statistical Consulting

In addition to the common consulting arenas of trial design and regulatory strategy, we assist our clients with complex situations, including sensitivity analyses, simulation studies, evaluation and verification of statistical analyses performed by others, post-hoc assessment, due diligence review, and expert witness testimony.

Drug Safety

WCG’s seasoned healthcare professionals deliver unmatched expertise in tracking and investigating serious safety reports. We work with your team to design the systems and processes needed to achieve extraordinary levels of vigilance, as well as documentation you—as well as regulators—can trust.

Pharmacovigilance

The key to successful pharmacovigilance programs is treating product inquiries and complaints as early-warning safety intelligence. By understanding the sometimes-obscure nature and pattern of these inquiries, WCG helps pharmaceutical companies not only to respond promptly and appropriately to individual queries, but also to prepare for and manage deviations of greater scope. It is through this expertise that we help clients recognize inquiry trends early, so they’re able to respond definitively and with discernment—before issues expand into broader safety concerns.

Imaging Core Lab Services

Full-service medical imaging core lab supporting Phase I-IV Clinical Trials and Class I, II, III Medical Device Trials with comprehensive medical imaging core lab services including overall leadership, project management, imaging charter development, image acquisition protocols, imaging site qualification training and management, patient scan transfer and quality control and radiology review.

WCG Services: Aligned to Your Needs Throughout the Study Continuum

WCG comprises a suite of clinical research services, divided into two operating organizations: WCG Ethical Review and WCG Clinical Trial Solutions.

Within our WCG Clinical Trial Solutions Services segment, we support Study Planning & Site OptimizationPatient Engagement, and Scientific Review.