Newsletter | January 19, 2023

01.19.23 -- How CVS, Walgreens, & Walmart Will Transform Trial Recruitment


Welcome to the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & ComplianceUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
Outsourcing Models
How CVS, Walgreens, And Walmart Will Improve Clinical Trial Recruitment

A new development could potentially change the patient recruitment challenge. In 2022, CVS, Walgreens, and Walmart officially entered the clinical trials space. The patient access capabilities of all three organizations may change the way drug developers access patients while also solving the patient diversity problem.

Are You An Emerging Biotech? Things To Consider When Selecting A CRO

Delve into the understanding of how smaller biotech companies should approach CRO selection and what they should consider before launching their clinical development program.

KPS Life: The Functional Service Provider (FSP) Model, Reimagined

KPS Life brings "A" team resources that are 100% dedicated to sponsors and create a collaborative, supportive process where a complete control of operations is maintained.

Regulatory & Compliance
Avoid Launch Delays By Planning For An FDA-Required REMS

Picture this: The FDA accepts a manufacturer's NDA, and the manufacturer plans for its impending launch. But shortly before the anticipated approval, the FDA notifies the manufacturer that a risk evaluation and mitigation strategy (REMS) program is required to market the product. Now what?

Biotech: Opportunities In China And The Path To USFDA Approval

In this white paper, learn why western biopharma companies should take advantage of China’s revamped regulatory framework.

What The "Current" In Current Good Manufacturing Processes Means

Manufacturers with aging facilities and technologies are certainly in danger of being found by inspectors to not meet the requirement to remain “current” under cGMPs.

Do You Have A Combination Product, And Is It Drug-Led Or Device-Led?

The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”

Navigating New EU Clinical Trials Regulation Requirements For Supplies

Understand Clinical Trials Regulation No. 536/201 (CTR) labeling changes and their potential to disrupt traditional clinical supply strategies should sponsors misunderstand or fail to adhere to the new requirements.

Advarra Regulatory Consulting

Our regulatory consultants take action and move your research forward. If you’re looking for help in the development of innovative life sciences and digital health products, then Advarra is the answer.

Local Affiliate Product Services

Support your local safety needs and drive consistency with global requirements through end-to-end solutions with regulatory-focused medical experts and leading technologies.

Innovation Day At SCOPE With IQVIA Technologies

Monday, February 6, 2023
12:00 p.m. - 5:00 p.m. EST
Rosen Shingle Creek
Orlando, FL

Join IQVIA Technologies’ digital product leaders and customer success experts for an afternoon of discussions and demos. We’ll share our vision to transform clinical operations, the progress we’ve made to date, and our roadmap for 2023 and beyond.