Newsletter | February 2, 2023

02.02.23 -- Inside FDA's New Guidance On Early-Phase Cell & Gene Therapy Trials


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
Overcome The Challenge Of CRO Selection

One of the greatest challenges for small pharma and biotech companies always seems to be CRO selection. Aside from the difficult decision of whether to select a large or small CRO, sponsors grapple with CRO location, international presence, and culture. Of course, another primary concern is the quality of the team you will be working with and whether they will provide you with the attention you need.

How CROs Can Simplify Billing

Explore how embracing a robust, modern industry-specific ERP solution can help streamline workflows, reduce errors, improve visibility, and enhance your customer’s billing experience.

Empowering The Clinical Trial Sponsor With Analytics

Industry experts tackle the data quality and oversight challenges they faced with their CROs and discuss how they enabled their clinical teams with self-service analytics.

Outsourcers Are Feeling Uneasy About Continuity Of Supply

Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.

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 complete control of operations is maintained.

Regulatory & Compliance
FDA Releases Final Guidance On Early-Phase Cell And Gene Therapy Trials

The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance.

Rare And Orphan Diseases: Choosing A Path To Regulatory Approval And Market Success

Learn about the challenges of bringing rare disease drugs to market within the U.S. system and some of the guidance for sponsors on meeting them.

Essential Documents vs. Expected Documents vs. Required Documents

What's the difference between essential documents, expected documents, and required documents? Find out more in this blog.

IQVIA Regulatory Affairs And Drug Development Solutions

Discover how offering sponsors end-to-end strategic drug development and technology-enabled regulatory services helps reduce time, cost, and risk, from discovery through post-registration.

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.