Newsletter | September 14, 2023

09.14.23 -- With GCP, Is Being Competent And Qualified The Same?

SPONSOR

Webinar: Practical Approaches To Faster Study Start-Ups — Making Progress In The Face Of Industry Headwinds

Join IQVIA Technologies for an important discussion on the realities of study start-up challenges. You’ll hear use cases from industry leaders that are drilling down into the root cause of delays and using organization, process, and technology levers to claim extra days, weeks, and months in site activation timelines. Click here to learn more.

OUTSOURCING MODELS

Weighing FSP Model Suitability For Clinical Trials

Article | Veristat, Inc.

Consider several key points outlined in this article when deciding if a functional service approach could better serve a clinical team and its drug development study.

Specialized Expertise For Managing Clinical Supply Budgets

Q&A | By Christin Lau, Catalent

A financial project analyst (FPA) plays a critical role in clinical trial supply and budget management. Unearth how sponsors can benefit from having this specialist on their supply partner's team.

Robust Models For Supporting PV And Medical Information Activity

White Paper | By Alisa Hummings and Simon Johns, IQVIA Integrated Global Compliance

Learn how outsourcing local pharmacovigilance and medical information activities to an established safety organization can provide high-quality expertise and technology that meets demand.

Restoring Business Trust And Confidence In Clinical Trials

Brochure | inSeption Group

Inspired by excellence and empowered by people, explore how inSeption Group is able to work as a full-service outsourcing solution to meet and exceed study expectations.

Patient-Focused, Data-Empowered, Delivery-Driven

Brochure | Biorasi

Discover the ways Biorasi is solving the problem of patient access and engagement with data-empowered insights and operational excellence to deliver faster, higher-quality trials.

SPONSOR

Webinar: Slow The Burn — How To Mitigate Financial Risk Before Selecting An Outsourcing Vendor

When you’re in the heart of a clinical trial, facing unexpected budget changes and unplanned change orders can put your entire program at risk. Join this webinar to learn the best practices for safeguarding your trial's budget. Click here to learn more.

REGULATORY & COMPLIANCE

Is Being Competent And Qualified The Same Thing In The GCP World?

Guest Column | By Kamila Novak, KAN Consulting

When it comes to good clinical practice principles, the mention of "competence" is underwhelming. Yet, there is plenty of talk about education, training, and experience. Are "competent" and "qualified" synonymous? Does one imply the other? And why does it matter? Kamila Novak of KAN Consulting explores and explains.

Key Takeaways From The Recent FDA DCT Draft Guidance

Article | By Pamela Tenaerts, Kevin Potgieter, and Mohammed Ali, Medable

Get an overview of draft perspectives and key points to reinforce decentralized clinical trial training, oversight, and risk assessment designed to ensure a study's integrity, patient safety, and success.

Partner Helps Biotech Organization Become Inspection Ready

Case Study | Advarra

Delve into the details of how, after receiving proper consulting, this renowned biotech company was able to conduct thorough site inspection readiness activities and receive an accelerated FDA approval.

The Composition And Value Of A Portfolio Analysis

Brochure | Premier Consulting

Review what makes Premier Consulting’s portfolio analysis so unique, most notably its high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability.

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You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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