Newsletter | April 4, 2024

04.04.24 -- Why The ‘Illusion' Of Speed Unravels As Contracting Demands Scale

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Webinar: Safety at the Center – The Synergistic Role of Drug Safety in Clinical Trial Operations

In drug safety and pharmacovigilance, collaboration isn’t just a buzzword—it’s an essential component that can impact patient safety and the success of your product. Join us in this webinar as we highlight the importance of effective interpersonal leadership in your drug safety program and reveal the operational and financial efficiencies that can result from a collaborative dynamic. Click here to learn more.

REGULATORY & COMPLIANCE

Informed Consent: Understanding The FDA’s And OHRP’s Joint Draft Guidance

Guest Column | By Liz Oestreich, JD and Thomas R. Berry, PharmD, Eliquent Life Sciences

Explore the details of this jointly issued new draft guidance about how sponsors, investigators, and IRBs should structure and present informed consent documents.

What FDA, EMA Discussion Papers Reveal About AI In Clinical Research

Article | Castor

Learn how having a comprehensive understanding of regulatory perspectives on AI ethics will prove invaluable for researchers evaluating the integration of AI technology into their trials.

Good Manufacturing Practices: When Do They Apply?

Article | By Amanda Bourgeois and Leslie Paul, Advarra

Examine expectations set by the U.S. Food and Drug Administration regarding the implementation of current Good Manufacturing Practices standards for investigational drugs.

Achieving Diversity In Clinical Trials Amidst Regulatory Focus

Article | Medidata AI

Consider several strategies and best practices for how to enhance diversity in clinical trials and how healthcare can be advanced for all ethnic groups.

Local Affiliate Product Services

Datasheet | IQVIA Safety & Regulatory Compliance

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

OUTSOURCING MODELS

Why The ‘Illusion’ Of Speed In Clinical Trials Unravels As Contracting Demands Scale

Guest Column | By Karl Dorwart, Factor

Discover four mistakes biotechs often make in haste (and how to avoid them) as they hurry through clinical trial contracting on the path to commercilization.

A Deeper Dive On Mitigating Financial Risk Before Selecting A Vendor

Webinar | inSeption Group

In part two of this webinar series, presenters focus on avoiding potential risks such as unexpected budget changes and unplanned change orders that could jeopardize the success of a clinical trial.

Keys To Successfully Implementing FSPs

White Paper | PPD FSP Solutions

Delve into the three critical elements for implementing new Functional Service Provider partnerships for streamlining pharmaceutical developments.

APAC Biopharma Companies: Bridge The Gap To The US FDA

Brochure | Biorasi

Uncover how these regulatory and partner/outsource services are invaluable for biopharma innovators in navigating the U.S. FDA regulatory process.

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  • 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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