Newsletter | November 28, 2023

11.28.23 -- Only Phase-Appropriate GMP Can Meet Clinical Supply Needs

FEATURED EDITORIAL

Adopting A Phase-Appropriate GMP Approach For Clinical Supply

Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

INDUSTRY INSIGHTS

Avoiding The Risk Of A Non-Transparent Clinical Supply Solution

With supply chain and transportation logistics disruptions, full documentation and complete transparency become even more important to avoid delays and assert provenance.

A Novel Approach To Early Phase Studies For Advanced Therapeutics

Clinical research involving rare disease patients raises questions about patient contact, prescreening and screening, management, and logistics. Addressing these challenges can improve outcomes.

Critical Supply Strategies For CROs

Leveraging the expertise of a chosen clinical supply partner can be a valuable resource. Examine key considerations when partnering with a CRO in order to deliver a successful clinical supply strategy.

The Catalyst Of Decentralized Clinical Trials: Combining Clinical And Digital

To build a successful decentralized clinical trial (DCT), you need to consider various factors such as in-home clinical capabilities, logistics, digital platforms, technology, and global reach.

Navigate Complex Ancillary Supply Sourcing Challenges

Explore the evolvement of the clinical trial landscape over recent years, as well as the new challenges that this poses for the clinical supply chain. 

Adapting Drug Supply Strategies To Modern Study Models

Exploring ways to eliminate barriers to enrollment and enable continued participation by bringing trials directly to patients benefits both patients and accelerates drug development.

Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change

A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.

The Ultimate Guide: Scenario Planning Clinical Supply Decisions

Dive into how scenario planning helps you balance risks and costs, choose the best strategy, and provide impact assessment data to stakeholders.

SOLUTIONS

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