Newsletter | May 25, 2023

05.25.23 -- Astellas Exec: Responding To A Clinical Hold

Outsourcing Models
India's CROs And CDMOs Come Of Age In The Global Marketplace

Most of the Top 10 pharmaceutical companies and many large biotech companies today get a portion of their preclinical/clinical research, drug development, and/or manufacturing done in India. While a low price is the initial attraction, there are additional factors that can be more meaningful.

How A Flexible FSP Model Fills The Talent Gap

Read about the continuous evaluation and varying opinion regarding the strategic resourcing models employed within the biopharmaceutical sector today.

The Value Of Specialized Expertise For Managing Clinical Supply Budgets

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

Global Sterile Manufacturing And Lyophilization Capabilities Of Biologics

The stability challenges of many biologics require lyophilization to improve product stability, increasing the demand for CDMOs with expertise, scalable development, and manufacturing solutions.

Adding Value With A CRO Partner Program

Learn about a proven, robust technology capable of providing customers with the flexibility to build a range of standardized trials — from simple Phase 1 to complex Phase 3 studies.

Improve eCOA Data Collection And Clinical Trial Efficiency

Improve your eCOA data collection and clinical trial efficiency with Kayentis and ClinOne's combined solution covering eCOA, virtual visits, consent management, patient engagement, and more.


The DIA 2023 Global Annual Meeting invites industry, regulatory government, academics, and patients to network, problem solve, and discuss global and local challenges facing the life sciences community. Hosted in Boston, DIA 2023 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being.

Regulatory & Compliance
Astellas Pharma: Moving On From Clinical Hold

Ha Tran, executive medical director at Astellas Pharma, explains the cause of the clinical hold and the future of the program now that the hold has been lifted.

IVDR Survival Guide: Navigating Product Classification And Compliance

Address common questions concerning the IVDR product classification system and how to comply with the new clinical evidence and performance expectations.

Expert IND Publishing Support For An Understaffed Regulatory Team

See how a clinical-stage biotechnology company was able to successfully file its IND submissions and complete CSR publishing tasks, in addition to creating a synchronized team.

A Toolkit For Sponsors And CROs Shifting Institutional Sites To Central IRB

Discover how having all sites use a central IRB can build efficiencies and results in significant resource savings for everyone involved in the research study and improves human subject protections.

The State Of Global Clinical Trial Disclosure

See what industry organizations are saying about trial transparency, regulations by region, what penalties are on the books, and whether they are enforced.

Gateways To Asia: Market Access In Japan And South Korea

Learn how the recent developments in market access and regulatory rules in Japan and South Korea have paved the way for expansion in Asia.

IQVIA Integrated Global Compliance Solutions

IQVIA offers a complete approach that combines safety, regulatory, quality, and medical information to transform and sustain compliance.

Signal Management In Pharmacovigilance (Virtual: June 12-15, 2023)

DIA Global's upcoming short course offering, Signal Management in Pharmacovigilance, covers essential concepts of signal detection and signal management and provides guidance on how to apply these concepts at participants' functions and their organization, including the data-mining techniques for large volume ADR data analysis. There are only a few seats left, so be sure to register today!

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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)
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