Newsletter | May 8, 2025

05.08.25 -- The Evolving Landscape Of Data Integrity In Good Clinical Practice

SPONSOR

Don’t miss the next Clinical Leader Solutions Expo—an interactive, multi-day event connecting you with top experts and innovative providers. Services Week, May 6–8, will spotlight patient recruitment and engagement, featuring tools and strategies to reach, retain, and support trial participants. We’ll also showcase CROs with oncology expertise, highlighting how they accelerate and streamline studies. Register only for the session(s) that match your interests.

OUTSOURCING MODELS

With The State Of CRO Monitoring, Industry Must Course Correct

Guest Column | By Penelope Przekop, MSQA, RQAP-GCP

When a sponsor outsources monitoring, it is outsourcing QC. But is that a good thing? PDC Pharma Strategy CEO Penelope Przekop explains why sponsors might want to reconsider its decision to outsource clinical trial monitoring.

Innovative FSP Solutions For Biopharma Growth And Transition

White Paper | TFS HealthScience

To optimize clinical development, the pharmaceutical industry is increasingly adopting innovative outsourcing strategies with CROs.

Five Ways Site-Facing Technology Helps Sponsors And CROs

Article | Florence Healthcare

Site-facing technology is presented as a crucial enabler of efficient trial execution, aligning site operations with sponsor timelines and objectives.

Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs

Article | By Sujata Bhavekar, SGS

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

Advancing Your API To First Human Dose Trials More Efficiently

Application Note | By Ed Groleau, PCI Pharma Services

Learn how end-to-end support for development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging can accelerate drug development and time to market.

Improving Collaboration And Accelerating Clinical Research

e-book | Advarra

This survey explores how the complexity of clinical research has increasingly challenged the dynamics among research sites, sponsors, and contract research organizations (CROs).

Get To Know Biorasi CRO Services

Brochure | Biorasi

This premier CRO exemplifies reliability, flexibility, and accessibility for biotech, providing the skills and expertise needed to meet key goals and critical milestones.

Integrated Programs To Bridge Molecules From Discovery Into Clinical Development

Brochure | Quotient Sciences

A new collaboration helps to remove obstacles from the critical path, reduce development risks, eliminate the white space in pre-clinical drug development, and shorten the path to clinical development.

REGULATORY & COMPLIANCE

The Evolving Landscape Of Data Integrity In Good Clinical Practice

Guest Column | By Andy O’Connor, ERA Sciences

ERA Sciences Andy O'Connor explores the growing focus on data integrity in GCP and how regulatory guidance is evolving to support a risk-based, system-life cycle approach.

How The FDA Is Phasing Out Animal Testing Requirement

Guest Article/Blog | By Mike Fusakio, Ph.D. and Hema Balasubramanian, Halloran Consulting

The FDA is embarking on a transformative initiative to phase out animal testing requirements.

Challenges Associated With Schedule 1 Therapeutic Development

Article | Altasciences

Delve into how recent research on psychedelics and entactogens is beginning to demonstrate potential therapeutic effects of Schedule 1 drugs for various medical indications.

Strategic Regulatory Operations

Brochure | Cencora PharmaLex

Experience seamless regulatory operations with comprehensive submission management from planning to delivery. Ensure compliance and efficiency with expert teams and technology-driven solutions.

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