Pharmacovigilance & Safety

Nicole Dale

The Latest Evidence on Informed Consent in Clinical Trials

Pharmatica image representing informed consent in clinical trials with digital eConsent technology, participant engagement, clinical research ethics, transparent communication, and modern clinical trial management.

A recent systematic review reveals incredible detail about informed consent in clinical trials, participant understanding, and trial quality. Find out now.

Nicole Dale

Claude Science: An Operating System for AI-Driven Pharma R&D

Pharmatica photo‑realistic representation of scientists collaborating in a unified AI‑driven pharmaceutical research environment using Claude Science, integrating genomics, structural biology, cheminformatics, and AI-assisted pharmaceutical research

Claude Science is a new AI R&D tool for drug discovery, integrating 60-plus scientific databases into one place. Here is what pharma R&D teams need to know.

Nicole Dale

FDA Master Protocol Guidance for Smarter Clinical Trials

Clinical research laboratory featuring a Master Protocol document, laboratory samples, and digital analytics, representing clinical trial efficiency for precision medicine research under the FDA Master Protocol guidance.

Explore the FDA's Master Protocol guidance and how basket, umbrella, and platform trials can improve clinical trial efficiency, especially in oncology and biologics.

Nicole Dale

One Pivotal Trial for FDA Approval? Success Depends on Trial Design

Pharmatica image of a modern pharmaceutical regulatory affairs workspace representing documentation, compliance, and submission processes essential for FDA drug approval. The scene shows three binders labeled “Regulatory Affairs,” “Submissions,” and “Compliance” on a clean office desk with documents and a pen in the foreground, while a blurred meeting of professionals is visible through a glass wall in the background. The composition conveys administrative precision and regulatory science underpinning.

One pivotal trial for FDA approval could accelerate drug development, reshape clinical trial strategy, and change the pharmaceutical regulatory landscape.

Nicole Dale

FAST-EU Pilot: Can Europe Finally Accelerate Multinational Clinical Trials?

Pharmatica image representing the FAST-EU Pilot supporting multinational clinical trials through coordinated European regulatory collaboration, accelerating clinical trial approvals under the EU Clinical Trials Regulation (CTR).

The FAST-EU Pilot aims to accelerate multinational clinical trials through faster coordinated assessments, supporting Europe’s 2030 clinical research ambitions.

Nicole Dale

FDA Oncology Trial Guidance Targets Eligibility Barriers

Pharmatica image showing new FDA oncology clinical trial guidance for clinical trial eligibility represented through connected patient assessment, clinical research data, and trial pathways.

FDA oncology clinical trial guidance targets restrictive eligibility criteria, covering performance status, washout periods, medications, and laboratory values.