Pharmaceutical Industry Articles & Reports - Page 30

Learn the difference between a Company Core Data Sheet (CCDS) and local labels. Explore strategies for managing global labeling deviations, including EMA ePI, IDMP compliance, and AI-powered labeling tools for regulatory compliance

Learn the definitions and key differences between basket, umbrella, and platform trials. This guide explains how master protocols work in precision oncology, including 2025-2026 updates on tissue-agnostic approvals, NCI successor trials (ComboMATCH, MyeloMATCH), and evolving FDA guidance.

Updated for 2026: Compare ISO 14155:2026 for medical device trials vs ICH E6(R3) GCP for pharma. Covers scope, risk management, regulatory compliance, and the l

An in-depth guide to adaptive trial design, updated for 2026. Covers ICH E20 guideline, FDA Bayesian guidance, AI-powered trial optimization, and how prespecified changes based on interim data make clinical trials more efficient and ethical.

Learn what Investigator-Initiated Trials (IITs) are and the regulatory responsibilities clinicians face as a Sponsor-Investigator in academic clinical trials, including ICH E6(R3) GCP updates, EU CTIS requirements, and 2025-2026 regulatory changes.

An educational guide to sample size calculation in clinical trials. Learn the roles of statistical power, effect size, and alpha/beta errors in trial design.

Updated 2026 analysis of cell and gene therapy logistics for clinical trials, covering cryogenic cold chain, chain of identity, decentralized manufacturing, and the latest regulatory developments from FDA, EMA, and ICH

Explore the Bid Defense Meeting (BDM), a critical step for CROs to win clinical trial contracts. Updated for 2026 with ICH E6(R3) guidance, AI-driven bid tools, and current CRO market data. Learn key preparation strategies, sponsor criteria, and best practices.

Explore the rise of CRO consolidation in clinical trials, updated for 2026. Covers major M&A deals (Thermo Fisher/Clario, Fortrea spin-off, Syneos take-private), market trends, AI-driven acquisitions, and the impact on pharma sponsors and trial quality

This guide defines Fair Market Value (FMV) for clinical trial investigator compensation. Learn key regulations like the Anti-Kickback Statute and Stark Law to e

Updated 2026 guide to entry-level clinical trial roles. Covers Clinical Trial Assistant (CTA) and IHCRA positions, responsibilities, salary ranges ($47K-$72K), ICH E6(R3) impact, and career paths.

Learn how MedDRA (v29.0) and WHODrug (688K+ products) standardize coding for adverse events and medications in clinical trials. Covers structure, AI-assisted coding, regulatory requirements, and 2026 updates

Analyze the future of Contract Research Organizations (CROs) to 2030. Learn about market growth forecasts, the impact of AI, and decentralized clinical trial mo

Explore the evolution from paper CRFs to eCRFs for clinical trials. Compare paper vs. electronic data capture (EDC) on data quality, cost, time, and compliance. Updated for 2026 with ICH E6(R3), AI-powered eCRF design, decentralized trials, and the latest EDC market trends.

Learn about the database lock process in clinical trials. Updated for ICH E6(R3) 2025. Covers data integrity, soft vs hard lock, AI-accelerated cleaning, RBQM compliance, and best practices

Learn the key factors CROs use for clinical trial site selection. This guide covers patient recruitment, feasibility assessments, and data-driven methods for su

Learn the complete query management process in clinical trials. This guide covers the workflow, high costs, and impact on data integrity for CROs and sites.

Explore the end-to-end Request for Proposal (RFP) process for clinical trial outsourcing. Learn best practices for sponsors to write and evaluate CRO bids, updated with ICH E6(R3) guidelines and 2025-2026 market data.

A detailed analysis of clinical trial start-up costs, from IRB fees to site activation. Explore 2025-2026 benchmarks, hidden expenses, AI-driven cost reduction, and budgeting strategies for sponsors and CROs

Compare ACRP vs. SOCRA clinical research certifications (updated April 2026). Covers ICH E6(R3) transition, eligibility, exam content, updated fees, and recertification for CCRC, CCRA & CCRP

Learn how to manage protocol deviations in clinical trials. Updated for ICH E6(R3) and FDA 2024 draft guidance, covering classification, reporting, and prevention for data integrity and GCP compliance.

Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. Updated for 2026 with ICH E6(R3), EU CTR 536/2014 CTIS, FDA Dec 2025 guidances, and ICH E2B(R3) mandate. Covers definitions, causality, and expedited reporting timelines.

Learn what an Investigator's Brochure (IB) is, its required content per ICH GCP E6(R3) guidelines (finalized 2025), and its critical role in assessing risk for clinical trials.

Learn the essential CDISC standards for clinical trial data. This guide explains SDTM and ADaM data models, their structure, regulatory requirements, and 2025-2026 updates including SDTM v3.0, Dataset-JSON, and ICH M11.