Pharmaceutical Industry Articles & Reports - Page 34

An in-depth 2025 analysis of the leading medical imaging and digital pathology AI vendors. Covers market size, deep learning trends, and top company profiles.

Our 2025 report analyzes the critical AI skills gap in the pharmaceutical industry, detailing the talent shortage with data and exploring key solutions.

An in-depth guide to IT system assessment in pharma M&A due diligence. Covers infrastructure, data, cybersecurity, AI governance, NIS2/CRA compliance, and FDA cybersecurity guidance for 2025-2026 deals.

Explore a detailed cost-benefit analysis of RTSM implementation in clinical trials. Learn how RTSM systems reduce drug waste by 15-30%, save millions, and align with ICH E6(R3) and AI-driven forecasting trends in 2025-2026.

Learn how target trial emulation provides a structured framework for drawing causal inference from real-world evidence (RWE), with 2025 updates on the TARGET reporting guideline, ICH M14, and FDA guidance.

Explore biotech salary trends across global regions, updated with 2024-2025 data. Compares pay in top hubs like the US, Switzerland, and Asia-Pacific with cost-of-living analysis and funding recovery trends.

Updated 2026 Epic vs Cerner AI comparison. Native AI Charting, CoMET foundation models, Oracle's next-gen EHR, Clinical AI Agent results, and the reshaping ambient scribe market.

Learn the GAMP 5 software categories for computerized system validation. This guide explains each category with examples, risk levels, and how they align with the 2025 ISPE GAMP AI Guide and FDA CSA framework.

A comprehensive guide to lab equipment qualification (IQ/OQ/PQ). Learn the process, regulatory standards including FDA's finalized CSA guidance, and how AI-powered automation streamlines validation and compliance.

An in-depth review of Certara's drug development software suite for MIDD, updated for 2026. Covers Phoenix WinNonlin, Phoenix Cloud, the Simcyp PBPK Simulator, Certara IQ AI-powered QSP platform, and ICH M15 adoption.

Learn the key differences between GAMP 4 and GAMP 5. Updated for 2026 with FDA's finalized CSA guidance, ISPE GAMP AI Guide, and EU GMP Annex 11/22 drafts. Clear migration path for pharma IT.

Learn about Japan's PMDA regulatory pathways for drug approval under the PMD Act, including 2025 amendments. Covers standard and expedited options like Sakigake, Orphan Drug, and Conditional Approval

Updated 2026 guide to ICH M7 mutagenic impurity assessment software including Derek Nexus 6.5, Sarah Nexus 5.1, Leadscope 2025.0, OECD QSAR Toolbox 4.8, AmesNet deep learning, and nitrosamine regulatory developments.

A detailed analysis of the global pharmaceutical market, forecast to reach $1.6T by 2025. Explore key growth drivers, therapy areas, and industry challenges.

An in-depth study of pharmacy management systems updated for 2026. Explore key software features, compare top vendors (RedSail, Outcomes/TDS, Epic, Oracle Health), and learn about AI, DSCSA compliance, and market consolidation trends.

Learn about Patient-Reported Outcomes (PRO) systems in clinical trials. This guide covers ePRO data collection, PROMs, FDA PFDD guidelines, CONSORT 2025 updates, AI-driven ePRO platforms, and challenges

Updated 2026 guide to AI-assisted surgery companies including Intuitive Surgical's da Vinci 5, Medtronic Hugo (FDA-cleared Dec 2025), CMR Versius Plus, Stryker Mako 4, and more. Market data, clinical outcomes, and regulatory trends.

An in-depth analysis of the ICH E6(R3) Good Clinical Practice guidelines for 2025. Explore key changes in Quality by Design, data governance, and decentralized

An in-depth guide to ICH Q10 Pharmaceutical Quality Systems (PQS), updated for 2026 with ICH Q9(R1), Q12-Q14 developments, FDA QMM program updates, and AI-driven quality management trends.

Updated 2026 guide to synthetic data in pharmaceutical research. Covers acceptance criteria for fidelity, utility, and privacy, plus latest FDA/EMA AI guidance, EHDS, and diffusion model advances.

An overview of value-based contracting (VBC) in pharmaceuticals, where drug prices are tied to patient outcomes. Covers models, challenges, case studies, CMS CGT Access Model (2025), finalized VBP rule (2026), and IRA drug price negotiations.

Updated 2026 guide for IT on 21 CFR Part 11. Covers FDA CSA guidance, AI compliance, electronic records & signatures, system validation, audit trails & data integrity

Learn best practices for writing an effective FDA 483 response. Updated with FY2024-2025 enforcement data and FDA's AI-driven inspection targeting. Covers CAPAs, timelines, and strategies to avoid Warning Letters.

An analysis of the 2025 surge in new drug manufacturing plants from Eli Lilly, AstraZeneca & more. Learn about the key drivers: supply chain & geopolitics.