Pharmaceutical Industry Articles & Reports

Explore AI in regulatory writing: analysis of drafting efficiency, clinical study reports, and key risks like hallucinations and data privacy compliance.

Learn deviation management in Veeva Vault QMS. Compare digital workflows to paper/Excel, covering root cause analysis, CAPA linkage, and 21 CFR 11 compliance.

Compare Veeva Vault, TrackWise, and MasterControl QMS. Analyze features, cloud architecture, and regulatory compliance for pharmaceutical operations.

Analyze the Veeva-Salesforce split impact on pharma CRM. Learn about required changes to integrations, data migration, and customizations by 2030.

Explore AI applications in Veeva Vault RIM for automating submission planning and managing health authority queries. Review industry benchmarks and use cases.

Learn QMS requirements for AI/ML medical devices, including FDA regulations, ISO 13485, data lifecycle management, and model validation strategies.

Explore AI applications in clinical development plans, including protocol optimization, synthetic control arms, and patient recruitment strategies for trials.

A Clinical Development Plan (CDP) outlines the strategy for drug approval. Learn about trial phases, the Target Product Profile, and regulatory requirements.

Learn what PointClickCare EHR is and why it dominates the long-term care (LTPAC) market. This guide covers its core use cases, features, and market share.

Explore the technical and regulatory aspects of Veeva CRM and Epic EHR integration. Covers FHIR standards, HIPAA compliance, and data exchange strategies.

Compare Veeva, Medidata, and Oracle CTMS platforms. Analyze cloud deployment, EDC integration, and reporting capabilities for clinical trial management.

Explore Claude for Healthcare and Life Sciences capabilities. Covers HIPAA-compliant AI, Opus 4.5 integration, CMS data connectors, and drug discovery workflows

An in-depth analysis of the OpenAI Codex app, a command center for AI coding agents. Learn how it enables multi-agent orchestration and parallel workflows.

Analyze 2026 Veeva CRM pricing, per-user license fees, and add-on costs. Review negotiation strategies for Vault CRM enterprise subscriptions and renewals.

Explore Sunshine Act mandates for HCP payment reporting. This guide examines aggregate spend challenges and Veeva solutions for Open Payments compliance.

An in-depth review of inventory software meeting 21 CFR Part 11 FDA rules. Explore key requirements like electronic signatures, audit trails, and ALCOA+ princip

Examine the risks of DIY quality systems in biotech. Learn about FDA Part 11 compliance, data integrity, and when to transition from Excel to eQMS software.

Explore the four layers of a modern biotech software stack—infrastructure, data, apps, and analytics—essential for scaling R&D before Series C funding.

Evaluate TrackWise, MasterControl, Qualio, and QualityOne. Compare biotech eQMS features, FDA compliance, and scalability for startups to enterprises.

Explore the FDA PCCP framework for medical devices. Understand Section 515C requirements for pre-approving AI/ML software changes without new submissions.

Understand FDA SaMD classification for AI/ML devices. Review risk levels (Class I-III), 510(k) pathways, and regulatory guidelines for medical software.

Examine evidence for open-source software in GxP environments. Learn how validation strategies enable compliance while eliminating proprietary vendor lock-in.

Learn 21 CFR Part 11 requirements for electronic records. This guide analyzes cost-effective FDA compliance strategies for small biotechnology startups.

Explore clinical evidence requirements for AI diagnostic tools. Covers FDA/EU regulations, prospective vs. retrospective validation, and performance standards.