
Learn the key differences between GAMP 4 and GAMP 5. This guide for pharma IT covers the shift to risk-based validation and provides a clear migration path.

Learn the key differences between GAMP 4 and GAMP 5. This guide for pharma IT covers the shift to risk-based validation and provides a clear migration path.

Explore a data-driven profile of Peter Gassner, the founder of Veeva Systems. Learn about his career, Veeva's vertical SaaS strategy, and its growth.

Learn about Japan's PMDA regulatory pathways for drug approval under the PMD Act. This guide covers standard and expedited options like Sakigake and Orphan Drug

Understand the ICH M7 guideline for assessing and controlling mutagenic impurities in pharmaceuticals using in silico (Q)SAR software, TTC, and risk-based metho

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. Explore key software features for dispensing, inventory, and billing, and compare top vendors in the market.

Learn about Patient-Reported Outcomes (PRO) systems in clinical trials. This guide covers ePRO data collection, PROMs, FDA regulatory guidelines, and challenges

An educational overview of AI-assisted surgery, profiling top companies like Intuitive Surgical, Medtronic, and J&J. Learn about robotic platforms and market da

This analysis examines the 2019 Veeva Crossix acquisition, detailing the integration of patient data with Veeva CRM and its impact on pharma marketing analytics

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 the ICH Q10 model for Pharmaceutical Quality Systems (PQS). Explore its core elements, lifecycle approach, and integration with GMP regulat

Learn about synthetic data in pharmaceutical research. This guide covers acceptance criteria like fidelity, utility, and privacy for clinical and pharmacovigila

An overview of value-based contracting (VBC) in pharmaceuticals, where drug prices are tied to patient outcomes. Learn about models, challenges, and examples.

Compare Veeva vs Salesforce for life sciences CRM. This analysis covers features, GxP compliance, and the strategic shift to Veeva Vault vs Salesforce Life Scie

A detailed guide for IT on 21 CFR Part 11. Learn the FDA's rules for electronic records & signatures, including system validation, audit trails, & data integrit

Learn best practices for writing an effective FDA 483 response. This guide covers how to address inspectional observations and implement CAPAs to avoid a Warnin

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

An educational guide to pharmaceutical licensing deals. Learn key deal structures, including co-development, and financial terms like upfront payments, mileston

A detailed profile of Cognition Therapeutics (CGTX) analyzing its pipeline, financials, and lead drug CT1812, a sigma-2 modulator for Alzheimer's and DLB.

An educational guide to Veeva Vault certification. Learn about training paths for Business & System Administrators, exam costs, maintenance fees, and career ROI

Learn about HCP marketing in the pharmaceutical industry. This guide covers strategies, digital channels, omnichannel engagement, and key pharma regulations.

Explore Salesforce Health Cloud for biopharma. This in-depth guide covers its core CRM capabilities for patient engagement, clinical trials, and HCP relationshi

Learn the key updates in ISPE GAMP 5 Second Edition. Our guide covers the new focus on critical thinking, agile validation, cloud services, and CSA for GxP syst

An in-depth analysis of Merck's GPTeal, a secure generative AI platform. Learn how it uses LLMs to accelerate pharmaceutical R&D and boost productivity.