Pharmaceutical Industry Articles & Reports - Page 7

An in-depth comparison of the FDA and EMA. Learn the key differences in US and EU drug approval processes, review timelines, GMP, and regulatory frameworks.

A guide to the clinical trial protocol. Learn its core components, importance in research, and how to manage complexity and amendments for successful trials.

Learn why the drug development timeline averages 10-15 years. This guide details each stage from discovery and preclinical studies to all clinical trial phases

Learn about key clinical trial acronyms. This guide explains the definitions, history, and roles of GCP, ICH, IRB, EDC, and eTMF in clinical research.

Learn the key clinical research roles. This guide defines the responsibilities of the Principal Investigator (PI), CRC, CRA, and Clinical Project Manager in tri

Learn the critical differences between preclinical and clinical research in drug development, from lab-based toxicology (GLP) to human clinical trials (GCP).

Compare the two primary CRO business models: full-service (FSO) and Functional Service Provider (FSP). Learn the pros, cons, and key factors for choosing a mode

Explore the distinct roles in clinical trials. Learn the specific responsibilities of sponsors, CROs, and sites, from protocol design to regulatory compliance u

Learn what a Contract Research Organization (CRO) is and its critical role in modern drug development. This guide covers CRO services, benefits, and market tren

An in-depth guide to the four phases of clinical trials. Learn the objectives of Phase I-IV, from establishing drug safety and efficacy to post-approval studies

Learn the complete data cleaning process in clinical trials. This guide covers clinical data management (CDM) best practices, error detection, and regulatory co

A complete guide to clinical trial site close-out. Our checklist covers data integrity, IP accountability, archiving, and regulatory compliance per ICH-GCP & FD

Learn the technical requirements for GLP audit trails. This guide covers compliant file systems, immutable storage (WORM), and network shares for data integrity

Need GLP compliance software? Our guide reviews the top 5 systems for data integrity, 21 CFR Part 11, and audit trails. Compare top LIMS and QMS solutions.

Learn about 21 CFR Part 58, the FDA's Good Laboratory Practice (GLP) regulations for nonclinical studies. This guide covers its scope, history, and key subparts

A technical guide to creating a GLP-compliant audit trail on macOS. Learn to meet data integrity rules (21 CFR Part 11) using APFS, FSEvents & Endpoint Security

Explore the FDA Pre-license Inspection (PLI) process for biologics. This guide explains the PLI's purpose, scope, and cGMP requirements for BLA approval.

An educational review of top FDA compliance monitoring companies. Compare leading QMS software platforms and expert regulatory consulting firms for pharma & med

An overview of glial cells (neuroglia), the essential non-neuronal cells in the brain. Learn the functions of astrocytes, oligodendrocytes, microglia, and more.

Explore the state of Real-World Evidence (RWE) analysis. This guide covers RWD sources, key analytical methods, regulatory use cases, and compares RWE with RCTs

Most clinical trials face recruitment delays. This guide analyzes 10 leading patient recruitment services and software platforms used to accelerate trial enroll

An educational guide to leading pharmacovigilance service providers. Learn about the PV outsourcing market, regulatory drivers, and compare top drug safety CROs

Learn about biomarker testing coordination services in oncology. This guide covers key challenges, roles like patient navigators, and solutions for precision me

Learn about the medical writing and scientific publication planning industry. This guide covers market size, key services like regulatory writing, and GPP guide