Articles tagged with “drug-development”

Explore the Boston-Cambridge biotech ecosystem. This guide covers top companies like Biogen & Vertex, venture funding, and Massachusetts' drug development pipel

Learn how AI and machine learning analyze Real-World Data (RWD) to generate Real-World Evidence (RWE). Explore key applications, benefits, and challenges.

A guide to the Target Product Profile (TPP), a strategic document for drug development. Learn its components, purpose, and how to align it with the final drug l

Explore the rise of CRO consolidation in the clinical trials industry. This analysis covers M&A trends, key drivers, and the impact on pharma sponsors and quali

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

Learn about the EU Clinical Trial Regulation (CTR) 536/2014 and the CTIS portal. This guide covers harmonized submission processes, key timelines, and transpare

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

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

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

Explore the 2025 rare disease landscape, affecting 300 million people globally. Learn about diagnostic challenges, orphan drug development, and future policy di

Explore a comprehensive list of the top pharma news websites and biotech publications. Learn about sources for drug development, regulatory changes, and market

Learn how open source software like R and Python is changing pharma R&D. We analyze the shift from proprietary systems to collaborative drug discovery models.

Learn why over 85% of clinical trials face delays. This analysis covers the key scientific, operational, and regulatory challenges that slow drug progression.

A guide to finding drugs in the clinical pipeline (Phase I-III). Learn to use key resources like ClinicalTrials.gov, regulatory databases, and commercial tracke

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.

Learn about the specialized software tools used across the drug development lifecycle, from discovery and preclinical research to manufacturing and commercialization.

An explanation of Clinical Data Management (CDM) and its function in research. Learn how CDM ensures high-quality, reliable data for clinical trials.

Examines how AI accelerates the pharmaceutical drug pipeline, reducing time to market. Learn about its impact on preclinical testing, clinical trials, and manufacturing.

An overview of the pharmaceutical industry's history, from 19th-century origins to the current global market size, sales figures, and regional distribution.

Learn about 10 key AI innovations that optimize clinical trials, improving efficiency, reducing costs, enhancing patient safety, and speeding drug development.

Learn why new drug development takes over a decade, discussing the high attrition rates, extensive research, and regulatory hurdles involved in bringing medicines to market.

Explore profiles of top global pharmaceutical thought leaders, including their backgrounds, speaking topics, notable engagements, and industry influence.

A practical guide to clinical trial phases 1–3 for pharma IT: objectives, compliance, costs, and IT infrastructure for modern drug development.

An exploration of how artificial intelligence is revolutionizing drug development processes, from target identification to clinical trials, with focus on implementation strategies and success metrics.

An analysis of how artificial intelligence is transforming regulatory affairs in pharmaceuticals, from submission preparation to compliance monitoring and regulatory intelligence.

A comprehensive analysis of ChatGPT integration in life sciences, examining implementation strategies, regulatory compliance, and real-world applications across pharmaceutical research and development.

Comprehensive overview of Oracle's role in the pharmaceutical industry, covering their Health Sciences solutions, cloud infrastructure, compliance features, and case studies of successful implementations at major pharma companies.

A comprehensive analysis of how pharmaceutical companies leverage SAP's enterprise solutions for drug development, clinical trials, manufacturing, supply chain management, and regulatory compliance, with detailed case studies from leading pharma companies.

An in-depth analysis of the five most digitally innovative pharmaceutical companies in Europe, examining their AI initiatives, digital transformation strategies, and how they're leveraging technology to accelerate drug development and improve patient outcomes.