Pharmaceutical Industry Articles & Reports - Page 12

Learn what Investigator-Initiated Trials (IITs) are and the regulatory responsibilities clinicians face as a Sponsor-Investigator in academic clinical trials.

An educational guide to sample size calculation in clinical trials. Learn the roles of statistical power, effect size, and alpha/beta errors in trial design.

An analysis of cell and gene therapy logistics for clinical trials, covering supply chain challenges like the cryogenic cold chain, chain of identity, and trace

Explore the Bid Defense Meeting (BDM), a critical step for CROs to win clinical trial contracts. Learn key preparation strategies, sponsor criteria, and best pr

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

This guide defines Fair Market Value (FMV) for clinical trial investigator compensation. Learn key regulations like the Anti-Kickback Statute and Stark Law to e

Learn about entry-level clinical trial roles. This guide explains the Clinical Trial Assistant (CTA) and IHCRA positions, including responsibilities, salary, &

Learn how MedDRA and WHODrug standardize coding for adverse events and medications in clinical trials. This guide covers their structure, use, and best practice

Analyze the future of Contract Research Organizations (CROs) to 2030. Learn about market growth forecasts, the impact of AI, and decentralized clinical trial mo

Explore the evolution from paper CRFs to eCRFs for clinical trials. Compare paper vs. electronic data capture (EDC) on data quality, cost, time, and compliance.

Learn about the database lock process in clinical trials. This guide covers its importance for data integrity, the steps involved, and key team responsibilities

Learn the key factors CROs use for clinical trial site selection. This guide covers patient recruitment, feasibility assessments, and data-driven methods for su

Learn the complete query management process in clinical trials. This guide covers the workflow, high costs, and impact on data integrity for CROs and sites.

Explore the end-to-end Request for Proposal (RFP) process for clinical trial outsourcing. Learn best practices for sponsors to write and evaluate CRO bids.

A detailed analysis of clinical trial start-up costs, from IRB fees to site activation. Explore benchmarks, hidden expenses, and budgeting for sponsors and CROs

Compare ACRP vs. SOCRA clinical research certifications. This guide analyzes eligibility, exam content (ICH GCP), cost, and recertification for CCRC, CCRA & CCR

Learn how to manage protocol deviations in clinical trials. This guide covers classification, reporting, and prevention to ensure data integrity and GCP complia

Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. This guide clarifies definitions, causality, and expedited reporting timel

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 the essential CDISC standards for clinical trial data. This guide explains the SDTM and ADaM data models, their structure, and use in regulatory submissio

Learn what decentralized clinical trials (DCTs) are, how they work, and the technology involved. This guide covers the benefits, challenges, and future of DCTs.

An evidence-based comparison of digital vs. traditional clinical trial recruitment. We analyze cost-effectiveness, speed, conversion rates, and participant dive

Prepare for FDA BIMO inspections with this guide for clinical sites & CROs. Learn key strategies for documentation, QMS, staff training, & GCP compliance.

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