FEATURED ARTICLES

• Delivering Successful Cell And Gene Therapy Trials

  Successfully executing complex cell and gene therapy trials hinges on meticulous operational strategies and a patient-centric approach.

• Designing Successful Cell And Gene Therapy Trials

  Designing cell and gene therapy trials requires specialized strategies to navigate unique complexities, ensuring successful and compliant development.

• Best Biostatistics Practices To Drive Clinical Trial Success

  Utilize this checklist of best practices for biostatistics in clinical trials, from early planning to regulatory submission.

• The Path Forward In Oncology Trials

  A comprehensive site support model is crucial for navigating the complexities of modern oncology trials and accelerating drug development.

• Creating Operational Efficiency And Competitive Edge

  Site networks offer a strategic approach to oncology clinical trials by accelerating study startup and expanding access to diverse patient populations.

• Strategic CMC Considerations For Pre-IND Meetings: Setting The Stage For A Successful TPP

  In biotechnology, the Pre-Investigational New Drug (Pre-IND) stage is a critical juncture. Explore the pivotal role of Chemistry, Manufacturing, and Controls (CMC) in navigating this phase.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• How To Reduce Barriers And Improve Trust In Complex Clinical Trials

  This guide explores how family and patient-centered trial design can transform participation, including key strategies such as early, transparent communication, emotional check-ins and flexible protocols.

• Key Updates To Implementing Regulation (EU) 520/2012

  The evolving pharmaceutical landscape demands continuous regulatory adaptation to safeguard patient safety and ensure compliance.

• Top 9 AI Implementation Strategies For Pharmacovigilance

  By following these nine strategies, organizations can implement AI in pharmacovigilance responsibly, ensuring systems that are aligned with the goal of improving patient safety and public health outcomes.

• Transforming First-In-Human Oncology Trials: A Strategic Guide

  Drawing from extensive experience in early-phase oncology, this guide offers a strategic framework for executing first-in-human (FIH) oncology trials with a patient-centric and risk-based approach.

• Effective Engagement Strategies With Patient Advocacy Organizations

  Collaboration between drug development companies and Patient Advocacy Organizations is essential to bridging gaps between stakeholders and advancing rare disease research.

• Optimizing Oncology And Rare Disease Clinical Trials

  Dive into the history and accomplishments of Ergomed, a mid-sized, full-service contract research organization (CRO), with a specialized focus on oncology and rare disease clinical research.

• The Future Of Oncology Research: Trends And Predictions

  In a clinical trial landscape defined by innovation and empathy, oncology CROs are essential to shaping the future of cancer research.

• Navigating The Complex World Of First In Human Oncology Trials

  First-in-human oncology trials are critical touchpoints in the development of novel cancer therapies, requiring precise scientific execution and a deeply patient-centric approach.

• Patient-Reported Outcome In Oncology Clinical Trials

  As cancer therapies grow more complex and personalized, patient-reported outcomes (PROs) have emerged as a vital component of oncology research and care.

• Navigating The 7 Biggest Challenges In Rare Disease Clinical Trials

  Discover how partnering with specialized rare disease CROs allows drug sponsors to accelerate treatment development, navigate trial complexities, and ultimately improve patient outcomes.

• Reimagining Medical Monitoring In Clinical Research

  Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.

• The New Era Of Medical Monitoring

  Examine the transformative landscape of medical monitoring in clinical trials with an emphasis on the shift from conventional retrospective reviews to a proactive, risk-based methodology.

• Key Strategies For Clinical Development In Rare Cancers

  Successful execution of rare cancer clinical trials requires strategic patient recruitment, innovative trial design, and specialized expertise from Oncology CROs.