FEATURED ARTICLES

• Gene Therapies For Rare Diseases: Advances In Platforms, Modalities, And Delivery Systems

  Examine the treatment landscape for rare diseases and the rapid evolution of gene therapy across three key dimensions: editing platforms, delivery modalities, and delivery vehicles.

• Why Inclusive Clinical Trials Win On Science, Speed, And Spend

  Sponsors who proactively integrate diversity into their trial designs from the earliest phases are finding that it’s not only a matter of fairness but a strategic advantage.

• How High-Performing Trials Operationalize Health Equity Early

  Explore how embedding inclusion early in clinical development enhances enrollment, strengthens data integrity, and improves outcomes, especially in oncology and rare disease trials.

• The Strategic Role Of Biostatistics In Clinical Trials

  Early biostatistical input strengthens trial design, reduces risk, and ensures meaningful outcomes while strategic involvement drives smarter decisions. Learn why timing and collaboration matter.

• Understanding Trauma And Support In Clinical Trials

  Trauma shapes how families engage with clinical trials, influencing adherence, decision-making, and data quality. Explore how a patient-centered, empathetic approach is essential to build trust.

• Site Management Support To Investigational Sites

  Rare disease trials demand specialized site support. Explore how tailored site management practices can improve consistency, data quality, and patient engagement in complex clinical studies.

• Prioritizing Patient Voices

  Patient-reported outcomes are redefining how rare oncology trials measure therapeutic impact. Explore how they offer insight into patient experience to improve engagement and guide research.

• Pre-IND CMC Checklist For Regulatory Success

  Learn how to prepare CMC documentation that meets regulatory expectations, and explore key elements for a successful Pre-IND submission to avoid common delays in the review process.

• 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.