WHITE PAPERS AND CASE STUDIES

• Meeting The FDA's New Real-World Evidence Standards

  FDA guidance is reshaping RWE strategy. Sponsors that build interoperable, audit-ready RWD infrastructure now will be best positioned for faster, defensible submissions.

• Addressing A Global Health Priority In Australia And New Zealand

  For sponsors navigating a competitive therapeutic landscape, this case underscores how regional execution excellence can accelerate global impact.

• Phase IIb Trial: Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer

  This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• How To Recruit 236 Patients In An Osteoarthritis Study On Time During The Peak Of The Pandemic

  A leading Eastern European contract research organization completed the recruitment of 236 subjects in a Phase 3 osteoarthritis study for Handok Inc. despite hurdles caused by the COVID-19 pandemic.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

  A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

• The Strategic Advantage Of eCOA And IRT

  The future lies in unified, interoperable eCOA–IRT solutions that streamline operations, improve data integrity, and enhance patient and site experience.

• Streamlining European Expansion With Integrated PV, Regulatory, And Commercial Expertise

  See how a single-provider model integrated pharmacovigilance with regulatory and commercialization support to support a scalable, audit-ready system that strengthened compliance and freed internal resources for growth.

• Faster Starts, Stronger Finish: Operational Excellence In NSCLC

  In NSCLC trials, data‑driven site selection, streamlined protocols, efficient screening strategies, and proactive engagement can accelerate enrollment and improve trial efficiency across regions.

• Human-Centered RTSM Design Enhances Data, Safety, And Operations

  Uncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.