White Papers

1. Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations 6/27/2025

   This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

2. Disclosure Management System: Build Or Buy? 6/19/2025

   Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

3. Completed Clinical Trials Continued To Climb In 2024 6/19/2025

   Data collected in this report reflects a shift toward sustained growth, reflecting rapid advancement in therapeutic areas such as oncology, autoimmune/inflammation, and central nervous system studies.

4. How Sponsors Can Drive Success With Central eSource At Investigator Sites 6/17/2025

   Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.

5. Immunohistochemistry In Precision Medicine: From Biomarker To Clinical Trial Assay 6/17/2025

   From preclinical validation to clinical implementation, immunohistochemistry (IHC) is essential in understanding target biology and ensuring drug safety and efficacy.

6. Leveraging AI To Transform Neurodegenerative Drug Development 6/11/2025

   Explore how AI is redefining the development pipeline for neurodegenerative diseases (NDDs), offering a path forward in the quest for effective, disease-modifying treatments.

7. Wearables For Optical Cardiovascular Monitoring 6/10/2025

   Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).

8. Deriving Reliable Clinical Outcome Scores From Continuous DHT Data 6/10/2025

   DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.

9. Optimizing Site Activation To Accelerate Clinical Trials 6/5/2025

   Clinical trial site activation delays are a major bottleneck in drug development, hampering trial timelines and funding flows. To reverse this trend, site-focused solutions are being prioritized.

10. Designing More Representative Trials Through Strategic Planning 5/28/2025

    Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.