Application Notes & Case Studies

1. A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution 8/18/2025

   eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.

2. Targeted Indication Selection Using Adaptive Design 8/12/2025

   What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?

3. Advancing Dose Escalation Strategies With Bayesian Modeling 8/12/2025

   A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

4. Building A High-Quality IND From Scratch With Strategic Gap Analysis 8/12/2025

   A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

5. NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission 8/12/2025

   A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

6. Advancing Oncology Innovation With Adaptive Trial Designs 8/12/2025

   When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.

7. Rescuing A Global Program For NDA Success 8/12/2025

   Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

8. Removing Translation Bottlenecks With AI 8/8/2025

   See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.

    

9. Biometric Services For Large Pharmaceutical Company 7/31/2025

   This case exemplifies the effectiveness of flexible staffing solutions in meeting the dynamic needs of the biopharmaceutical industry while maintaining control over project deliverables and timelines.

10. Flexible Data Management For Growing Portfolio 7/31/2025

    Explore strategic enhancements to a small biopharma's biometrics capabilities involving the deployment of 20 specialized professionals, which effectively bolstered the client’s organizational capacity.