Case In Point
Top-tier Biometrics Provider for a Pediatric Neurodegenerative Study
About Client
A biotech company conducting a trial in the rare neurodegenerative space in a pediatric population needed a biometrics provider for its first interventional study.
Challenge
- A vulnerable pediatric population required strong data and safety surveillance.
- A first interventional study for the client meant the need for a very high-touch relationship with consistent, responsive, and transparent communication.
- There was also a need to build strong foundational materials and documentation standards.
Solution
Everest provided full support across multiple service areas and continued to scale as the sponsor’s needs grew. Services provided included:
- Data Management, Biostatistics and Programming: Delivered using Everest’s internal standards, helping the sponsor develop a strong, quality-focused study design. Database delivered on time.
- Functional Service Provider (FSP) Programmer: Provided to backfill internal team attrition and support exploratory programming for scientific conferences.
- Medical Writing: Supported development of clinical and regulatory documents.
- Safety Surveillance Support: Designed and implemented a program that included:
- Routine data reviews focused on pediatric safety
- Quarterly literature reviews
- Alignment with DSMB data to detect trends, safety signals, and identify needed improvements
- Document Standardization: Created standard templates for protocols, Investigator’s Brochures (IBs), and other core documents required for study execution and regulatory submissions.
- Leadership Engagement: Everest’s C-suite was directly involved early in the engagement to ensure high-quality execution of complex startup tasks.
- Team Stability: Maintained stable and consistent teams across all service areas.
Results
- On-Time Delivery: Study database delivered on time, with high-quality data design and execution.
- Robust Safety Oversight: Custom safety surveillance program supports ongoing pediatric safety monitoring and operational improvement.
- High Client Satisfaction: The sponsor has continued working with Everest for more than 2.5 years. The sponsor is very happy with the quality and effectiveness of Everest’s work.
