Customer success story

How MedaSystems helped a biotech cut Expanded Access response times from four days to one.

CLIENT

A US-based publicly traded biotechnology company developed two late-stage, Phase 3-ready therapeutics to treat solid tumors. 

THE CHALLENGE

Following the release of promising clinical trial data, the company faced an overwhelming influx of expanded access requests. The operations team encountered significant difficulties in adhering to internal procedures and regulatory requirements while relying on their existing systems, which included email, PDF forms, and spreadsheets. This fragmented approach led to inefficiencies, increased the risk of errors, and hindered effective communication.

The company recognized the urgent need for an end-to-end solution that could:

  • Centralize Information: Store all relevant data related to each request in a single, accessible platform.

  • Enhance Communication: Facilitate more efficient and streamlined communication between physicians and research staff.

  • Ensure Compliance: Meet regulatory standards and internal protocols without compromising speed or accuracy.

Addressing these challenges was crucial for managing the growing volume of requests while maintaining high standards of compliance and operational effectiveness.

RESULTS

The implementation of MedaSystems transformed the organization's process, delivering substantial improvements across multiple dimensions:

Operational Efficiency

  • Achieved a 75% reduction in request processing time

  • Streamlined workflow visibility across all team members

  • Eliminated bottlenecks through real-time status tracking

Process Digitization

  • Converted manual, confusing workflows into structured digital processes

  • Implemented customized digital forms and automated routing

  • Created a centralized platform for consistent data capture and storage

Enhanced Transparency

  • Provided real-time visibility into case status and progress

  • Enabled team members to access collected materials and data instantly

  • Established clear tracking of decision-making stages

Compliance & Auditability

  • Implemented comprehensive task-tracking mechanisms

  • Created structured data storage with easy retrieval capabilities

  • Established clear audit trails for all processes and decisions

The new system fundmentaly transformed expanded access requests, replacing a previously complex and opaque process with a streamlined, transparent, and efficient digital workflow management solution.