Streamline data management in decentralized phase III trials
How we help an international biotech company to streamline their data collection, quality assurance, and central read procedures in a large decentralized phase III trial.
With more than 40 compounds in development, this client was looking for a flexible solution to streamline image management in several imaging-based clinical trials.
The client was engaged in many imaging-based clinical trials, ranging from small pre-clinical to large decentralized phase III trials, where thousands of medical images were collected and analysed.
The client was now looking for a highly versatile solution to streamline image management across trials from image upload to image export. The ideal solution should enable swift data collection (upload), patient de-identification, automated quality control (QC), manual QC, querying, image viewing, facilitation of central reading, role-based access to data and functionality, support different user-roles such as investigators, monitors, QC managers, project managers, trial coordinators, etc.
For a phase III efficacy trial, we helped this client to transfer, quality assure, and facilitate central reading of thousands of MRIs in a large decentralized phase III trial.
21 CFR Part 11‑compliant
Developed according to GAMP 5
High performance & short response time
Secure and cloud-based
Data sharing by many users
Together with the client we went over all their requirements (quality requirements, security requirements, documentation requirements, user requirements, functional requirements, non-functional requirements, system requirements and more) and designed an intuitive workflow that meet all their needs.
Images are imported to SliceVault from one or more investigator sites.
Images are exported by trial sponsor.
Images are scanned for correctness and compliance.
Blinded central read by trained clinician.
Images are stored centrally on secure servers.
Images are stripped from personal health information.
Manual quality control by trained professionals.
TRACK & QUERY
Track image status, and open and resolve queries within the system.