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.

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Challenge

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.

Key requirements

  1. 21 CFR Part 11‑compliant

  2. Developed according to GAMP 5

  3. Validated system

  4. High performance & short response time

  5. Secure and cloud-based

  6. Data sharing by many users

Solution

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.

Learn how we help a Scandinavian biotech company develop oncolytic immunotherapies by transferring PET-CT scans in a phase I trial.​

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IMAGE IMPORT

Images are imported to SliceVault from one or more investigator sites.

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IMAGE EXPORT

Images are exported by trial sponsor.

QUALITY ASSURANCE

Images are scanned for correctness and compliance.

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CENTRAL READ

Blinded central read by trained clinician.

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CENTRALIZATION

Images are stored centrally on secure servers.

DE-IDENTIFICATION

Images are stripped from personal health information.

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QUALITY CONTROL

Manual quality control by trained professionals.

TRACK & QUERY

Track image status, and open and resolve queries within the system.

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