TrialStat

TrialStat® develops and delivers on-demand data solutions for pharmaceutical, biotechnology, and medical device companies, as well as Contract Research Organizations (CROs) and data management companies. The company's flagship offering, the TrialStat eClinical Suite™, combines Electronic Data Capture (EDC), a Reporting Portal, and a Vendor Neutral Imaging Archive into a single integrated platform designed to support clinical trials across all therapeutic areas, from pilot and proof-of-concept studies through Phase I, II, III, and IV.

TrialStat EDC is a scalable, hosted system accessible via any web browser or mobile device. It is designed to reduce study build time, improve data capture accuracy, and lower overall study costs. The platform is positioned as suitable for standard pharmaceutical and biotechnology trials as well as the specific requirements of medical device and diagnostic studies.

TrialStat EDC — Core Modules

• eConsent: Supports configurable consent workflows including witness consent, assent, re-consent, and patient revocation of consent. Designed to accelerate trial enrolment and improve protocol compliance. Can be used integrated with TrialStat EDC or as a standalone module with other EDC platforms.
• Electronic Patient-Reported Outcomes (ePRO / eCOA): Enables electronic collection of patient-reported outcome and clinical outcome assessment data as part of the unified EDC suite.
• Randomization / IWRS: Interactive Web Response System functionality for randomization and supply management, integrated directly within the EDC platform.
• Pharmacovigilance – Adverse Events (AEs) and Serious Adverse Events (SAEs) Management: Dedicated module for tracking and managing adverse and serious adverse events within the clinical trial workflow.
• Medical Coding Module: Provides medical coding capabilities as part of the unified eClinical suite.
• Regulatory Compliance: The platform includes features and configurations to support regulatory compliance requirements for clinical trial data.

Additional Platform Components

• Vendor Neutral Imaging Archive: A component of the eClinical Suite that provides imaging data storage and management independent of specific imaging vendors.
• High Speed Private Cloud: TrialStat offers a high-speed private cloud deployment option for hosting the eClinical Suite.
• Reporting Portal: Included as part of the broader eClinical Suite to support data reporting and oversight across studies.

Services Offered

• Study Design and Configuration: Assistance with designing and configuring studies within the platform, including eCRF build and data migration support.
• Project Management: Dedicated project management support from database build through database lock.
• End User Training: Training services for study site and sponsor users of the platform.
• Rescue Studies: Services for taking over and stabilising studies that have encountered difficulties with other platforms or vendors.
• Randomization and Supply Management: Managed services for trial randomization and investigational product supply management.
• Custom Software Development and Validation: Development of custom software solutions and associated validation services for clinical trial needs.

Customers and Notable Details

• TrialStat serves pharmaceutical, biotechnology, and medical device companies, as well as CROs and data management organizations.
• The platform supports virtual and decentralized clinical trial models, as reflected in the company's positioning around enabling virtual clinical trials.
• Plus Therapeutics is cited as a client, with their Director of IT noting the platform's support for complex eCRF customization and data migration, and describing TrialStat as a reliable, scalable partner during a transition from manual processes.
• TrialStat partners with Contract Research Organizations, with a dedicated CRO partnership program referenced on the company's website.

TrialStat positions its eClinical Suite as a unified alternative to assembling separate point solutions for EDC, IWRS, ePRO, and coding, with the stated goal of delivering consistent quality on time and within budget from study initiation through database lock.