Zelta

Zelta is a unified clinical data management and acquisition platform designed for biopharma companies, medical device firms, CROs, and university institutions. It provides a no-code, modular environment that allows data management teams to independently design, build, and manage clinical studies across all phases without relying heavily on vendor support. The platform has been used by more than 200 organisations globally, supporting over 4,600 trials launched and more than 1.3 billion clinical data points collected.

At its core, Zelta offers an Electronic Data Capture (EDC) system combined with a suite of optional modules that can be selected and configured based on the specific requirements of each trial. The platform operates on a single code base with true single sign-on, ensuring all users and trials run on the latest version of the software. It supports more than 70 languages and dialects, enabling global site and patient engagement.

Study Design and Data Management Capabilities

• No-code study designer that allows data managers to build and modify studies independently, reducing build cycles by two or more weeks.
• Advanced logic builder with the ability to reuse study objects from current trials, previous trials, or Zelta's own library.
• CDM with Study Design Assistant AI to reduce the time required to design and standardise CRFs and accelerate study startup.
• Real-time AI-assisted edit checks to support interoperability across modules.
• Query management tools to identify and resolve data discrepancies efficiently.
• Medical coding with AI to streamline the coding process, improve accuracy, and support regulatory compliance.
• Local labs module to standardise lab data across sites where frequent sampling and fast results turnaround are required.
• Reporting and analytics to surface actionable insights from study data.
• Data integration module that supports building and automating data connectors with third-party solutions using minimal coding.

Participant and Provider Engagement Modules

• eCONSENT for remote consent delivery without requiring additional integration.
• eCOA/ePRO for direct participant and caregiver engagement through in-app assessments and real-time analysis.

Clinical Operations Modules

• Randomization and Trial Supply Management to streamline supply and randomisation processes.
• Globalization module to ensure site data collection and ePROs are accessible, accurate, and compliant across multiple languages and regions.
• eLearning module for electronic management of study training to support regulatory compliance.
• Endpoint Adjudication to design, assign, and automate adjudication workflows within a single workspace.
• Monitoring tools to focus resources on the most critical aspects of a study.

Ecosystem Partner Integrations

• BSI CTMS/eTMF
• Transperfect instrument licensing
• LedgerRun payment solutions
• Almac clinical supply
• Yunu DICOM imaging
• Additional partners accessible via plug-and-play APIs

Services Offered

• Advisory: Expert consulting to improve efficiency across clinical database delivery, support compliant database delivery at scale, enable end-to-end clinical data flow, and convert database metrics into actionable insight.
• Enablement: Training services including facilitated study build sessions, implementation support for new modules and functionality, role-specific training, and free multi-client sessions.
• Delivery: Study Build Services providing support for full or partial study builds, study design standardisation, and on-demand capacity to address resource gaps.
• Care: Global support available 24/7/365 via email, phone, and text.
• Partnership: Dedicated account managers providing regular check-ins and long-term client advocacy on product enhancements and process updates.

Platform Architecture and Compliance

• Hosted on a HIPAA-enabled cloud with single sign-on access across all modules and reports.
• Single instance technology ensures all trials and users remain on the latest version of the codebase.
• Certified and compliant with ISO 9001:2015, ISO 27001:2022, ISO 27701:2019, ISO 27017:2015, and ISO 27018:2019.
• Compliant with 21 CFR Part 11 and applicable data privacy regulations.
• Modular commercial model allows organisations to pay only for the modules they use, either at the study level or configured as a standard portfolio-level setup.

Zelta provides direct control over study go-lives, protocol amendments, study design changes, and study closeouts. All 20 of the top pharmaceutical companies have used the platform, and it is trusted across biopharma, medical device, CRO, and academic research settings worldwide.