Ethical’s Cloud-based clinical endpoints adjudication management software eAdjudication® helps drug manufacturers achieve consistently accurate clinical trial results by simplifying assessment processes.
The company’s engineers and quality assurance (QA) experts design the software’s robust technology using decades of experience and proven deployment methodology to meet client requirements.
Robust GxP-compliant clinical endpoints adjudication technology
Ethical’s real-time adjudication platform transfers accurate and complete data from trial sites to clinical event committee members while meeting good practice (GxP) guidelines.
eAdjudication handles role-based access, workload balance, QA and disagreement resolution, which can be adjusted to meet the event committee’s specifications.
The system’s user-friendly interface makes eAdjudication easy-to-use for all stakeholders in the adjudication process. The platform’s performance management tools detect any third parties involved and removes any flaws from the process.
eAdjudication provides accurate archiving of produced materials, as well as robust data protection and control. Transient information is encrypted and all actions are captured in a full audit trail document, which can be protected using cutting-edge blockchain verification.
Management services for drug clinical studies
Ethical’s engineers have years of experience in designing and managing clinical studies involving endpoint adjudication.
The company customises its platform to meet each client’s adjudication charter specifications and operational environments, as well as other trial management requirements.
Ethical’s partnerships with academic research organisations and endpoint adjudication subject matter experts worldwide help the company assist clients in every step of the adjudication process. This ranges from charter design to committee members selection and management, review of safety reports / medical records, translation and anonymisation of clinical event package documents. It also covers consensus meetings scheduling / reporting, and archiving adjudication documents in the trial master file (TMF) / electronic TMF (eTMF).
Deployment methodology and software integration
Ethical’s efficient deployment process comprises charter analysis, system configuration, testing and validation, as well as delivery of drugs to the production environment.
The company designs workflows, forms and adjudication packages, alongside performing system configuration following the users’ requirement specifications (URS). It completes necessary software integration and customisation, creates users’ profiles, and designs forms / workflows.
Software configuration, training and maintenance
Ethical’s service covers eAdjudication software configuration, customisation, deployment, training, validation and technical systems maintenance.
The platform will be configured to accommodate multiple clinical studies to achieve economies of scale.
Ethical’s staff remain available throughout a study to train users and assist with any technical or clinical issues. The company continues to manage the system on a technical level by monitoring servers, ensuring a smooth and reliable operating environment.
Electronic adjudication management software and services
Ethical’s adjudication software has supported more than 300 international clinical trials at 10,000 investigator sites. The company understands the sensitive nature of its data services. Its solution was shaped around the idea of an endpoint adjudication management system that is easy-to-use and cost-effective.
Ethical’s eAdjudication provides:
- Unlimited role-based users
- Dossier collection from sites, redaction and assembling before submission environment
- Adjudication committee members management
- Adjudication forms with edit checks, workflows and major / minor disagreement management
- Query to site and re-submission management
- Real-time tracking and audit trail
- Integration of active pharmaceutical ingredients (API) and forms for medical records and events from sites and trial databases (MedidataRave / InForm / DICOM imaging / Medical Box)
- Standard / custom export of data/metadata in PDF, XML or SAS formats
Ethical helps clients achieve the necessary timelines and offers an all-inclusive price with no hidden costs.