Leveraging Technology for Drug Development

Minervate EDC

Minervate has developed an AI-driven patent-protected secure Electronic Data Capture (EDC) SaaS platform to suit the ever-changing demands of clinical trial research. Our system will be used to collect and manage data for investigator sites, patients and laboratories.

Minervate EDC streamlines data, improve data collection accuracy and maintains compliance with regulatory standards.

Benefits of EDC in Clinical Trial

Acceleration: We will accelerate your drug product to patients, by reducing time spent on data entry, manual processing, and data collection.

Accuracy: Our platform prides itself on strong accuracy and the minimisation of errors by using automated validation checks, data consistency rules, and real-time data entry.

Regulatory Compliance: Dedicated to meet regulatory requirements by providing audit trails, data security, data integrity and traceability.

Data Management: Minervate values the smoothness and transparency of data collection, our EDC would allow for high-quality centralized data storage, easier data access for analysis, and faster decision-making.

Data Collection and Management

Minervate EDC facilitates the data collection methods of Case Report Forms (CRFs) and Electronic Case Report Forms (eCRFs). With our AI-driven features, which allows integration with other systems, testing, query management, access control, automated validation to ensure accuracy, efficiency, and regulatory compliance

A man in white lab coat holding papers near three monitors.

A close up of many different types of pills

Clinical Trial Management

Minervate values ‘patient safety, quality and integrity’ and as such our system plans, manage and track all operational aspects of the clinical trials studies from start to finish.

Study Setup

Protocol Management: Minervate’s CTMS allows for the creation, review, and updating of the clinical trial protocol, ensuring all involved stakeholders are working with the most current version and adhering to the appropriate regional protocol in which they operate.
Site Selection and Management: Minervate’s speciality helps to identify and select appropriate clinical trial sites, site initiation consultation , and manage site-specific details such of site capabilities, and patient recruitment data.
Documentation: Minervate adheres to the International Council for Harmonization (ICH) and facilitates the drafting of study database design and set-up documentation, ensuring that your study meets set timelines.
Budget and Resource Management: Mineravte’s CTMS has the ability to track and standardize budget templates, manage contracts, and consult on the allocation of resources effectively across trial sites.

Three doctors are sitting at a table with papers.

Study Conduct

During the operations of the clinical trial study, Minervate can aid the monitoring of site performance and ensure GCP compliance, accurate documentation and reporting, and data collection and management. Tracking adverse events (AEs) and serious adverse events (SAEs), ensuring they are reported in a timely and accurate manner. Whilst simultaneously conducting internal audits and prepare for external audits or regulatory inspections.

Study Close-Out

Minervate is able to facilitate with the close out of a clinical trial study, by ensuring that all of the study data has been correctly and accurately compiled and analysed. And that the study reports and documentation are prepared according to regulatory requirements and ensure its readiness for final regulatory submission. Finally conducting a final internal audit and close out the Trial Master File (TMF).