MINERVATE
We combine cutting-edge technology with deep pharmaceutical expertise to deliver solutions that accelerate your path to market while ensuring the highest standards of compliance and quality.
Minervate values 'patient safety, quality and integrity' and delivers comprehensive solutions across the entire clinical trial lifecycle.
Excellence in every aspect of pharmaceutical development
In Compliance Solutions with proven track record across global markets
Safety and Quality excellence that exceeds regulatory requirements
For Every Phase of Development, customized to your specific needs
Comprehensive support from study initiation to closeout
Clinical Trial Management
Minervate's clinical trial management system aims to plan, manage and track the operational aspects of clinical trials studies from start to finish, with the aid of its Electronic Data Capture system.
Comprehensive preparation for successful trial execution.
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 the trial master file (eTMF) for the sponsor and the investigator file (eISF) for the site.
Budget and Resource Management
Minervate's CTMS has the ability to track and standardize budget templates, manage contracts, and consult on the allocation of resources effectively across trial sites.
Minervate facilitates the data collection methods of Case Report Forms (CRFs) and Electronic Case Report Forms (ECRFs), alongside the use of Electronic Data Capture (EDC).
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.
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).
Trust and regulatory excellence are at the foundation of everything we do. Minervate maintains the highest standards of compliance across all major regulatory frameworks.
Experience the Minervate difference in clinical trial excellence.