Data Quality, Security & Compliance
Value through enhanced decision making
Simbec Orion is focused on providing clear value to our sponsors through our technology and data strategy – ensuring that we deliver value through enhanced decision-making, operational efficiency, and partnerships with best-in-class providers. We have enabled a robust data governance structure ensuring data quality, security, and compliance with regulations including GDPR.
With this strong focus on security, continuity, and data integrity we leverage industry-leading technology to underpin our commitment to delivering high-quality, robust data through systems that remain scalable to meet all project needs.
Oracle Inform
Oracle Inform is a world leader in EDC databases for clinical trials which allows easy access to real-time study data, including reporting. As a web-based system, no installation is required, and the medical coding tool integrates directly into the eCRF.
Veeva Vault Clinical
Veeva Vault Clinical is a web-based cloud application that enables real-time management and oversight of clinical trial processes, improved operational efficiency and streamlining collaboration and integration with clinical trial documentation.
The platform has been designed specifically for the life science industry, offering great flexibility and visibility for sponsors, additional CRO site staff and study monitors.
Comprising of Veeva CTMS (Clinical Trial Management System), Veeva Vault eTMF (electronic Trial Master File), and Veeva Vault eQMS, each element has been designed and validated by Veeva to interact seamlessly.
LifeSphere MultiVilgilance
Aris Global’s LifeSphere MultiVilgilance (LSMV) is a cloud-based system which has been developed with input from life science organisations to provide an automated adverse event processing platform. Using cognitive computing technology and machine learning to reduce manual input, it accelerates case processing while ensuring patient safety and consistent compliance.
Clinspark®
ClinSpark® allows Simbec-Orion to accelerate study operations through simplified setup, real-time e-source data capture, and automated workflows. By providing immediate access to study data, we empower our clients to make faster, informed decisions.
Key benefits for our clients include:
- Efficient & targeted volunteer recruitment
- Simplified study setup & adaptive protocol development
- Optimised operations through eSource & automation
- Accurate data capture at source
- Enhanced sample tracking & LIMS integration
- Streamlined data management
- Regulatory compliance & inspection readiness
- Improved volunteer safety
These advanced capabilities enable clients to achieve their scientific objectives, meet regulatory milestones, and inspire confidence among investors and stakeholders. With ClinSpark®, Simbec-Orion reaffirms its position as a leader in clinical trial innovation, delivering excellence at every step of the research journey.
ThoughtSphere
We have cemented our data strategy through our partnership with ThoughtSphere, a cloud-based, integrated clinical data platform that enables us to unify our data from sources including eDC (Simbec-Orion’s Oracle Inform, or any sponsor study-specific eDC), our CTMS (Veeva CTMS) and laboratory data (from any lab provider) in the Clinical development space.
ThoughtSphere allows us to utlise AI to automate basic data management processes, accelerate data cleaning and reconciliation and, leverage their workflows and visualisation to streamline medical reviews.
Harnessing the potential of AI enables Simbec-Orion to become more efficient, ensure compliance, enhance ongoing data surveillance, and ultimately deliver high quality data, faster. Our clients also benefit from:
- Real-time data access, review and visualisation
- Self-service reporting (subject to data access authorisation
