Trial Oversight

Arithmos – Comprehensive Trial Oversight Solutions for Clinical Development 

Regulatory Imperatives for Oversight 

In accordance with the Good Clinical Practice (GCP) guideline ICH E6(R3), issued by the International Council for Harmonisation (ICH), pharmaceutical and biotechnology companies are required to ensure structured, pharmaceutical and biotechnology companies are required to ensure structured, comprehensive, and documented oversight of their clinical trials. This requirement emphasizes the sponsor’s responsibility to maintain robust control over trial processes, whether outsourced to CROs or conducted in-house, in order to ensure patient safety, data integrity, and compliance. 

This evolving regulatory landscape has created a need for proactive oversight strategies that are not only compliant but also efficient, scalable, and technology-enabled. 

Arithmos’ Holistic Approach to Trial Conduct Oversight 

At Arithmos, we recognize that clinical oversight is not just a regulatory requirement—it is a critical element of risk mitigation, operational excellence, and stakeholder trust. That’s why we have developed a holistic approach to Trial Conduct Oversight, which supports sponsors across the entire oversight lifecycle. 

Our services are designed to help clients: 

• Design a tailored oversight strategy aligned with regulatory expectations and study-specific needs. 

• Gather and define business and technical requirements to enable optimal oversight solutions. 

• Identify, select, and implement enabling technologies that support centralized and risk-based oversight. 

• Maintain oversight tools and systems, ensuring they remain validated, current, and effective throughout the trial lifecycle. 
• Execute business processes related to vendor management, performance tracking, issue management, and regulatory documentation. 

Our Oversight Services Portfolio 

Arithmos offers a suite of integrated services that enable a proactive and quality-driven oversight framework: 

1. Oversight Strategy Consulting 

• Risk-based and centralized monitoring strategy definition 

• Gap analysis of current oversight capabilities 

• Oversight governance model design 

2. Technology Enablement 

• Requirements gathering for oversight platforms  

• Vendor assessment and tool selection (e.g., CTMS, eTMF, RBM tools) 

• Implementation, integration, and validation of oversight systems 

3. Operational Execution Support 

• Trial performance metrics setup and analysis (KPIs/KRIs) 

• Vendor oversight through CTA provisioning 

• CTMS and eTMF support provisioning 

• Support in the Digital Trial execution 

4. Quality & Compliance 

• Audit preparation and response support 

• Regulatory submission readiness 

• Ongoing compliance monitoring and documentation support