Clinical Operation Services
Trial Monitoring and Management
Study Monitoring & Site Management
Precision. Partnership. Performance
Robust site monitoring and proactive management are the backbone of every successful clinical trial. At Nexus Pharma Group, we deliver end-to-end oversight services that ensure your study runs smoothly, safely, and in full compliance—from site qualification to final close-out.
With a sharp eye for detail and a commitment to excellence, we help sponsors and CROs maintain data integrity, regulatory readiness, and high-performing site relationships across all trial phases.
From study startup to close-out, we provide comprehensive oversight to ensure every site operates efficiently, remains protocol-compliant, and is always inspection-ready
Site Qualification & Initiation
- Assesses site capabilities, infrastructure, and staff readiness for study participation
- Provides tailored training for investigators and site staff
- Supports seamless study/site activation and enrolment
Interim Monitoring
- Conducts on-site and remote monitoring visits
- Ensures adherence to protocol, ICH-GCP, and regulatory standards
- Identifies risks early and implements corrective actions
Close-Out Support
- Manages final data reconciliation
- Oversees archiving of essential documents
- Ensures compliant site closure
Ensuring compliance is at the core of every successful clinical trial. We help sites maintain strict adherence to ICH-GCP, protocol requirements, and regulatory standards, safeguarding data integrity and participant safety throughout the study
Ongoing Site Monitoring
- Regularly reviews site activities to ensure full alignment with ICH-GCP, study protocols, and applicable regulatory requirements.
Early Issue Detection
- Identifies deviations or non-compliance promptly and implements corrective and preventive actions to minimize impact on study quality.
Training & SOP Reinforcement
- Provides continuous education and reinforces standard operating procedures to prevent recurring issues and maintain consistent high standards across all sites.
Regulatory Readiness
- Supports sites in maintaining audit-ready documentation and inspection preparedness at all stages of the trial.
Accurate, reliable, and compliant data are the foundation of every successful clinical trial. We provide end-to-end data management and quality assurance services to ensure that clinical trial data are complete, traceable, and audit-ready throughout the study lifecycle.
Comprehensive Oversight
- Provides full support to ensure the accuracy, integrity, and compliance of clinical trial data.
Source Data Verification (SDV)
- Confirms that Case Report Forms (CRFs) and Electronic Data Capture (EDC) entries accurately reflect source documentation, ensuring early discrepancy detection and complete data traceability.
Query Management
- Works with site staff and data managers to monitor and resolve queries promptly in line with study protocols and data management plans.
Data Entry Quality
- Oversees data entry timelines and quality metrics to maintain completeness, consistency, and database integrity.
Database Lock Support
- Assists sponsors during final data cleaning, reconciliation, and database lock to ensure all data are validated for analysis.
Audit-Ready Documentation
- Maintains detailed records of data reviews and query resolutions to support audits and inspections.
Global Compliance
- Adheres to ICH-GCP, GDPR, HIPAA, and other international standards to ensure data reliability and regulatory compliance.
Strong, collaborative site relationships are key to achieving high-quality data and successful study outcomes. We focus on building trust, enhancing communication, and supporting sites to perform at their best throughout the clinical trial.
Investigator & Coordinator Engagement
- Cultivates strong partnerships with site staff to encourage collaboration, accountability, and active participation in the study
Efficient Communication
- Acts as a liaison between sites, sponsors, and CROs to streamline information flow, clarify expectations, and resolve issues promptly
Operational Support
- Assists sites in achieving enrolment targets, maintaining data quality, and adhering to protocol and regulatory requirements
Performance Monitoring & Feedback
- Provides ongoing guidance, feedback, and training to ensure continuous improvement and high-performing site relationships
Accurate, timely, and compliant documentation is essential to the success of every clinical trial. We ensure all records are meticulously maintained, clearly communicated, and fully inspection-ready.
Monitoring Visit Reports
- Prepares detailed visit reports and follow-up letters that clearly document site performance, findings, and any required actions
Regulatory Documentation
- Maintains accurate and up-to-date regulatory files in alignment with sponsor SOPs and applicable guidelines
Version Control & Audit Readiness
- Ensures all documents are properly version-controlled, securely stored, and ready for audits or regulatory inspections
Transparent Communication
- Provides stakeholders with clear, actionable reports that support informed decision-making and continuous study oversight
Efficient, compliant, and audit-ready document management is critical for successful clinical trials. We ensure all essential trial documentation is accurately maintained, easily accessible, and fully inspection-ready.
Comprehensive Document Tracking
- Manages Trial Master File (TMF) and Investigator Site File (ISF) documents in both electronic and paper-based systems, ensuring completeness and proper filing
Ongoing Quality Reviews
- Conducts periodic audits to identify missing or outdated documents, addressing gaps proactively to maintain compliance
eTMF Support
- Facilitates real-time document uploads, indexing, and version control on electronic TMF platforms, ensuring efficient access for sponsors and study teams
Regulatory Readiness
- Maintains a fully audit-ready filing system that supports sponsor inspections and regulatory submissions
Patient safety is our top priority. We ensure accurate, timely, and compliant reporting of all safety events
Timely Reporting
- Document and report Adverse Events (AEs) and Serious Adverse Events (SAEs) per protocol and regulatory timelines.
Regulatory Compliance
- Adhere to global safety regulations and Good Clinical Practice (GCP) standards
Training & Guidance
- Provide teams with guidance on AE/SAE identification and reporting.
Safety Summaries
- Prepare clear reports for sponsors and regulatory authorities.
Quality Checks
- Ensure accuracy and completeness in all safety documentation.
Every deviation tells a story—we ensure it is thoroughly documented, analyzed, and resolved
Detailed Documentation
- Monitor the implementation and effectiveness of Corrective and Preventive Actions (CAPA) to ensure timely resolution.
Audit & Inspection Readiness
- Prepare clear summaries and reports for audits, inspections, and regulatory reviews
Trend Analysis
- Identify recurring issues and patterns to drive continuous process improvement
Regulatory Compliance
- Ensure all deviation management processes align with regulatory standards and Good Clinical Practice (GCP).
Team Guidance & Support
- Provide guidance to study teams on documenting deviations and executing CAPA effectively.
Confidence under scrutiny—we prepare your sites to succeed during every audit and inspection.
Pre-Audit Reviews
- Conduct thorough assessments and mock inspections to identify gaps before official audits.
Documentation Compliance
- Ensure all study documentation is complete, accurate, and fully compliant with regulatory standards.
On-Site & Remote Support
- Provide real-time guidance and support during regulatory inspections, either on-site or virtually
Regulatory Preparedness
- Keep sites up-to-date on changing regulations and inspection expectations.
Continuous Improvement
- Analyze audit findings to implement corrective actions and enhance future compliance readiness.
Team Training
- Equip site staff with practical tools and training for audit and inspection success.