Services

Clinical Data Management

Comprehensive data management solutions that ensure your clinical trial data meets the highest standards of quality, integrity, and regulatory compliance.

Core Capabilities

CRO Partner and System Selection: Selection of the right CRO partner and system to meet the needs of the project
Database Design & Build: Custom EDC database development tailored to protocol requirements
Data Quality Management: Comprehensive edit checks and validation rules
Query Management: Efficient query generation, tracking, and resolution
Medical Coding: MedDRA and WHODrug coding oversight and quality control
Database Lock: Clean database delivery and audit trail documentation

Deliverables

Data Management Plans
eCRF Specifications and Annotated CRFs
Edit Check Specifications
Data Quality Reports
Vendor management and oversight

Clinical Data Analytics

Turn raw clinical data into strategic insights with advanced analytics and visualization that drive informed decision-making.

Analytics Services

Statistical Programming for Diagnostics: R and Python programming for complex analyses
Interactive Dashboards using Quarto and R Shiny: Real-time trial monitoring and KPI tracking
Operational Optimization Enrollment and patient recruitment forecasting
Risk-Based Monitoring: Central monitoring analytics and signal detection
Data Visualization: Custom reports and infographics for stakeholders

Technology Stack

Programming Languages

R Python SQL

Data Partnerships and Requirements

Leading data requirements and partnerships with CROs, registries, large healthcare systems groups, and external data sources.

Examples of Previous Projects

National Registry Datasets: Defining requirements for and aquiring primary endpoint datasets from national cancer registries
FDA Annual Reports: Aligning deliverables with CRO partners and sponsor/client leadership on delivery of data for regulatory reporting
Trial Data Reporting from EHRs / EDWs: Partnering with US healthcare systems for scalable, privacy-protected data access for trial reporting and analysis
Large Scale Data Transfers: Acquisition, QC and reporting for large imaging datasets (DICOMS) from external vendors

Expertience with Varies Organization Types

Academic Organizations and Healthcare Systems

Mayo Clinic Cleveland Clinic HCA Healthcare Sutter Health University College London University of Oxford

National Partners

National Health Services (NHS) National Cancer Registries (UK)

Systems Configuration

Expert implementation and optimization of clinical trial management systems to maximize efficiency and streamline workflows.

Platform Expertise

EDC Systems: Development, Testing and Governance
IRT/IWRS: Randomization and drug supply management systems
eTMF: Trial Master File management for DM and regulatory submission support
Cloud Platforms: Data storage, exchanges and compute using AWS (S3, EC2) and GCP

Implementation Services

System requirements gathering and design
Database build and configuration
User Acceptance Testing (UAT) support
System validation and documentation
Training materials and user training
Post-go-live support and optimization

Compliance and Inspection Readiness

Preparing data and operational teams running clinical studies on BIMO, inspection readiness, and assess gaps in compliance. Our team has past experience conducting gap assessments, participating in inspection readiness and audits from entities like the NHS.

Review of systems and processes to provide best practices
Advise on alignment with ICH, GCP, 21 CFR Part 11, EMA and GDPR guidelines
Inspection readiness coaching
Compliance remediation support
Generating practical, and actionable reports for compliance excellence
Post-go-live support and optimization

Our Services