Full-Service CRO Capabilities From protocol to proof. End-to-end trial execution.

We build protocols designed for execution—not just approval. Our team brings deep sponsor-side experience to anticipate operational challenges before they become costly amendments. With 45% of protocol amendments considered avoidable, we focus on getting it right the first time through rigorous feasibility analysis and operationally-informed design decisions.

• Protocol Development & Optimization
• Scientific & Operational Feasibility
• Country & Site Strategy
• Endpoint Selection & Sample Size Planning
• Competitive Enrollment Landscape Analysis

Navigate global regulatory landscapes with confidence. We manage submissions, maintain compliance, and keep your program aligned with evolving requirements across jurisdictions. Our regulatory strategists have direct experience with FDA, EMA, and health authorities worldwide—ensuring your submissions are complete, compliant, and positioned for approval.

• Regulatory Strategy & Pathway Planning
• IND/CTA/IMPD Submissions
• Health Authority Meeting Preparation
• Safety Reporting & DSUR/PSUR
• Global Regulatory Intelligence

Start-up is where most trials lose momentum—industry average is 8 months from site identification to activation. Our fast-cycle playbook has achieved 200+ site activations in under 4 months. Every document, every submission, every blocker is tracked daily with real-time visibility into activation status and proactive intervention on delays.

• Site Selection & Qualification
• Site Activation & Green Light Tracking
• IRB/EC Submissions & ICF Development
• Essential Document Collection & QC
• Contract & Budget Negotiation

Senior project managers stay attached to your program from kickoff to closeout. No handoffs, no learning curves, no competing priorities—you get direct access to decision-makers who own the outcome. Our 24-48h execution cadence means your study moves daily, with proactive risk identification and rapid escalation paths that keep timelines on track.

• Integrated Timeline & Milestone Management
• Budget Forecasting & Variance Tracking
• Vendor Selection & Oversight
• Risk Identification & Mitigation
• Sponsor Communication & Governance

Strong site relationships drive enrollment performance. With 11-40% of sites enrolling zero patients in typical trials, we focus on predictive site selection, proactive engagement, and early intervention for underperformers. Our site management approach treats investigators as partners—providing the support and resources they need to succeed.

• Site Relationship Management
• Enrollment Strategy & Optimization
• Site Performance Analytics
• Investigator & Coordinator Training
• Patient Recruitment Support

We don't do checkbox monitoring. Our RBQM-first approach uses Key Risk Indicators and centralized signals to drive targeted oversight—catching problems before they become findings. Hybrid monitoring combines the efficiency of remote review with strategic on-site presence, optimizing both quality and cost while maintaining inspection-ready documentation.

• Risk-Based Monitoring Strategy
• Centralized Statistical Monitoring
• Remote & On-Site Monitoring Visits
• KRI Dashboards & Signal Detection
• Issue Tracking & CAPA Management

Clean, high-quality data is the foundation of every successful submission. We design databases for efficiency with built-in edit checks that catch errors at the source. Continuous data review and AI-assisted query management accelerate cleaning cycles, while our lock-ready approach means no surprises at database lock—just clean data ready for analysis.

• EDC Design, Build & Validation
• Data Cleaning & Query Resolution
• Medical Coding (MedDRA, WHODrug)
• SAE Reconciliation
• Database Lock & Data Transfer

From SAP development to final CSR, we deliver the statistical analysis and documentation that supports your regulatory submissions and publication strategy. Our biostatisticians and medical writers work as an integrated team, ensuring that analysis results flow seamlessly into submission-ready documents with consistent messaging and regulatory-compliant formatting.

• Statistical Analysis Plans (SAP)
• TLF Programming & Validation
• Interim & Final Analysis
• Clinical Study Reports (CSR)
• Regulatory Submission Documents

Inspection readiness isn't a phase—it's how we operate from day one. Weekly QC cadence, proactive reconciliation, and real-time TMF health tracking mean you're always ready when regulators call. Our quality-first culture ensures GCP compliance is built into every process, with audit trails and documentation that withstand the most rigorous regulatory scrutiny.

• eTMF Setup & Ongoing QC
• Document Reconciliation & Completeness
• Audit & Inspection Preparation
• CAPA Management & Root Cause Analysis
• GCP Compliance & Training