A full-service model centralizes all trial operations under one roof, providing a “single point of accountability” for the sponsor.
Protocol Development: Drafting the scientific blueprint for the study.
Feasibility Assessments: Analyzing global sites and patient populations to ensure the study can realistically meet its goals.
Regulatory Consulting: Navigating local and international laws (FDA, EMA, PMDA).
2. Study Start-Up & Site Management
Site Selection: Identifying and qualifying high-performing investigative sites.
Ethics & Regulatory Submissions: Managing IRB/IEC approvals and country-specific filings.
Patient Recruitment: Designing digital and community-based strategies to enroll diverse patient populations.
3. Clinical Operations & Monitoring
On-Site & Remote Monitoring: Ensuring trial sites adhere to the protocol and Good Clinical Practice (GCP).
Risk-Based Monitoring (RBM): Using data analytics to proactively identify and mitigate trial risks.
Trial Logistics: Managing the supply chain for investigational products and medical equipment.
- 4. Data Management & Biostatistics
Electronic Data Capture (EDC): Building secure digital databases for real-time data entry.
Standardization: Converting raw data into CDISC (SDTM/ADaM) formats for regulatory review.
Statistical Analysis: Executing the Statistical Analysis Plan (SAP) to prove safety and efficacy.
5. Safety & Pharmacovigilance
Safety Monitoring: Tracking and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs).
Global Safety Databases: Maintaining compliant records of the drug’s safety profile throughout the trial.
