Clinical Data Management
Comprehensive data management services including CRF design, database build, data cleaning, and validation for clinical trials.
Biostatistics Services
Statistical analysis plans, CDISC conversion, TLF programming, and regulatory submission support from expert statisticians.
Pharmacovigilance
Case processing, safety reporting, signal detection, and risk management planning for patient safety and regulatory compliance.
Clinical Operations
Site management, monitoring, project oversight, and quality assurance for efficient clinical trial execution.
Regulatory Affairs
Regulatory strategy, submission preparation, agency interactions, and compliance with FDA, EMA, and other global authorities.
Quality Assurance
Auditing, SOP development, quality management systems, and compliance monitoring for GCP and regulatory requirements.
Medical Writing
Protocol development, clinical study reports, investigator brochures, and regulatory submission documents.
Training & Implementation
Software implementation, user training, SOP development, and process optimization for clinical trial operations.
