Clinical trials information systems

Services for Clinical Trials

• Study design, sample size estimations and power calculations
• Database design, data entry and validation
• Data warehousing for clinical trials
• Statistical analysis and reporting
• Medical writing

Related services

• Toxicity and safety models
• Regulatory guidance and consulting
• Biomarker discovery and validation
• Pre-clinical pharmacokinetics
• In vivo disease models

Technology expertise

We provide our customers with technology expertise in pharmaceutical R&D computer systems for data management, data warehousing, adverse event management, document management and electronic submissions. For these we also provide computer system validation expertise in accordance with 21 CFR Part 11.

Electronic data capture & remote data entry

We provide our customers with electronic data capture system/services (through our partners) to accelerate data collection and to ensure high quality data.

Pharmacovigilance

We provide our customers with adverse event management system/services (through our partners) to help you manage and report these events.

Document management

We provide our customers with document management system/services (through our partners) to improve collaboration in your project team, including internal and external team members.

All our services are tailored for customer needs. For more information, contact us from this link.