Data Management

We offer two data collection options: electronic data capture (EDC) for electronic data entry at sites or paper case report forms (CRFs) for paper data entry collected from sites and entered in-house. The computer system used for data collection, processing, transfer and storage is 21 CFR Part 11 compliant and has been validated by multiple FDA audits. Our 100% web-based system offers real-time data management capabilities to sites and sponsors.

To meet timelines, database setup and database lock are performed at industry-leading speed, and we provide tables and listings of accumulating data during the treatment phase of a clinical trial, allowing sponsors to conduct ongoing data reviews.

Our Integrated Safety Database (ISDb) takes multiple databases from multiple clinical trials, for a single product, and makes them uniform so that safety data from all the databases can be analyzed through a single database. The ISDb is a powerful tool to analyze the safety data of multiple studies, and to rapidly generate safety data for annual IND reports.

Data protection and integrity is maintained through:

• An access-controlled data center
• Regular data backups with off-site storage
• Backup power
• Disaster recovery procedures
• 24/7 monitoring by IT staff

​Services include:

• Data management plan
  • Trial specific
  • Version controlled
  • Data processing
  • Nomenclature conventions
  • Medical term coding specifications
  • SAE and AE reconciliation procedures
  • Final and interim data lock procedures
  • Data entry instructions
• Case report form design
• Custom-designed databases for each clinical trial
• Database customized programming (EDC or paper-CRF)
• Data collection, data entry and validation
• Analysis dataset creation and transfer
• Multiple-study integrated safety database
• eCRF design
• Customized status reports and trackers
• Data cleaning
• ePRO

Our highly experienced clinical safety professionals provide clinical and medical expertise to evaluate the safety and conduct of Phase I-IV clinical trials.

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We identify the best method of analysis for each individual protocol, determining efficient and accurate pathways to product approval.

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