Amarex offers 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
- 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
PharmacovigilanceOur highly experienced clinical safety professionals provide clinical and medical expertise to evaluate the safety and conduct of Phase I-IV clinical trials.
BiostatisticsWe identify the best method of analysis for each individual protocol, determining efficient and accurate pathways to product approval.
Book a meeting or send us a message to talk to one of our experts.