Data Management
Veristat provides data management services utilizing industry leading software packages designed for both paper-based and electronic data capture (EDC) clinical trials. We work with our clients to select the appropriate technology for successful completion of any size or phase trial.
Data Management services include:
- Case Report Form (CRF) design
- Database design, creation, and maintenance
- Annotated CRFs to both the database design and CDISC standards
- Data entry
- Data validation programming and testing
- Data cleaning and query management
- Medical coding using WHO Drug and MedDRA dictionaries
- Serious adverse event reconciliation
- Laboratory data reconciliation
- Database lock
- Database transfer
- Creation and maintenance of safety database for a single study or a global repository
- Integration and verification of external electronic data
- EDC end user training
Clean and Accurate Data Collection
Veristat provides clean and accurate data to ensure our clients have a quality end product. Prior to database lock for a paper-based study, Veristat performs a database quality control producing a report of findings for Sponsor review and approval to ensure the acceptable error rate was achieved before locking the database. This process consists of reviewing 100% of the Critical Items for all patients in the study as well as randomly selecting 10% of patients for a non-critical item review. Veristat’s acceptable overall database error rate is less than 0.05%.
Data Security
Both the Clintrial™ and InForm™ systems contain role-based security that is configurable; therefore allowing access to specific individuals and only to those functions and pieces of data necessary to their role and responsibilities. Veristat has full back-up and recovery procedures as well as full disaster recovery systems in place. Disaster recovery servers are in a fully secure and compliant off-site data center allowing, in the case of a disaster, minimal downtime with no loss of data.
Flexible Data Solutions
Veristat offers paper-based as well as Electronic Data Capture solutions to ensure we can meet the needs of any clinical trial. Veristat has also developed proprietary tools and standards to work with these products to further enhance the process and provide our clients with a streamlined and efficient approach to data management that results in a quality end product.
Paper Based Data Management
For paper-based trials, Veristat uses Clintrial™, version 4.6, for our clinical data management system. Clintrial™ is a production-proven clinical data management system that is scalable, having been deployed to manage thousands of clinical trials accommodating clinical study designs of various sizes and levels of intricacy
Electronic Data Capture: Cost-effective e-solutions for your Clinical Research Program
Veristat has a strategic partnership with Phase Forward utilizing their industry’s leading EDC system, InForm™. Veristat can help your clinical research program run faster and more efficiently.
EDC saves valuable time by streamlining the data validation process and automating query resolution, resulting in a decrease in time from first patient in to database lock. Using EDC technology, Veristat helps your site staff and clinical monitors capture data with greater accuracy. As a Sponsor, you have access to real-time data and a robust reporting library with over 32 standard reports to manage the trial more effectively. Veristat’s ability to build the EDC database allows flexibility to take a custom approach that precisely meets your needs and your budget. To support your clinical trial team, Veristat offers a 24/7 global helpdesk and comprehensive system training for the end user.
For more information on our Technology Partners, click here.
IVRS
Veristat offers IVRS solutions through preferred partnerships. Our preferred systems provide phone and web access. In addition, Veristat has experience integrating these IVRS solutions into Veristat’s data management systems for seamless trial design.