Clinical Trials Data Management
Clinical Data Management System
Our clinical data management system is a powerful tool for the effective and flexible management of your project. The system readily accepts project specific adjustments and meets FDA’s electronic records regulation (21 CFR Part 11). We provide online access to the data in various formats, enabling you to view the data at your convenience. Data can be exported as SAS datasets or into a format of your design and choice.
Our CRF designs assure that the data recorded on them support your protocol objectives. We coordinate the printing and shipping of CRFs to the investigator sites to expedite study start up and enrollment. In addition, we produce instructional documents for investigators and monitors to promote accurate data recording and query resolution.
Database Design and Development
The clinical database is developed from your protocol and CRFs for precise data storage and reporting. We document the database design and fully validate the database to guarantee its functionality and stability. Our data conversion programs are designed to your specifications for the final database transfer, and we provide converted datasets for interim review.
Dual Data Entry and Reconciliation
Independent dual data entry and reconciliation is one of the most reliable methods of data capture and minimizes database errors. Two people enter the data independently. Then a third person runs a program that compares the two datasets. All discrepancies reported by the compare program are corrected based on the CRF data. We continue the comparison process until all data errors are resolved.
We employ a variety of tools to guarantee the quality of your data including verification checks, medical and data reviews, and quality control audits. Based upon your protocol and specific requirements we develop and validate verification checks. Our verification checks include logic, range, across form, and consistency checks of the clinical data. We also conduct medical and data reviews of the CRFs based on internal conventions as well as conventions that address your specific protocol. Periodically, we conduct quality control audits to assure database integrity and adherence to medical and data review conventions.
BSI uses a flexible data clarification system to report data errors that are not resolvable through documented conventions. Our system can be tailored to provide you with reliable Data Clarification Form (DCF) generation, resolution, and tracking. We expedite DCF response at the investigator site and reduce the need to requery by using query templates to standardize query wording.
BSI has developed an automated dictionary coding platform that is adaptable to a wide variety of dictionaries. Regardless of the type of dictionary your project requires, we have the ability to customize our autoencoder to facilitate the most accurate and reproducible coding of your clinical terms. BSI has many years of experience coding medical history, therapy, procedure, and adverse event terms.
We routinely import a variety of data types from third party vendors including laboratory data, data from biological assays, and data collected by remote clinical monitoring devices. The programs we design to import and format data from third party vendors are validated to ensure the integrity of the data. Use of verification checks assures the accuracy and completeness of the external data received from each vendor.
BSI also uses remote data entry for the capture of clinical trial data. Electronic data capture continues to be a focus area in the clinical trials industry and we have actively explored this field for several years. We conduct remote data entry using vendor supplied software platforms or through the development of remote data entry programs designed specifically for you.
Biostatistics and SAS Programming
Our biostatisticians have the expertise to support your needs in clinical study protocol development, statistical planning and data review, statistical analysis, and statistical report preparation. Our statistical programmers are experts at SAS programming, including production report programming and program validation.
For more information on BSI’s Biostatistics services, contact Paul Felton
(501) 758-6290 ext. 126 or
