At Factory’s Data Management department we cover every aspect of Data Management and Statistics, e.g. CRF design, data entry, database design, data validation, statistics and consultation.
Our highly skilled personnel
adheres to the European Clinical Trial Directive and GCP which is officially applicable to medical device studies,
uses the unofficial Good Clinical Data Management Guideline as guide (www.scdm.org), and
works from the philosophy that data quality comes through speed and transparency.
These 3 requirements are reflected by our Data Management System, DataFax, and our Statistical software, SAS. It is our experience that Investigators strongly adhere to a paper based CRF and that electronic CRF solutions are inadequate and disturbing their busy schedule and do not want to do the time-consuming aspect of the insertion of the clinical data. DataFax combines the advantage of a paper based CRF while benefiting from electronic data transfer by facsimile.
CRF design
With our inside knowledge of the surgeon’s routine we can design CRFs efficiently to get reliable data for primary and secondary endpoints. The study database is built based on a SAS-annotated CRF.
Data entry
Next to standard double data entry, the client can also choose between computerized data entry which may be excellent choice for Post-marketing trials, and computerized data entry with verification, which is much more time and resource efficient.
Database design, data validation, database lock
Our databases are designed using the CDISC SDTM model as a guide. The study database setup is therefore guided by the SAS-annotated CRF. With the database in place a Data Validation Plan is made that contains all checks for your study, both electronic as well as manual. Electronic checks are programmed to either pop-up during data entry or data validation, or to be run in a separate batch. Subsequently, queries are send and received by fax to ensure a speedily query turnover, which results in a higher quality because the information is still fresh in the Investigator’s memory.
When the cleaning process is finished, a quality control check is performed on the database after which the database is locked and ready for statistical analysis.
Reporting
During the trial we can keep you up to date with your study’s progression by providing you with automated reports that are send by our Data Management System on a weekly but even hourly basis. In addition, more extensive study overviews can be made with SAS and can be customized to your wishes.
Statistics
Prior, during and after a study many questions play a role. Before your study commences, we may consult you on the required population size to meet your targets, and review or write the section on the statistical considerations in your study protocol. During your study, we provide interim analyses. After your study, we may assist you in analyzing the study data, assist in “translating” the statistical report and help you in writing the final report.
Data Management Consultation
Next to data management services our Data Management department offer consultation on the data management process such as protocol review, and setup of SOPs for your starting data management department.
Study Portal Development
As a co-design partner we support the development of a web-based Clinical Trial Investigator Portal. See Study-Portal.com for the latest developments.
