Data Management

DatManPic1.jpg

HistoGeneX understands the transition from research to clinical trials. We have provided and supported data requirements for research projects through Phase III registration and companion diagnostic applications. In each, we have established processes and expertise as part of our commitment to provide data integrity and to deliver quality results.

Our 21CFR Part 11 compliant HistoGeneX laboratory information system (H-LIMS) is powerful, yet flexible. Our data and project managers will integrate your requirements (specified prior to project commencement) into a customized database that is secure, intuitive, easy-to-use and meets the specific needs of your study. Our databases offer these routine features and are pre-tested before activation:

  • FDA 21CFR part 11 compliance
  • Case report form tracking system
  • Full audit trail
  • Automatic and manual edit query system
  • Version control tracking and documentation
  • Database validation and documentation
  • Customized security-defined access
 

 

Convenient Electronic Lab Request Forms (eLRF)

Clinical sites can send sample collection and processing data for individual samples with our convenient and fully customizable eLRFs. HistoGenex eLRFs require standard PDF reader software and an e-mail account.

Secure Electronic Sample Pre-Registration

HistoGenex offers electronic pre-registration of clinical trial samples before actual sample shipment to expedite sample reception and reduce human errors.

Flexible Reporting

HistoGeneX provides results to clinical sites per your specification, usually via PDF or hard copy format, including facsimile. We predefine report formats with your sponsors.

HistoGeneX data management team also provides batch report files configured according to the file format specifications established with your data management team. HistoGeneX can deliver the data files through secure FTP connection or your custom data portal.