Product Overview
TracIt2k is a software system designed for accumulation and transmission of clinical trial data. From any location in the world, TracIt2k allows trial sites to enter, store, retrieve and transmit clinical trial information at any time. Information entered at the trial site is in your database within seconds. No more duplicate data entry, trying to read sloppy handwriting, numerous calls to the trial site searching for missing information, waiting for forms in the mail and no more paper.
The development of the TracIt2k software system was done in full compliance with the Food and Drug Administrations (FDA) Guidance document for "Computerized Systems Used in Clinical Trials". TracIt2k is in compliance with the FDA's 21 CFR Part 11 guidelines that provide criteria for acceptance of electronic records and signatures. TracIt2k assures that there is proper verification of completed records.
The following is a brief summary of the system's operation:
Case report forms (e-CRF's) are created by Acumen, the sponsor or CRO using TracIt2k's Easy Dynamic Design Editor (TEDDE).
e-CRF's are placed on host server at our Tier One Data Hosting Center.
Personnel at the investigative site log onto the host server using an internet browser, enter trial data into the TracIt2k system and save the record. Data entry is made easy with field choices, range validations, auto entries and clinical logic incorporated into the fully customized TracIt2k system.
From any location in the world, monitors can log onto the host server, electronically review and query any data point at sites for which they are responsible. They may also create electronic generic queries for non-data point information requests.
After the data are checked and found to be complete and accurate, the Principle Investigator electronically signs the forms. These data are mapped and uploaded into a locked database.
Custom reports can be generated and displayed for all or individual users.