Auxiliis uses TrialMaster™, an MSSQL-based clinical data management system provided by OmniComm.
There is a backbone database system in Budapest with our own data management and programming staff supporting all data management needs of a clinical trial. In order assure reliable operations at all times, Auxiliis has also access to an independent server farm, which contains the internet backbone of Hungary. This set-up ensures adequate internet bandwith even for large size trials.
TrialMaster™ is validated electronic data management system compliant with all FDA and EMA regulations. This system has in-built Academy training options for all user levels engaged in the system. Investigators need to pass a basic training module before they will get automatic access to enter trial data. Full edit check and very smooth data management and cleaning are features of this eDC system. Automatic flagging resulting in fully automated e-mail sending to relevant staff of sponsor or CRO is easily set up. In addition, TrialMaster™ has a risk based monitoring module and a CDISC/SDTM (define xml) mapping facility which has been internally validated by Omnicom. If needed, TrialMaster™ also supports paper based data collection. Auxiliis can integrate data from third sources (e.g. central laboratory, ePRO, etc) into the clinical database.
Auxiliis has ample experience in Phase I, II and III with the eDC system of TrialMaster™. Recently, Auxiliis successfully launched a phase III oncology trial in more than 100 sites in Europe, USA, Asia, Australia and New Zealand.
Auxiliis is also happy to work with eDC platforms other than TrialMaster™ if requested by the client.
Guided by the final DCP the data manager will conduct computerised and visual checks on the data. Inconsistencies will either be solved or queries will be raised and sent to the monitors of the study. Coding of the adverse events and medications will be done by Auxiliis. Before database lock a reconciliation of the SAE line listings of the Safety database with the SAE forms in the clinical database will be conducted. Any inconsistencies will be resolved.
Data Analysis and Reporting
Data analysis is done based upon a statistical analysis plan (SAP), including mock tables, listings and figures, created by Auxiliis. After mutual agreement with the customer this SAP becomes the guideline for analysis. A draft version of the tables, listings and figures is sent to Sponsor for review. Comments are implemented in the final version which will be accompanied by the statistical text of the integrated Report (according to the ICH – E3 guideline). Before un-blinding the data, if applicable, a blinded data –review meeting is planned. The major goal is to determine the different analysis population (FAS, SAF, and PPS) and to identify protocol violators.