Clinical trial support covers all data related activities from design of data collection till reporting.

Study Design Phase

We help to choose the appropriate design, postulate the hypothesis to be tested, select the variables to be observed and define the statistical tools.

CRF / eCRF

We are able to design the CRF from the scratch, or we can implement a web-based eCRF. Annotated CRF is also created for data management purposes.

Data Management

Our data management department is able to manage double data entry from paper sources or to support with entering the clinical trial data in an electronic environment.

Randomisation

In case of randomised trials, we are able to support randomisation - even in real-time - for both paper and electronic data collection systems.

Associated documents

The staff prepares the associated documents, like Data Management Plan (DMP), Data Validation Plan (DVP) and Statistical Analysis Plan (SAS) with the table shells.

Query Management

We also define the rules of queries - keeping the opportunity of ad-hoc querying - and we let out the queries at the appropriate time point of the data cleaning process.

Data Cleaning

Data cleaning is fully done in SAS in case of paper-based data collection and partly done within the eCRF system and with the help of SAS in case of eCRF.

CDISC

During preparation of study SDTM and ADaM databases CDICS guidance is followed including testing of the analysis datasets against on-line checking tools.

Statistical Evaluation

After database closure - or even before depending on the actual contract - the first dry-run is prepared and after finalisation of the Tables Graphs and Listings.

Reporting

Statistical Report is prepared under the guidance of ICH guidelines. We include native English speker medical writers in preparation of Clinical Study Reports (CSRs).

Trial Master File, Archiving

After closure of the Trial Master File (TMF), we provide the clinical study data on electonic media (generally on DVD), with the completed pages in PDF-format.

Quality assurance

Quality assurance is fitted to the actual phase of activities, different approaches are applied in document preparation, data management, evalution or reporting.

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