Data Management, Statistics, EDC

Istvan Janosi

Our aim is to provide full expert statistical support in study design, data management, evaluation and reporting of clinical trials of Phase I-IV, non-interventional and epidemiological studies.

Sound SOPs and guidelines, developed over more than 17 years, control our quality. We are able to work from paper sources of data or through any Data Capture system. We can provide full cost-effective, highly automated data management and statistical services to support your clinical trial or research project at all stages.

During the trial planning stage:

As part of a clinical trial planning and design process we can advise on the essential statistical aspects that form the basis of a sound scientifically valid study:  Sample size calculation and power determination as well as preparation of the Statistical Analysis Plan (SAP). Our advice on the design of the CRF (paper or electronic) can be invaluable to ensure simple entry of only relevant data by investigators in a format suitably compatible with database logic – all important matters to get right before the start of a study.

During the study:

We perform double data entry with the relevant QC-activities in a fully logged and audit- trailed environment allowing full monitoring opportunity of the work-flow for our clients. The data clarification process can be fully supported with an automated query generation, review and resolution system depending on your needs.  Appropriate coding and database transformations and extractions are also part of the service.

Analysis and Reporting stage

Statistical programming, primarily based on SAS – but also R if appropriate – performed according to applicable guidelines is a major strength.  Studies differ so we apply a method most appropriate for the work in question be it a clinical trial, observational study or epidemiological survey.   All activities, procedures and outputs are carefully QC’d. We prepare tables, lists and graphs for all endpoints and write the Statistical Report according to the SAP and ICH guidelines.  We can also prepare presentation materials including automated reports and dynamic web-content.

Analysis and reporting of post-marketing studies allows a range of alternative solutions such as application of less frequently used techniques (e.g. Bayesian statistics, structured models, multi-dimensional methods, etc.); Spatial statistical methods or Data-mining approaches.

We have fully automated reporting systems for our EDC/eCRF systems, which enable availability of up-to-date status reports; automated interim analysis report generation; preparation of final statistical reports within 48 hours after database lock in many cases and generation of multilingual reports.

We want to know that what we deliver will meet your required specifications – so we’ll produce a Data Quality Management Plan (DQMP) to illustrate how we guarantee the tasks entrusted to us.

EDC and WEB-based solutions

Web-based solutions, increasingly employed these days in the Pharma and Biotech industry, provide an even more sophisticated service than “simple” EDC/eCRF or paper systems. Our statisticians developed their first eCRF application back in 2007; this was followed by the first patient registry in 2008.

Today we use two distinct electronic product lines:

A) Electronic Data Capture (EDC) / electronic Case Report Form (eCRF)

  • provides a wide range of data entry support tools
  • support of monitoring activities (query generation and handling)
  • support error reporting, exception handling
  • all operations are well documented
  • includes a `help desk’ support
  • equipped with flexible reporting options
  • provides opportunity of linking it to other supportive data collection tools (e.g. Patient Diary)
  • sophisticated AE/SAE handling.

B) Patient Registry

This solution can be considered as a flexible extension of the previous EDC/eCRF system with important differences:

  • Terms and definitions can be modified throughout the data entry process, and the data can be represented according to different interpretations of a given value (i.e taking into account any changes in guideline classifications).
  • Any snapshot of the database can be reproduced whenever a report (publication) is generated. This requirement requires a highly sophisticated audit trail system taking into consideration the potential changes in terminology.

For more information on EDC & Web-based solutions please click here. http://demoecrf.planimeter.hu/index.php?id=2&L=1

Contact Clinical Accelerator to discuss any statistical or Data Management requirements.