Quanticate has been working successfully with a large Scandinavian pharmaceutical company over the past 12 months in the area of clinical data management (CDM); focused on the delivery of clean quality clinical trial databases in a system mandated by the Sponsor with additional statistical programming support in the creation of SDTM templates.
The Sponsor’s requirements had not been fully understood by the Interactive Voice/Web Response System (IXRS) and Electronic Data Capture (EDC) system providers, leading to frustration and delay. Quanticate took a lead in working with the technology vendor to set expectations and to manage future requirements in two clinical trials. The on-going problems were resolved through technology enhancements developed by our team of experts. The establishment of a governance structure between Quanticate, the Sponsor and the technology vendors, enabled us to proactively anticipate and manage challenges associated with any future protocol amendments. Feedback from the Sponsor was very positive due to our pro-activeness and investment in the partnership.
The traditional approach to data cleaning is that CDM do not review the data until after it has been source data verified by monitors on site. Quanticate is taking the approach to clean data once it is entered by the site. This supports risk-based monitoring, enabling the monitors to review any CDM issues prior to their next monitoring visit. This results in more efficient data monitoring and streamlining of data cleaning. Due to this data cleaning approach, the Quanticate Biostatisticians can confidently transfer semi-clean monthly SDTM datasets. In parallel, CDM transparently ensure that the Sponsor clinical operations group are fully informed of data cleaning status. This is done by weekly and ad hoc reporting to ensure clinical operations resource is focused where required.
The concept of library of templates in our EDC to SDTM mapping process has been previously mentioned but it is just the beginning of a larger project. Quanticate is developing tools which inject annotations from aCRF directly into the mapping specification which together with other enhancements makes delivery of define.xml 2.0 very easy. Therefore, all of Quanticate’s processes are designed in a way which optimizes production of define.xml 2.0.
Other projects include our new EDC user acceptance tool which will be supporting both CDM & Programming departments. CDM will improve the edit check process while Programming will start receiving data extracts quicker and this extract will contain all common data scenarios. In addition, this is the area where we anticipate benefits of applying Machine Learning techniques.