OmniComm’s technology has always embraced the use of industry standards to provide economies that enable data portability, increased quality, and reduced cycle times. Customers have the option to leverage those standards they see fit best into their unique process and OmniComm’s staff will assist in the implementation of those standards.
Some of the areas that we support include:
OmniComm was the first company to provide a library of CDASH (Clinical Data Acquisition Standards Harmonization) eCRFs to the life sciences industry, and we have maintained and grown that library as the standard has evolved. We have found that the use of CDASH has derived multiple benefits, including streamlined eCRF design, expedited study development, standardized training processes, and a simplified path towards SDTM submission.
Our OmniConnect™ Web Service API is designed around the CDISC ODM (Operational Data Model) standard, allowing for read and write access to your data using an approach that conforms to ODM.
Our custom export utility provides a SDTM (Submission Data Tabulation Model) mapping utility that allows you to map data from your electronic Case Report Forms, direct into SDTM output, and ready for regulatory analysis and submission – all with a complete audit trail of any necessary data derivations or transformations.
OmniComm uses the International Council of Harmonization (ICH) standard to pass data through our SafetyLink™ tool from an EDC application to a robust drug safety and pharmacovigilance application.
OmniComm maintains the most recent versions of the WHODrug (World Health Organization Drug) dictionary within our state-of-the-art AutoEncoder. Customers can map to the most appropriate drug definition and nomenclature by performing a streamlined search of the most recent WHODrug dictionary version.
OmniComm maintains the most recent versions of the MedDRA (Medical Dictionary of Regulatory Activity) dictionary within our state-of-the art AutoEncoder. Customers can either automatically or manually code data against the dictionary that is the globally standard for normalizing indications and adverse event data.
OmniComm has adopted the RFD (Request Form for Data) standard for integration between third-party Electronic Health Record (EHR) applications and our EDC applications. The advantage of an integrated EDC/EHR solution includes reduced redundancy, expedited data entry and access, and a single source of clinical trials data enabling reduced source data verification. OmniComm has demonstrated this capability with several EHR applications, and we are seeking partners (both sponsors and EHR vendors) to utilize this technology on a live trial.