Omnisol's ontology-centered data management platform is exquisitely suited for handling clinical trial data. Engineering an ontology that precisely captures trial specific concepts and relations, even very complex ones, is fast and easy. With the trial’s ontology in-place, the platform automatically provides means to enter data (eCRF), perform powerful searches, generate reports and infographics and much more.

 

Omnisol’s clinical data management solutions follow ICH and FDA guidelines to ensure the safety, security, validation and integrity of clinical data. A powerful audit-trail module allows the data manager and auditor to track the complete change history of each field in each form of the eCRF.   

 

Omnisol's Platform provides a REST-API for flexible querying of the data stored within it. Using the REST-API, external decision support tools can extract patient information as well as molecular data information. The REST-API can also be used for inserting data into the system, so the external decision support tools can store their recommendations and link them to the relevant entities.

 

One of the unique features of the platform is its great flexibility; you could make changes to the ontology even after you have data in the system and the existing data will be transformed to fit the new ontology. This is extremely useful for the eCRF planning phase, where by the team can prototype and experiment with the fully functional system right from the start.

 

Omnisol’s expertise in data-mining and knowledge-extraction comes into play when clinical data needs to conform to standard dictionaries and taxonomies (ICD-10, MedDRA, WHO-DDE, etc.) in order to ensure data consistency and standardization in the eCRF.

Omnisol works closely with the trial’s data manager to build a specifically tailored, state-of-the-art solution at unprecedented speed and at an affordable cost. Omnisol’s team is continuously available throughout the trial for special requests, training and technical support.

​