Data Management & Biostatistics
Clinmark designs database systems tailored to client’s specific needs in order to ensure effective data entry. We support our customers in designing a study plan and sample size, creating a statistical design, selecting methods of analysis and carrying out partial and final statistical data analysis along with a report. Clinmark’s Team screens data for errors and deficiencies. After that queries are designed. Clinmark has extensive knowledge of electronic data entry systems (EDC) and ensures the integrity and validity of clinical trial data.
Clinmark’s biostaticians provide customers with support in all phases of drug development. Clinmark’s team evaluates data in order to verify that all procedures have been performed according to relevant biostatistical standards. We guarantee exact planning, collection and evaluation of the data.
Data Management
The primary role of clinical data management is to produce high-quality data from data entry through analysis to quality data reports. Study data must be collected and organized according to regulatory requirements, such as CFR21 Part 11 and ICH GCP.
To meet the highest expectations of our Clients Clinmark is using CRSCube solutions. This comprehensive suite of solutions guarantees efficient management of study data. CubeCDMS® is used for data entry and data management and is fully integrated with other cubeSOLUTIONS such as cubeSAFETY®, cubeCTMS® and many more.
CubeCDMS® has secure data backup preventing the risk of corruption or loss of data. It guarantees real-time verification of subject enrollment, query management, and adverse events through the dashboard. It has integrated medical dictionaries: MedDRA, ATC Index, WHODD, CTCAE, WHOART, IDF and others, allowing fast and accurate medical coding. It has also convenient import and export functionality allowing validation and upload of external data such as central lab data.
CubeCDMS® is intuitive, user-friendly and efficient. Therefore, we recommend it to our Clients.