Clinical Research Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research. Clinical Data Management includes paper and electronic case report form (CRF) design, clinical trials database design and programming, data standards, system implementation, data acquisition, data integration into the clinical trials database, data review, validation, coding and database finalization. Data management tasks are often technical and specialized.
The goal of Clinical Data Management is to ensure that the data supports conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.
Our primary focus is patient and we ensure our technologies, processes and work ethics brings solutions that are patient centric We perform End-to-End Clinical Data Management with enhanced integration of data science and solutions delivering quality work to our customers and sponsors.
We have expertise in coding clinical data collected in various medical and medication forms such as Adverse Events, Adverse Drug Reactions, Serious Adverse Events, Medical history, physical abnormalities, surgical procedures, Device related events, prior and present concomitant medication, antiretroviral medications, antibiotics and concomitant procedures.
Our processes and conventions ensure we deliver data that has highest standard of quality, data integrity and meets global standards. This ensure that the coded data can be shared with common understanding across multiple information systems. Also, our coded data process enables consistent and accurate data analysis when collected into a data repository such as Regulatory database.
One of the challenging approaches for preparing the CDISC-compliant data is the need to convert the legacy data to create the CDISC-compliant data. Cytespace with its rich experience aims to provide guidance for regulatory submission and help execute data conversions.