CDISC Standardisation & Standards Development
As a CRO dedicated to data analytics, we provide end-to-end solutions from data management, data analysis and reporting, to medical writing.
OCS Life Science Solutions provides public and private trainings to enable companies to implement CDISC Standards (SDTM, ADaM and Define.xml). Trainings include exercises to guide attendees in implementing the principles of the CDISC standards.
One of the competences of OCS Life Science is creating Define-XML (Case Report Tabulation Data Definition Specification) to describe the structure and content of tabulation and analysis datasets (i.e. metadata) in an XML format.
OCS Life Science Solutions has a solid experience in creating datasets supporting efficient generation and replication of statistical analysis, which conform to the CDISC ADaM (Analysis Data Model) standard.
OCS Life Science Solutions is highly experienced in creating SDTM (Study Data Tabulation Model) domains, (both operational (CDASH) and legacy data to SDTM), the CDISC standard to organise and format clinical study data.
OCS Life Science Solutions has a solid experience in the organisation and structure of non-clinical tabulation datasets which conform to SEND (Standard for Exchange of Nonclinical Data), for example for carcinogenicity studies.
Certified programmers at OCS Life Science Solutions have a structured way of developing and validating macros that are understandable and easy to use. These validated standard macros improve efficiency for our clients.
SOP’s and WI’s
OCS Life Science Solutions provides services according to clients’ Standard Operating Procedures and Work Instructions. If required, OCS Consulting will develop these quality management documents for companies in the Life Sciences industry.
We are developing applications that are customisable, structured, and validated according to functional and technical design specifications. For example, we have developed a standardised mapping framework for creating, for example SDTM.
For further information on our CDISC Solutions, please get in touch.