OCS Life Sciences
Even though the Life Science industry has been going through a number of changes, we have identified that there is a clear need for flexible, high-quality and cost-effective Life Sciences services and solutions. At OCS Consulting, we have decided to bring together all expertise of our Biometric Support Services and create OCS Life Sciences a specialist CRO which focuses on bringing high-value expertise and services to our Life Sciences clients. As a CRO dedicated to data analysis, we provide end-to-end solutions from data management, data analysis and reporting, to medical writing.
Clinical data management and coordination
- Clinical Data Management is responsible for the complete, accurate and consistent collection of clinical data using electronic Case Report Forms, electronic diaries, mobile applications, paper forms or via direct import in SAS.
Data Quality checks
- To get data of high quality, checks are built as programmed system checks directly upon entering data, and data managers or medical experts perform manual checks. Monitors check on site data with the source.
- Data are collected in a Database Management System that consists of Case Report Forms, edit checks, MedDRA and WHO drug coding modules and a query system. Access is granted after training on a specific role that suits the function.
Statistical Programming and Biostatistics
- As a Gold Partner of SAS Institute we have seen and worked with many of both recent and legacy solutions, including SAS Studio, Enterprise Guide, SAS Drug Development (SDD), Life Sciences Analytical Framework (LSAF) and of course the Enhanced Editor
- R is becoming more popular in industry and has many supporting modules for statistical models and graphics, but regulation in life-science industry demands high levels of software validation in connection with the use of the open source software.
Tables, Listings & Figures (TLF)
- Abbreviated as TLF these are core components to any clinical trial report and submission. Our statistical programmers are experts in the efficient development of TLF that are easy to read and interpret.
- With descriptive statistics we provide simple yet essential summaries of clinical data. Whether in tables or graphs these summaries will form the basis for both the initial description but also the extevise analysis of the clinical data.
- To be sure all deliverables are of good quality we perform validation. The level of validation is dependent on the importance and complexity of the deliverable.
Statistical Analysis Plan
- Abbreviated as SAP, a statistician creates this document together with a clinical researcher and statistical programmer. The SAP is a detailed description of how to analyse clinical trial data, based on the objectives and available trial data.
- Combining results from several separate studies might improve precision, power and settle controversies around conflicting claims, but could however, be misleading when combined trials differ in design, so always consider within-study bias or variation across studies.
- Based on the assumptions of clinical trial, statistical modelling is used to approximate reality and make predictions fro the approximations. Our statisticians have expertise in a wide variety of commonly used statistical models.
CDISC Standardisation and Standards Development
- OCS Life Sciences provides public and private training to enable companies to implement CDISC Standards (SDTM, ADam and Define.xml). Training include exercises to guide attendees in implementing the principles of the CDISC standards.
- One of the competences of OCS Life Sciences 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 Sciences has 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 Sciences 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 Sciences has solid experience in the organisation and structure of non-clinical tabulation datasets where conform to SEND (Standard for Exchange of Nonclinical Data), for example carcinogenicity studies.
- Certified programmers at OCS Life Sciences 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 Sciences provides services according to clients' Standard Operating Procedures and Work Instructions. If required, OCS 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 SDTM.
For more information on OCS Life Sciences please email firstname.lastname@example.org or telephone 020 8731 4338.