OCS Life Science Solutions

Welcome to OCS Life Science Solutions

Even though the Life Sciences 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 our all our expertise of our Biometric Support Services and create OCS Life Science Solutions: a specialist CRO which focuses on bringing high-value expertise and services to our Life Sciences clients.

As a CRO dedicated to data analytics, we provide end-to-end solutions from data management, data analysis and reporting, to medical writing.

CRO

Data Management Statistical Programming & Biostatistics CDISC Standardisation &
Standards Development

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.

SAS

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.

Training

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.

Data Quality checks

To get data of high quality, checks are built as programmed system checks directly upon entering data, and data managers and medical experts perform manual checks. Monitors check on site data with the source.

R

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.

Define-XML

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.

eCRF design

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.

Tables, Listings & Figures (TLF)

Abbreviated as TLF these are a 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.

ADaM

OCS Life Science Solutions has a solid experience in creating datasets  supporting efficient generation and replication of statistical analysis, which are conform the CDISC ADaM (Analysis Data Model) standard.

Descriptive statistics

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 extensive analysis of the clinical data.

SDTM

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.

Validation

 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.

SEND

OCS Life Science Solutions has a solid experience in the organisation and structure of non-clinical tabulation datasets which are conform SEND (Standard for Exchange of Nonclinical Data), for example for carcinogenicity studies.

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 the available trial data.

Standard macros

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.

Meta-analysis

 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.

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.

Statistical modelling

 Based on the assumptions of a clinical trial, statistical modelling is used to approximate reality and make predictions from the approximations. Our statisticians have expertise in a wide variety of commonly used statistical models.

Standard software

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 e.g. SDTM.

 


Interested to find out what OCS Life Science Solutions can do for you? Please contact info.nl@ocs-consulting.com.