TRAINING

Our training services are designed to empower your team with essential skills and knowledge. We provide extensive training in CDISC data standards, SAS programming, and statistics with a focus on PK. Additionally, we offer in-depth training on SAS software, including LSAF, and therapeutic-area-specific CDISC training to ensure your team is proficient and up-to-date with the latest industry practices.

CDISC SDTM

An introduction to CDISC SDTM data standards and related topics, including (but not limited to):

  • CDISC overview including CDASH
  • CRF annotation
  • SDTM fundamentals and domains
  • From source to SDTM: step-by-step

CDISC ADaM

An introduction to CDISC ADaM data standards and related topics:

  • Introduction to ADaM
  • ADaM basics and general conventions
  • Fundamentals and purpose of the main ADaM data structures

Statistics for Programmers

Our Biostatisticians developed a training for SAS programmers to learn:

  • Common basic statistical terms used in clinical trials data analysis- Analysing 2*2 and n*p categories
  • Testing normality of the data
  • How to calculate basic statistics using SAS
  • Introduction to different t-tests
  • Correlation and regression analysis

This training is suitable for any SAS programmer who wants to learn basic statistics and how to use it on a regular basis.

PK and PD Basics

Have you heard the terms pharmacokinetics (PK) and pharmacodynamics (PD) and wonder what that is all about?
In this training we will look at:

  • the definitions of PK and PD
  • the course of action of medication through your body
  • the role of PK in clinical research
  • the basic PK parameters and how to calculate it
  • we will zoom in on bio-equivalence studies and how to analyse it

This training is suitable for anybody who are curious to know the basics of PK and you do not require any prior knowledge of this topic.

Fundamentals of Clinical Trials

An introduction to the fundamentals of clinical trials, including (but not limited to):

  • Drug development
  • Trial design
  • Important documents
  • Data management
  • Statistical programming
  • Statistical analysis
  • Guidelines

CDISC Define-XML + S/ADRG

An introduction to CDISC Define-XML (CRT-DDS) and the Study/Analysis Reviewers Guide, including:

  • Introduction to XML
  • Define-XML for SDTM and ADaM
  • Generating and validating Define-XML
  • Walkthrough for SDRG and ADRG

Validation Essentials

An introduction and hands-on training in the basic concepts of validation, including (but not limited to):

  • Development, Validation, Production
  • Peer review and double programming
  • Title 21 CFR Part 11

We can also develop a bespoke training tailored to your needs.

LSAF Training Offering

Is LSAF new for you and would you like to get familiar with the interface of LSAF and learn how to manage content in the repository and workspace? Or are you a LSAF user, but would you like to get more out of your LSAF system as a programmer by for instance setting up more advanced jobs or as administrator in managing privileges, roles and permissions in a more efficient way, then we can help you! OCS Life Sciences offers off-the shelf training suitable for Data Managers, SAS Programmers and/or Administrators, but also develops bespoke training tailored to your needs.

Programming

An in-depth and hands-on training in SAS programming using SAS Studio including (but not limited to):

  • Reading data from various sources
  • Data mapping and conversion:
    - SDTM and ADaM specific derivations (baseline flag, treatment flags, missing data imputation, double or triplicate        measurements, unit conversion, length limitation)
  • Edit checks and consistency checks
  • Producing output:
    - Tables, Listings, Figures
    - Output formats and templates
    - Basis statistical procedures
  • Advanced programming techniques