OCS Consulting - Netherlands and Switzerland
OCS Consulting - 30 Years of making IT Happen
OCS Consulting - Netherlands and Switzerland

Profile of Assignments

Life Sciences

CRO Solutions

Scientific CRO

OCS Consulting won a significant project to report on a Clinical Trial. The project consists of the reporting of a Phase II-A clinical trial on behalf of leading company in the development of Alzheimer’s treatments.

Drug Outcomes Research Organisation

This internationally recognised organisation, is dedicated to the improvement of the use, quality and cost-effectiveness of pharmaceuticals through the collection, maintenance and performance research on patient-centric data to derive real-life insights for tailoring of medicines. Our client has undertaken our services to assess the current metadata security model comparing this with best practices and share our findings and recommendations.

Global Pharmaceutical Organisation

OCS Consulting was approached to assist with a large migration project. This pro-ject encompassed the migration of the SAS environment from SAS version 9.1.3 to SAS version 9.3. During this project we also provided support for SAS program code migration and the clients bespoke Information Delivery Portal. Part of this project included the introduction of a second production server utilising load-balancing and failover functionality. This is the first implementation of this con-cept in the Netherlands!

Leading CRO

With offices located across the globe OCS Consulting was approached to pro-vide CDISC training courses for two of the client’s European offices. OCS provided two training courses; the first entitled “CDISC Overview and SDTM Implementation”, which includes a general overview of CDISC and covers in-depth SDTM. The second training course entitled “Define-XML v2.0 for SDTM”, includes an overview of XML and Define-XML, and will drill-down the sections within Define-XML, followed by the creation and validation of Define-XML. The course ends with a summary of tips/tricks and key messages. These courses continue to be extremely popular.

Global Early Stage CRO

Following the implementation of Version 5 of the Flexible Reporting System and the Dosing Control System, OCS Consulting has won the European Support Agreement from this Global CRO. The agreement covers both applications above, and Enterprise Guide Add-ins we have built for the Toxicology department. Such add-ins, previously developed for the analysis of lung function and telemetry data, comprises of a user interface built in .NET with a logical and statistical back-end built in SAS.

In addition to the Support Agreement, our client received a request from the FDA to include additional statistical analysis in their study report. OCS was asked to review this request from the FDA and to perform the statistical analysis using SAS. As patients participate in this study for only 2 weeks, OCS had a strict deadline which was successfully met.

Statistical Programming

Worldwide R&D Organisation

This worldwide R&D organisation continues its strategic collaboration with OCS Consulting for data analysis and statistical services. By signing a preferred partnership with OCS’ specialist Life Sciences business unit, the company can now rely on OCS for flexible resourcing for projects, covering peaks in workload and temporary need for specific skills within clinical data management, clinical programming and statistics teams.

Thanks to this collaboration the client has a ready supply of people with the right experience in terms of clinical data and biomedical research. This enables them to deliver responses and results fast, utilising the best possible team to provide scientific underpinning for products and innovations. This partnership started in 2010 and from 2013 it has been changed into a preferred partnership which enables OCS to provide teams comprising of Data Manager, Statisticians and Statistical Programmers all of whom are experienced with delivering SAS software based solutions.

Global Manufacturer of Medical Devices

OCS Consulting has the unique position of being the only supplier of statistical programming services to this global client. Our client has statisticians who have responsibilities for their respective business units and as the demand for statistical programming within these business units is growing, OCS has been asked to provide additional capacity.

Major pharmaceutical company

OCS Consulting was asked to provide a Scientific Programmer and Validator for two clinical phase III trials. One of our leading SAS Analyst / Scientific Programmers with over 8 years’ service at OCS undertook:

Global Early Stage CRO

  • Critical evaluation of the specifications and construction of the reporting data bases in each of these trials.
  • Production and/or validation of SAS reporting programs; Tables, Listings, Figures (TLFs) for clinical trial Early Results Memos (ERMs).
  • Contributed to the construction and validation of a Global Data Base (GDB); harmonisation of Efficacy and Safety data across many clinical trials.
  • Validation and co-production of ‘Subject Narratives’ for the clinical Safety evaluation in the pivotal phase III trial as well as across all trials in the GDB for this new medical drug.
  • Production and validation of TLFs for the US Food and Drug Administration (FDA) New Drug Application (NDA) submission report.
  • Technology: SAS 9.1.3 & 9.2 on Win-dows XP 32-bit, Unix (AIX, HP-UX), SAS Base / Stat / Graphs

CDISC

International Manufacturer of Vaccines

OCS Consulting has been providing SAS expertise to our client for over 10 years. Our client called upon OCS to redesign the entire data capture and reporting process to a ‘CDISC-environment’ (from data capture, to CDASH, to SDTM) and to undertake the development of a process and standard SAS program to convert legacy data to SDTM compliant data in a controlled environment.

Worldwide R&D Organisation 

As an established partner OCS Consulting were requested to develop a CDISC based data warehouse. One of OCS’ Senior Consultants undertook this project which included:

  • Mapping data from studies with different structures into SDTM de-fined domains
  • Developing a program that uses map-ping information to automatically create SDTM datasets in a controlled way
  • Using SDTM datasets to create ADaM datasets
  • Perform several analyses on ADaM datasets and create instructive graphs
  • Expertise/technical skills; SAS 9.2, SAS 9.4, SAS Base, SAS Macro, SAS Graph, SAS Enterprise Guide.

Bio-pharmaceutical Organisation

OCS Consulting conducted a gap analysis within the Global Biometrics department of this international organisation. These processes range from the creation of CDISC SDTM data sets from raw input data to the generation of reports from this data, and all processes that are in between as determined by the initial gap analysis report findings.

Global Pharmaceutical Organisation

Due to various acquisitions this leading Global Pharmaceutical organisation needed to undertake the process of ensuring future systems migration and procedures began. OCS Consulting collaborated with a team of Data Managers, Statistical Programmers and Statisticians from the client to show-case their specialism in CDISC standardisation by creating of a Proof of Concept for a new CDISC Migration project. Due to OCS’ experience and domain knowledge we have been successful in partnering the client in this process and delivering a variety of projects, including:

  • A 12 month project to develop and validate several standard software applications using SAS that supports the randomisation of clinical trials, and the reporting thereof
  • the writing of functional specifications, test and installation scripts, and the execution of the validation, in close co-operation with the client.

Global Pharmaceutical Organisation

This client, having seen one of OCS Consulting’s Senior Consultants presenting at the Annual PhUSE Conference, a pa-per entitled “Create your own SDTM Mapping Framework”, contacted OCS for assistance. For their data collection and reporting processes our client are implementing a series of solutions that allows them to have access to SDTM data in the early stages of their clinical trials. The client required OCS’ help in building a component to convert data from their existing system into SDTM data. OCS has designed the architecture and is now developing the solution using SAS soft-ware.