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LSAF October 2020
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In this newsletter:
● Project Case - Mapping Engine Pilot for Novo Nordisk
● Looking back at ADaM webinar 2020
● Influencers and outliers
● Automating Process Flows in SAS LSAF
● Let's talk about defining the assignment ![]() Project Case - Mapping Engine Pilot for Novo Nordisk
Following a presentation by OCS Life Sciences’ consultant Lieke Gijsbers and Jasmine Kestemont at the PHUSE EMEA Bitesize event, in which OCS Life Sciences’ Mapping Engine solution was briefly shown, Novo Nordisk - a global pharmaceutical company - reached out to OCS to inquire about the Mapping Engine.
Mapping Engine is a solution developed by OCS Life Sciences that aids in the creation of SDTM datasets. It translates mapping specifications into SDTM datasets without any further programming, which makes the conversion faster, easier and cheaper. It’s highly customisable and extensible, and has proven its worth in hundreds of clinical trials in major pharmaceutical companies.
For this particular client OCS initiated a pilot project in which their data managers and programmers could get hands-on with Mapping Engine. Read the article to find out how.
Looking back at the PSDM ADaM webinar 2020
In December, PSDM and OCS Life Sciences organised a free-to-attend webinar on the topic of CDISC ADaM and Define-XML. In this introductory session trainer and CDISC specialist Lieke Gijsbers of OCS Life Sciences introduced attendees to the most important aspects of the Analysis Data Model and Define-XML standards, all within a timespan of 60 minutes.
Topics discussed included the main ADaM data structures (Subject-Level Analysis Dataset, Basic Data Structure, Occurrence Data Structure), Define-XML for ADaM and the Analysis Data Reviewer’s Guide.
The audience engagement during the Q&A session can be interpreted as a sign of the relevance of this topic. For those who were not able to attend, as well all of those who like to view the webinar once more, a recording is available on the PSDM website.
PSDM is a Dutch network of statisticians, clinical programmers, and data managers working in and for the life sciences and pharmaceutical industry. It is a non-profit organisation that aims at facilitating professional conduct and development of its members and at acting as a platform for the exchange of expertise by means of meetings, workshops, and webinars.
OCS Life Sciences offers extensive training in CDISC ADaM as well as other topics such as CDISC SDTM (including Define-XML for SDTM), biostatistics, SAS programming and SAS LSAF. Use the button below if you would like to be contacted for more information or a price quote. No strings attached – promise.
Influencers and outliers
In today’s modern age social influencers are getting paid to post something on social media. In 2020 Christiano Ronaldo was the highest paid Instagram influencer getting paid an average of $466,100 to $777,833 per post. Outliers, spreading fake news on social media are not paid (or are they?) and are definitely not welcomed on social media.
In statistical analyses we also have influencers and outliers that can have a significant impact on the fit of a statistical model. When we perform regression analyses, for example, we need to verify that the model is not heavily affected by some individual observations. But are outliers influencers and are influencers outliers? What is the difference and how can we easily identify it?
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Automating Process Flows in SAS LSAF
The SAS® Life Science Analytics Framework (LSAF) renders an integrated system that provides a centralised, standardised repository and SAS programming and execution environment in a single solution. One of the notable features of SAS LSAF is the workflow capability. This functionality allows you to automate processes by using process flows, to allocate tasks and to keep track of the progress of tasks and activities. The usage of process flows reduces the manual involvement and it automates, streamlines and tracks processes which benefit the management of your clinical research processes. A process flow is particularly useful when a process consists of several standardised tasks that need to be executed repetitively within or across studies. ![]()
Let's talk about defining the assignment
At OCS, we offer our professional services in the form of both projects and resourcing assignments. In either, it is incredibly important to align on responsibilities and expectations. In a project that is fairly simple, as this is all recorded in the project proposal that we create before the project is granted. Since we execute projects under our internal management we know what to expect and how to act and operate.
Resourcing assignments are different. In the majority of cases our consultants join an existing team in which they are the newcomer. As such, it is important to know how the team operates and what your role in that team will be. But even in a newly formed team it is pertinent to know a few essential details to the assignment. That is why each of our resourcing assignments starts with the creation of an Assignment Definition Report. ![]() ![]() ![]() |