In this newsletter:
- OCS Life Sciences at PHUSE EU Connect 2024: Join Us in Strasbourg!
- Our CRO oversight service
- An introduction to PK and PD
OCS Life Sciences at PHUSE EU Connect 2024: Join Us in Strasbourg!
We are pleased to announce our participation in PHUSE EU Connect 2024 in Strasbourg! Jules van der Zalm, Melanie Schopp, Emmy Pahmer, and Yves Poriau look forward to engaging with the data science and statistical programming community.
We will deliver two presentations:
- Implementing CDISC CORE in a Cloud Native, Regulated Environment Supporting Rare Diseases Submissions
- Authors: Emmy Pahmer, Sandeep Juneja (argenx)
- This presentation discusses the implementation of the CDISC Open Rules Engine (CORE) within the SAS Life Science Analytics Framework (LSAF) at argenx, highlighting challenges, CORE functionality for rare disease studies, and future plans.
- Enabling an End-to-End Data Flow of Real-World Data from Source to Regulator
- Authors: Berber Snoeijer (ClinLine), Jules van der Zalm
- This presentation proposes using the OMOP standard to standardize data transformation from FHIR to CDISC SDTM, ensuring traceability and efficient mapping for regulatory submissions.
We would love to connect with you during the event. Whether you’re interested in our presentations, potential collaborations, or just meeting our team. Schedule a meeting.
Let’s make the most of PHUSE EU Connect 2024 together. See you in Strasbourg!
Our CRO oversight services
Pharmaceutical and biotech companies frequently collaborate with CROs to manage biometrics for clinical trials, including the delivery of SDTMs, ADaMs, and TLFs. However, identifying data or reporting issues late in the process can lead to significant delays.
Why CRO oversight matters: While CROs handle many tasks, sponsors remain accountable for final results, making regular reviews and clear communication crucial. The FDA’s 2013 guidance on risk-based monitoring emphasizes the need for sponsors to oversee CRO work, including performance and quality assessments.
At OCS Life Sciences, we offer expert CRO oversight to maintain biometrics excellence and regulatory readiness. Our services include adherence to CDISC standards, statistical code review, and submission readiness.
Read the full article here to learn more about how we can support your clinical data processes.
An introduction to PK and PD
by Mariska Burger and Kees Duineveld
Have you ever wondered why medications come in different forms or why some are taken orally while others are given intravenously? The answers lie in pharmacokinetics (PK) and pharmacodynamics (PD). PK explores what the body does to the medication, including absorption, distribution, metabolism, and excretion. PD, on the other hand, examines what the medication does to the body, such as lowering blood pressure. This article delves into PK, highlighting how patient factors and drug properties influence medication effectiveness and safety. Discover the science behind medication administration and its crucial role in drug development at OCS Life Sciences.
Read the full article to learn more!
For more information or to get in touch with us, contact Erik Hamminga at erik.hamminga@ocs-consulting.com.