SCDM: The Festival of Clinical Data Science

Sitero is excited to be exhibiting at this year’s 25th Annual SCDM Conference. Known as the “Festival of Clinical Data Science,” SCDM is at the forefront of clinical data excellence with a focus on inspiring leaders and advancing attendees’ expertise.

Stop by our booth #201 to learn more about how Sitero is delivering industry proven, end-to-end eClinical solutions including: EDC, eConsent, RTSM, ePRO, CTMS, Data management, Biostatistics, and more. We hope to connect with you there!

Location: Hilton San Diego Bayfront, San Diego, CA
Dates: October 8-11, 2023

Session Presentation

Sitero’s Dr. Joby John will be chairing a session where Sitero’s Kristin Marsh and Randall Paulk from Johnson & Johnson Vision are presenting. If you are attending SCDM don’t miss this session!

Title: The Importance of Having Clinical Data Managers as a Key Part of the Protocol Design Process
Date & Time: October 9th at 3:00pm

More about the session:

Clinical Data Managers (CDMs) have an expanded role in today’s world. They are becoming Clinical Data Stewards responsible for the lifecycle of clinical data from collection to analysis and submission to regulatory authorities. The most important part of the clinical data life cycle is the collection of the data. If the data is collected in a well curated manner using Quality by Design principles, the downstream flow of data and subsequent processing for submission becomes smooth. The data collection phase is largely governed by an optimal protocol design.

In the past, CDM had little say in the protocol design, especially when working with a sponsor. Clinical data managers received a final protocol with limited capacity for study design modification and in many instances were obliged to use creative ways to remedy potential data collection issues due to sub optimal protocol design. When Clinical Data Managers have a seat at the table during protocol design they can identify potential protocol design issues based on their knowledge of managing the clinical data lifecycle. This session will present on the ground situations where sponsors/CROs have successfully incorporated CDM feedback to achieve optimal protocol design.