MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.
Chris Lotter
Overview
At MCRA, Chris leads the Data Management operations team that focuses on the entire lifecycle for Data Management operations. He provides guidance on Process improvement, Programming, Data Capture strategies and standards. He also works closely with Biostats operations and clinical development teams and provides guidance on Data science execution strategies.
Sue Latham
Overview
Quality Assurance professional with over 20 years in FDA-regulated industry, including Quality Assurance (QA), Preclinical and Clinical Research. Registered Nurse and ASQ Certified Quality Auditor experienced in conducting all types of GxP audits.
Understanding Patient Access Programs
Watch our recent webinar "Understanding Patient Access Programs", hosted by LSX.
Jocelyn Bailey
Overview
After joining MCRA in 2016, Jocelyn has provided expert leadership within the Data Management department. She is responsible for overseeing the daily activities of the data management team, including development of data management plans, database builds, and standard operating procedures (SOPs). She designs innovative data collection plans, manages quality control of collected data, and creates custom tools and intuitive databases for end-users.
MCRA Overview: 2022 FDA Draft Guidance
The FDA recently put out a new Draft Guidance, entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket