Current CTMS industry trends such as acquisitions, strategic outsourcing, need for operational study data aggregation, metrics and more robust data analytics are continuing to drive standardization and interoperability requirements across the R&D operating model. This includes the need to share data and reporting between systems in an operational manner to more closely manage trial costs and leverage the data strategically.
Some common key CTMS requirements include: budgeting, clinical supplies inventory management, patient management, adherence to GxP regulatory requirements and computer systems validation regulations, and compatibility with other internal (and external) processes and systems.
The Essex team has experience with implementation and development of various CTMS solutions as well as integration across the eClinical Suite (including EDC, CDMS, Safety Reconciliation, Regulatory systems). This includes working in both a project management as well as functional team analysis role to define clinical trial management reporting requirements (including a computer systems validation strategy) and determining adherence to upstream and downstream standards requirements for interoperability. We have also facilitated business requirements gathering sessions and analysis to define reporting and interface data flow requirements across systems
This expertise allows Essex to help our clients move towards true partnership with investigators, faster accrual, better trial data quality, and lower trial costs.
Meet Susan Nonemaker-Cox
Sr. Associate and
CTMS Domain Lead
Susan has over 20 years working in clinical and research IT. She has managed international Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS) implementations working in a regulatory compliant environment and led the Computer Systems Validation practice for a New York-based management and IT consulting firm. She is currently supporting the Clinical Trial Reporting Program at the NCI. Susan holds a Bachelors in Speech Communication with a concentration in Marketing from Shippensburg University.