DATA Management

In the last decade, data management has experienced rapid evolution, driven by innovative processes and high-quality tools. Effective data management is crucial for informed decision-making in today's landscape. Therefore, data collected throughout the product or technology lifecycle must adhere to fundamental regulatory compliance standards that ensure data quality and integrity. Collecting and managing data in accordance with regulatory standards is essential for obtaining complete and error-free information. Product developers must ensure that the data presented to regulatory bodies is reliable and that conclusions drawn during the research and development phase are well-supported by the collected data.

Clinical data management (CDM) is a critical component in advancing products to market. CDM ensures that the data collected is of high quality and that the analytics performed are statistically reliable, supporting effective decision-making. The ultimate goal of CDM is to capture and integrate data from clinical trials to guide treatment decisions that impact patient health.

SOMA Data Management Services

SOMA’s Data Management team provides dedicated services that encompass the entire data lifecycle, from capturing and managing to cleaning and delivering efficient, scalable data. We offer consulting services covering everything from database creation to archiving. Our team is adept at transitioning from traditional paper-based systems to electronic data capture (EDC). We provide customized data solutions that emphasize cost efficiency, data integrity, and accuracy, ensuring all our solutions are compliance-driven and adhere to applicable laws and guidelines from regulatory agencies, including ICH GCP and 21 CFR Part 11.

• Technical and Procedural Requirements: This regulation outlines the standards for firms that choose to maintain records electronically and/or use electronic signatures.
• Predicate Rules: Part 11 serves as a companion to other FDA regulations, addressing specific requirements related to recordkeeping, content, signatures, and retention.

• Electronic Case Report Forms (eCRFs)
• Electronic Patient Reported Outcomes (ePRO)
• Interactive Voice Response Systems (IVRS)
• Adverse Event Reporting Systems (AERS)
• Laboratory Information Management Systems (LIMS)
• Integration Systems: Solutions that automatically record data from medical devices such as ECGs, Holter Monitors, and MRIs.

With SOMA's comprehensive data management services, you can ensure high-quality data handling that meets regulatory standards, ultimately supporting successful product development and market readiness.