Suma Reddy Sama

Background

About Suma Reddy Sama

As an accomplished Clinical Research professional, adept in Medical Writing and Data Management, I bring extensive experience and expertise to contribute to a diverse range of projects and initiatives. • Proficient in ICH GCP guidelines, clinical trial execution, drug development, and the reporting of serious adverse events.• As a skilled professional, I have gained valuable experience in composing narrative summaries and documenting concomitant medications for reported adverse event cases. Additionally, I possess a strong understanding of Human Anatomy and Physiology, which enables me to effectively interpret and communicate complex medical information. • In addition, I have successfully completed industry-based training in designing protocols, informed consent forms, and final study reports. I am proficient in CRF entry and query resolution and have knowledge of 21 CFR Part 11 • As a skilled professional in the field of data management, I possess extensive experience in conducting thorough reviews of case report forms, managing missing CRFs, and performing comprehensive data validation. Additionally, I excel in generating DCFs, tracking them effectively, and resolving any discrepancies that may arise through a combination of manual checks and system analysis. My expertise in adhering to established guidelines ensure that all data is accurate and reliable, providing essential insights for successful study outcomes.• As a skilled and knowledgeable professional, I possess extensive familiarity with ORACLE CLINICAL 4.5.1, INFORM, and sponsor-customized EDC software. My expertise and proficiency make me confident in my ability to make valuable contributions to clinical research projects.