As Certified Clinical Data Manager -by Society for Clinical Data Management-, Jorge Abate has experience in Data integration projects (CDISC-SDTM), Data gathering, clinical trial database management, data cleaning, data tabulation. Subject Matter Expert: CCDM Exam Reviewer (SCDM, 2017-2018) and CDISC-CDASH Volunteer (CDISC, since 2018), Phase I - IV studies, CRO Oversighting.

Biostatistician with extensive experience applying statistical methods to clinical research, including Phase I–IV trials, longitudinal epidemiologic studies, and health surveys. Specialized in pharmacokinetic analysis and CDISC standards, including ADaM and SDTM specifications. Proficient in SAS, SPSS, and R for data processing and statistical programming. Strong background in general linear models, categorical data analysis, survival analysis, multivariate methods, longitudinal modeling, and Bayesian modeling for decision-making in early-phase trials. Contributor to numerous peer-reviewed publications supporting clinical development and regulatory strategy.

Service provider in the medical care area: Internal Medicine and Rheumatology. Medical Advisor in health programs, developer of practical guides for the management of rheumatology and internal medicine. Medical Advisor in the scientific research field, health-disease processes, evaluation of the determinants of health and the problems of tropical infectious diseases, neoplasms and chronic non-communicable diseases, seeking the most effective and efficient solutions.

Advice in Quality Control for Clinical Studies and related Standard Operating Processes. Monitoring and surveillance of compliance with Good Clinical Practices (GCP), Local and International Regulations applicable to Clinical Studies. Development and review of standard operating procedures (SOPs) aimed at Clinical Operations in the área of Clinical Research, Clinical Safety and Medical Affairs.