eCRF Design and Programming, data validation, data cleaning, data review, coding of medical terms, external data transfers, Database Lock
Protocol Design, Sample Size estimation, Statistical Analysis Plan, Tables/Listings and Figures, Efficacy and Safety Analysis of the Clinical Study data, Statistical Analysis Report
SDTM Annotated CRF, Specifications File, Programming of SDTM Datasets, QC of SDTM Datasets (Pinnacle21), define.xml metadata file, SDRG
Shell of Tables, Figures and Listings (TFLs), Statistical Programming Plan, Program and Validate statistical programs (TFLs), ADaM Specifications, Programming and Validation of ADaM Datasets
Flexible Outsourcing: Clinical Data Managers, CDISC-SDTM Specialists, Biostatistics, Quality Assurance
We are a Contract Research Organization (CRO) specializing in Clinical Data Management, eCRF design and programming, Biostatistics, and the implementation of Clinical Data Standards (CDISC CDASH and SDTM). Our services also include Quality Assurance and Outsourcing for Clinical Trials across Phases I–IV, as well as Epidemiological Studies, Real-World Evidence (RWE), and Outcomes Research. We operate in Latin America and serve clients worldwide.
We work together with Pharmaceutical and Biotechnology companies, and other Contract Research Organizations (CROs) in Clinical Data Management, standardization of clinical data and tabulation of gathered raw data to the CDISC-SDTM standard, which allows them to successfully complete Regulatory Submissions in Electronic Format to FDA and other Regulatory Agencies.
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.
See our Confidentiality Policy
Thank you for your interest in R&DP. We have received your resume and will be in touch if your profile matches our job opportunities.
See our Confidentiality Policy
Fill out our entire form to contact us and we will respond as soon as possible