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Research &
Data
Processing

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CDISC-SDTM

Data
Management

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Bioestadística

Safety Management

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Experticia

LA EMPRESA

Somos una empresa de servicios para la Investigación Clínica enfocados en proyectos de conversión de datos (raw data tables) a datos tabulados CDISC-SDTM, Clinical Data Management y Bioestadística, en Latinoamérica y el resto del mundo.

¿QUIÉNES SOMOS?

Jorge Abate, 
CCDM, MBA

Clinical Data Manager & Clinical Data Standards Manager

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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.

Lucila Blanco, PhD

Biostatistician

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Biostatistician with many years of extensive application of statistical analysis for health-related studies including data from multiple clinical trials, longitudinal epidemiology studies, and surveys, which have demanded substantial use of statistical software packages, such as SPSS and SAS.

 

More than 30 years as a Professor of Statistics at the School of Medicine of the Central University of Venezuela.

 

Authored/co-authored numerous scientific publications in peer-reviewed journals. Strong background in the application of general linear models, categorical data analysis, survival analysis, multivariate analysis, longitudinal data analysis, as well as power and sample size determination.

Jairo Rojano, 
MD, MsC

Medical Advisor

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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.

Geraldine Morales, Pharm

Quality Assurance

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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.

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