Freelancer / Consultant / EDC Developer / Clinical Programmer

* Setting up a project in EDC (Oracle InForm, Medidata Rave, OpenClinica, OCRDC) * Creation of electronic case report forms (eCRFs) * Validation of programs, edit checks * Write validation test scripts * Execute validation test scripts * Write custom functions * Implement study build best practices * Knowledge of the process of clinical trialsContinue reading “Freelancer / Consultant / EDC Developer / Clinical Programmer”

Solving Data Collection Challenges

Cross-partnership between sponsors and CROs for the collection and analysis of clinical trial data are complex. As a result there are a number of issues encountered during the running of  trial. As with many projects, standardization projects like CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) hasContinue reading “Solving Data Collection Challenges”

CDISC/CDASH Standards at your Fingertips

A standard database structure using CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can facilitate the collection, exchange, reporting, and submission of clinical data to the FDA and EMEA. CDISC and CDASH standards provide reusability and scalability to EDC (electronic data capture) trials. There are some defiance in implementingContinue reading “CDISC/CDASH Standards at your Fingertips”

Professional Timeline – Clinical Programmer

Professional Timeline   anayansi gamboa

SDTM Terminology

The current version of the Study Data Tabulation Model Implementation Guide Version 3.1.2 (SDTMIG v3.1.2) answers to CDSH questions to comply with SDTM terminology. Some key points to remember: You need to define which codelists will be applied to which questions Most data entry systems require a concise list of potential terms per variable/field SDTMContinue reading “SDTM Terminology”

A New Way to Collect Data – CDASH

There is a general consensus that the old paper-based data management tools and processes were inefficient and should be optimized. Electronic Data Capture has transformed the process of clinical trials data collection from a paper-based Case Report Form (CRF) process (paper-based) to an electronic-based CRF process (edc process). In an attempt to optimize the processContinue reading “A New Way to Collect Data – CDASH”