Hydroxychloroquine: An Effective COVID Treatment the Media Continues to Tag as “A Dangerous Drug”

On Friday, July 31, in a column ostensibly dealing with health care “misinformation,” Washington Post media critic Margaret Sullivan opened by lambasting “fringe doctors spouting dangerous falsehoods about hydroxychloroquine as a COVID-19 wonder cure.” Actually, it was Sullivan who was spouting dangerous falsehoods about this drug, something the Washington Post and much of the restContinue reading “Hydroxychloroquine: An Effective COVID Treatment the Media Continues to Tag as “A Dangerous Drug””

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”

CDISC Training and Support

CDISC Training RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices. The company is headquarter in Panama City and representation offices with business partners in the United States,Continue reading “CDISC Training and Support”

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”

Project Plan: CDISC Implementation

CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research – Project Management. As with many projects, CDISCContinue reading “Project Plan: CDISC Implementation”

CDISC Clinical Research “A” Terminology

acronym: A word formed from the beginning letters (e.g., ANSI) or a combination of syllables and letters (e.g., MedDRA) of a name or phrase. admission criteria:Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristicsContinue reading “CDISC Clinical Research “A” Terminology”