A new FOIA production exposed a political motive behind the CDC shifting the goalposts on the definition of ‘vaccine’ and ‘vaccination’. #CDCVaccine #CDC #Covid19 POSTED: November 5, 2021 Source: The Highwire with Del Bigtree The Europe News, [Nov 7, 2021 at 7:04 AM] BREAKING: CDC Emails prove that the definition of „vaccines“ was just aContinue reading “CDC CAUGHT SHIFTING THE GOALPOSTS [Vaccine Definition]”

BREAKING NEWS: Pfizer falsified vaccine trial data.

BREAKING NEWS: Pfizer falsified vaccine trial data. “But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that theContinue reading “BREAKING NEWS: Pfizer falsified vaccine trial data.”

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”

Got EDC?

Clinical trials play a key role in the pharmaceutical, biotechnology and medical device industry. With a large number of drugs coming off patent, companies are under pressure to develop and test new drugs as swiftly and efficiently as possible. This requires an increase in clinical trials and a reduction in the time cycle of thoseContinue reading “Got EDC?”

Good Programming Practice for Clinical Trials by Sunil Gupta

The following are draft recommendations a Good Programming Practice for analysis, reporting and data manipulation in Clinical Trials and the Healthcare industries. The purpose is to encourage contributions from across companies, non-profit organizations and regulators in an attempt to create a consensus recommendation. The ambition is that this page becomes recognized by the Pharmaceutical Industry,Continue reading “Good Programming Practice for Clinical Trials by Sunil Gupta”

CDISC Will Be Required by Kit Howard

Over the past decade or so, a tremendous amount of development work has gone into creating standards for data to be submitted electronically to the FDA. There are those, however, who question whether these standards will ever be required, and believe that unless the FDA requires them, the standards don’t have to be adopted. Indeed,Continue reading “CDISC Will Be Required by Kit Howard”

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”