article thumbnail

CDISC standards in clinical research

pharmaphorum

In this blog, we provide an overview of the CDISC standards used in clinical research. For example, an Adverse Events dataset and the variables it contains. Content standards fall under these four stages of the research process: Protocol Representation Model (PRM). Standard for Exchange of Non-Clinical Data (SEND).

article thumbnail

EMA sets out proposals to reform EU’s clinical trials framework

pharmaphorum

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

article thumbnail

An overview of CDISC standards

pharmaphorum

Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it could transform our business by enabling the rapid design and build of clinical trials. Think of an Adverse Events dataset and the variables it contains.

article thumbnail

10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

“Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.

article thumbnail

Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Keep data consistent with the source.

article thumbnail

Theralase Launches Third Clinical Study Site in the US for Phase II Bladder Cancer Clinical Study

The Pharma Data

Their world-class physicians set new standards in comprehensive urologic patient care and continue to innovate with the most advanced treatments backed by clinical research. FACOS, Director of Clinical Research for MU stated “We are excited to work with Theralase for the NMIBC clinical study. Dr. Laurence H.