When is a Signal Not a Signal?

When is a Signal Not a Signal?

/ Jul 18, 2018

Bart Cobert highlights the intricacies of signal detection. Including those instances in which a signal may not be a signal.

Read More

DMCs and SACs

/ Jun 07, 2018

Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).

Read More
Data Security, Protection and the US-EU Privacy Shield: Part 2

Data Security, Protection and the US-EU Privacy Shield: Part 2

/ May 07, 2018

Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance

Read More
Medical Monitoring 101

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

/ Apr 26, 2018

Exploring the role of the Medical Monitor in the clinical research process.

Read More
Focus on the Patient

Patient Engagement Keys to Success: Focus on the Patient

/ Apr 23, 2018

When developing a patient engagement program, focus on the patient.

Read More
Data Security and Privacy Part 1

Data Security, Protection and the US-EU Privacy Shield: Part 1

/ Mar 29, 2018

Bart Cobert reviews the HIPAA and current EU data privacy system and their impacts on drug safety and PV.

Read More

Going 75 Miles an Hour

/ Feb 15, 2018

Bart Cobert explains the risk to a company when drug safety and PV are not done correctly.

Read More

Expanded Access Trials, IITs and Safety Risks

/ Jan 25, 2018

Bart Cobert examines expanded access/compassionate use trials and investigator initiated trials in light of the FDA’s revised guidance, issued in October 2017.

Read More
EMA Move

EMA Move – The Details

/ Dec 19, 2017

It’s decided: the EMA is moving to Amsterdam, The Netherlands by March 30, 2019. Less than two years away. Bart Cobert highlights the PV/Drug Safety concerns of the EMA move.

Read More

Blog Signup