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

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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.

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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.

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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.

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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.

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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.

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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.

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Improving Veeva CRM Support Resolution Rate

Best Practice: Improving Veeva CRM Support Resolution Rate

/ Nov 20, 2017

How improving your Veeva CRM support resolution rate can lead to increased sales force effectiveness.

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FDA Adverse Events Reporting System (FAERS)

/ Nov 16, 2017

FDA operates one of the largest and most complete databases of adverse events on drugs marketed in the US. FAERS data is now easily searchable online.

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