Tag Archive: clinical trials

Clinical Trials & REMS in the Time of Corona: FDA & MHRA Advice and Guidance

Pharmacovigilance expert Bart Cobert discusses the FDA and MHRA guidance for non-Corona related clinical trials.

Clintrials.gov Update

Bart Cobert on the importance of publishing clinical trials data and implications on pharmacovigilance.

Reporting and Not Reporting Data

Bart Cobert discusses the importance of clinical safety reporting. Not only is this a legal responsibility but also an ethical one.

Patient Centricity in Clinical Trials

Patient engagement technology is critical to the needs of the pharmaceutical industry, and thus, patient centric clinical trials are the way forward.

Safety Reporting: Why We Do What We Do

We participate in safety reporting not only because it is required by law, but because we are HCPs whose first duty is always to protect the patient.

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

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

Drug Safety and AEs in Children

As the saying goes, children are not small adults. Thus the approach of pharmacovigilance to AEs in children needs to be different from that in adults.

Phase I Disasters … And Some Good News

Every couple of years, the pharmacology world reads about a phase I trial that has significant problems or is a frank disaster.

Remote PV Audits & Inspections

The advantages and disadvantages of remote audits and inspections – also called virtual inspections, distant inspections, paper inspections, web inspections, and telephone inspections.

The Clinical ‘Connectors’ for Escalation Services

Soniya Patel highlights the importance of medical escalation procedures during a clinical trial.

The Experience Matters.

As an industry leader in business process outsourcing, HCL Technologies delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.