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Pharmacovigilance expert Bart Cobert discusses the FDA and MHRA guidance for non-Corona related clinical trials.
Bart Cobert on the importance of publishing clinical trials data and implications on pharmacovigilance.
Bart Cobert discusses the importance of clinical safety reporting. Not only is this a legal responsibility but also an ethical one.
Patient engagement technology is critical to the needs of the pharmaceutical industry, and thus, patient centric clinical trials are the way forward.
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.
Exploring the role of the Medical Monitor in the clinical research process.
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.
Every couple of years, the pharmacology world reads about a phase I trial that has significant problems or is a frank disaster.
The advantages and disadvantages of remote audits and inspections – also called virtual inspections, distant inspections, paper inspections, web inspections, and telephone inspections.
Soniya Patel highlights the importance of medical escalation procedures during a clinical trial.
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