Tag Archive: clinical trials

Patient Centricity in Clinical Trials

This blog was first published November 17, 2017 on the HCL Technologies blog.   It is a self-evident fact that innovation in technology has taken the front page of all industrial sectors as it has always supported to get the output (desired result) in less time, reduced cost and with limited resources. In line[…]

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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.

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When is a Signal Not a Signal?

When is a Signal Not a Signal?

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

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Medical Monitoring 101

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

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

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AEs in Children

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.

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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.

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Remote PV Audits & Inpsections

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.

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The Clinical ‘Connectors’ for Escalation Services

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

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PMCs and PMRs

PMCs and PMRs: Some Good News

Bart Cobert looks at the recent FDA report on Post-Marketing Requirements (PMRs) and Post-Marketing Commitments (PMCs).

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Remote Site Monitoring

Using Remote Site Monitoring to Enhance Global Clinical Trial Productivity

How Remote Site Monitoring can enhance the global productivity — and reduce the costs — of a clinical trial.

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