Tag Archive: clinical trials

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.

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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.

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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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The Experience Matters.

As an industry leader in business process outsourcing, C3i Solutions delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

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