When it comes to safety, PRA puts its patients and its people first. Clinical trials are meticulous, with many moving pieces and crucial steps. It’s important that each piece of a trial contributes in a meaningful and safe way.

PRA Insights Team
PRA Insights Team

For Patient Safety Week, we spoke with our experts to hear their thoughts on pharmacovigilance, patient safety, and what we can all do to ensure that drug developments remain safe and effective.

Catherine Godfrey Title

In your own words, what does pharmacovigilance and patient safety mean, and what do they entail?

As pharmacovigilance and patient safety experts, we ensure patients can benefit from treatment with medicinal products (including devices) while minimizing the risks associated with them.

It starts as early as exposure to medicinal products during clinical trials. It continues post-marketing once a product is approved and until it is withdrawn from the market. Pharmacovigilance and patient safety require resources, processes, and technology to collect and evaluate adverse events. We identify, manage, and minimize safety risks as well as communicate safety information to regulatory authorities, health care professionals, and patients.

What is PRA doing to promote patient safety within our Pharmacovigilance and Patient Safety Unit (i.e. main initiatives, goals)?

Over half of adverse events are preventable - what is the industry missing? How can we work to get these numbers down? What is typically preventable/what is not?

What does the healthcare industry/the CRO industry need to keep top of mind to keep patients safe?

How can the public become more aware of and more involved in patient safety initiatives?

It’s key to have a cross-functional team approach to mitigating and solving complex patient safety issues. Engaging subject matter experts from multiple disciplines enables better decisions that impact patient safety.

Catherine Godfrey, Executive Director, Patient Safety, Pharmacovigilance & Patient Safety

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In your own words, what does pharmacovigilance and patient safety mean, and what do they entail?

It means identifying the balance of safety and adverse events from drug exposure vs. the benefit of efficacy and treatment. Our bioanalytical teams work every day to assess Pharmacokinetic (PK) end points (what the body is doing to the drug), Pharmacodynamic (including biomarkers) end points, and both the safety and efficacy of the drug (what the drug is doing to the body).

Additionally, we often support drug-drug interaction studies (the understanding of what drugs are), perpetrators, and which drugs are victims of interaction with concomitantly administered therapies. When we do this right—by developing robust, validated-methodologies capable of elucidating this information in each sample—we’re able to create critical data that can be used to make adjustments or assessments that directly affect patient safety.

The biolab can start this as early as pre-clinical development in toxicologically/pharmacologically relevant species, and helping considering safety in dosing human patients. The process continues for us through the stages of drug development, and we do this by providing high-quality, science-driven results back to our sponsors and clinical teams. Finally, we also partner with key clients to oversee continued monitoring on their marketed products through other outsourced vendors.

What is PRA doing to promote patient safety within our laboratories and clinical research centers (i.e. main initiatives, goals)?

What does the healthcare industry/the CRO industry need to keep top of mind to keep patients safe?

How can the public become more aware of and more involved in patient safety initiatives?

Behind every sample waiting to be analyzed, there is a patient waiting to be treated.

Jason N. Neat, Executive Director – US Lab

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In your own words, what does pharmacovigilance and patient safety mean, and what do they entail?

Pharmacovigilance and patient safety includes the people, processes, and tools that monitor and improve drug safety through clinical trials and after a drug has been marketed.

What is PRA doing to promote patient safety within our Pharmacovigilance and Patient Safety Unit (i.e. main initiatives, goals)?

Over half of adverse events are preventable - what is the industry missing? How can we work to get these numbers down? What is typically preventable/what is not?

What does the healthcare industry/the CRO industry need to keep top of mind to keep patients safe?

How can the public become more aware of and more involved in patient safety initiatives?

A patient/consumer is the most important commodity in the drug development process.

Brian Guza, Vice President, Pharmacovigilance and Patient Safety Technology

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