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Meet the Global Head of Bioclinica's Pharmacovigilance and Regulatory Operations

Aman Wasan heads Bioclinica's Safety & Regulatory Services and also serves as Country Head for India Operations. Bioclinica offers specialized pharmacovigilance (PV) services including end-to-end case processing, aggregate reporting, signal detection/assessment and safety call center services to biopharmaceutical organizations across the globe. Bioclinica also specializes in PV as a Service (PVaaS) and as a traditional on-premise model. With PVaaS, we manage all aspects of PV from application management and hosting through to business process support, on behalf of some of the global biopharmaceutical organizations.

Aman WasanPreviously, Aman worked in companies such as Novartis and various other global organizations, and his career experience includes assignments within Europe and the US where he led a variety of key clinical development programs and process optimization initiatives. Under Aman's leadership, Bioclinica's PV services have grown substantially with the addition of a number of global biopharmaceutical organizations as its customers. In recent years, Bioclinica has managed to establish itself as a specialized PV service provider and a preferred employer for highly skilled health care professionals.

 

Here, we asked Aman a few questions regarding his view of the PV landscape.

What's the greatest PV challenge(s) facing the industry today?
PV is a highly-regulated domain, and even minor changes to global regulations can impact day to day processes. Our work directly impacts patient safety, and this makes it even more important to ensure that all processes are in compliance with global regulations at all times. The greatest challenge facing the industry today is bringing efficiency to safety processes so that critical side effects of the drugs can be identified early enough in the development phases, enabling cost-effective, safer and efficacious drugs for patients.

In what ways has the PV landscape changed during the past decade?
This industry has seen a lot of changes in the past decade. Earlier, pharmaceutical companies had concerns about outsourcing PV activities due to data privacy and other challenges. The industry initially opened up with targeted outsourcing of a few PV activities, and now we can see the full gamut of outsourced PV services across the globe.

How do you see PV evolving in the future?
Within the next few years, I see the PV industry evolving with technological advances in the field of automation/artificial intelligence, particularly in ICSR case processing. There have been various attempts in the past at automating ICSR case processing. However, since PV is a highly-regulated field, any attempt at introducing automation must be properly validated and should not have any impact on the quality of safety information and compliance with health authority requirements. Bioclinica is working with its partners on some of these initiatives.

Can you tell us how our PV offerings differ from others?
Bioclinica's approach towards PV is focused on operational excellence. Patient safety is our core objective, and we have built highly efficient processes to achieve this. Starting with a focused approach towards training and its effectiveness, robust quality and compliance processes, our experienced PV leadership team enables an efficient governance model, onshore PV subject matter experts as engagement managers who are closely integrated with the PV operations team and best-in-industry employee satisfaction and engagement processes leading to a highly skilled and stable workforce.

Today, we are considered one of the leading PV service providers globally.

Is there anything from your own experience that you'd like to share with other PV professionals?
Anyone working in PV must have a working understanding of clinical research processes and the flow of information within the clinical research domains such as clinical operations, clinical data management, regulatory affairs and PV. It is extremely important for all PV professionals to understand that patient safety is paramount and each activity performed in the PV domain can directly impact patient safety.

Anything particularly rewarding about working in this field?
The best reward for working in PV is that one is close to the new advances in drug development and medicine.

For more information about Bioclinica's Safety & Regulatory Services, please contact Aman
at aman.wasan@bioclinica.com.

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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