The Value of Technology in Pharmacovigilance
pharmatechoutlook

Pharma Tech Outlook: Pharma Tech Magazine

The Value of Technology in Pharmacovigilance

James Curtis, Director, Software Development Engineering, UBC

James Curtis, Director, Software Development Engineering, UBC

Effective use of the right technology is key to being competitive in today’s economy. Modern technology offers critical efficiencies and insights as we monitor and evaluate the safety profile of a drug and take steps to mitigate the risks, without which we could not hope to navigate the regulatory landscape in a cost-effective manner. As essential as this technology is; however, it is just as complex and challenging to manage. For a small to mid-sized pharma company, having a trusted partner to take on this responsibility can allow you to focus on what you do best – providing patients with novel and life-changing therapies. There are three things you should consider when choosing this partner.

First, choose a partner that will pay attention to your individual needs. A “one size fits all” approach to software can leave you feeling boxed in, while a “ground-up” development effort is not often feasible. At UBC, we take a custom software platform approach. We build and maintain a set of baseline platforms which encapsulate the experience and expertise of our teams and can be leveraged for all our clients. However, we also understand and expect that the needs of each of our clients are unique, and we are committed to innovating alongside you in your space. Therefore, our platforms are built from the ground up with the highest levels of configurability and customization. Since most of our systems support GxP programs, we have built in features and processes that reduce the burden of validation and therefore the time and cost needed to customize.

" The value of a fine instrument can be experienced only when in the hands of a master "

Second, choose a partner with broad experience in the biopharmaceutical industry. The value of a fine instrument can be experienced only when in the hands of a master. Similarly, your tech investments will only return value when adopted by expert operational teams who are able to realize the full potential of these systems. This means that these systems should be designed and customized with the direct input of those experts who have a stake in the system. At UBC, our technology is purpose-built to underwrite the specific operational services we offer in the pharmacovigilance and Risk Evaluation and Mitigation Strategy (REMS) space. The continual investments we make to evolve our technology incorporates the best practices and expertise of our operational teams. As a result, our tech and our teams grow together as they are battle-tested in the real-world scenarios that matter to our clients.

Third, choose a partner who understands and is committed to data. As the world becomes increasingly more digital, and as our technology supports more of our day-to-day workflows, the amount of data that are produced is truly staggering. Buried deep within that data is the promise of better patient outcomes, faster times to market, and greater cost efficiency, but there are myriad hurdles to realizing that promise. Just because data are in electronic form does not make the information easily accessible, and even if it were, the convoluted landscape of privacy regulations makes the use of that data a daunting challenge. To address these issues, UBC has built a data platform, Mosaic, which brings disparate data together from many different sources into a single linked data model and surface insights while adhering to all necessary regulations.

Making proper use of the correct technologies is crucial to the success of any drug safety program. Finding the correct partner allows you to enjoy that success without bearing the added burden.

Weekly Brief

height: 0px !important;

Read Also

Achieving trial master file quality, timeliness and completeness

Achieving trial master file quality, timeliness and completeness

Susan K. Maue, Designation : Managing Director PharmaLex
Chasing the Miracles of Science to Improve People's Lives

Chasing the Miracles of Science to Improve People's Lives

Paul Rowe, MD, ATSF, Vice President, Head of Global Medical, Immunology, Sanofi
The Evolving Cell and Gene Therapy Space

The Evolving Cell and Gene Therapy Space

Matthew Hewitt, Executive Director, Scientific Solutions C and GT, Charles River
Worldwide Patients' Access to Life- Changing Therapies

Worldwide Patients' Access to Life- Changing Therapies

Kinga Bercsenyi, PhD, European Lead for Precision Medicine & Biomarker Solutions, Cerba Research
3D Bioprinting: Accelerating Drug Discovery

3D Bioprinting: Accelerating Drug Discovery

Itedale Namro Redwan, CSO, CELLINK
Artificial Intelligence and the Healthcare Industry

Artificial Intelligence and the Healthcare Industry

Kelly H. Zou, PhD, PStat, FASA, Head of Global Medical Analytics and Real World Evidence, Viatris