How machine translation fast-tracks pharmacovigilance regulatory reporting without cutting corners
3 mins
In the world of pharmacovigilance and drug safety, speed and accuracy are critical to ensure all new drugs coming to market are safe and effective. With so little margin for error, pharmacovigilance is an area perfectly placed to reap the benefits of integrating AI-powered machine translation solutions into its workflows.
As the scope of pharmacovigilance rapidly increases, so do the reputational and financial costs of contravening its accompanying regulations. With the typical phase III study being conducted in over 30 countries, a vast number of safety reports and related materials are generated from sites around the world.
This means the pressure is on life sciences organizations, pharmaceutical companies especially, to ensure their workflows keep pace and that patient safety remains front and center in the effort to bring new drugs to global markets.
A key area in which this challenge manifests is data and document translations. Already a critical part of pharmacovigilance, the need for faster, highly accurate translations is magnified when you look to scale your operations across geographies, legal jurisdictions, and regulatory bodies, such as the European Medicines Agency and the FDA’s Center for Drug Evaluation and Research (CDER).
This is where AI-powered machine translation (MT) holds the potential to prove a transformative tool. It revolutionizes pharmacovigilance efficiency and provides your organization with the capability to massively scale its operations in this space.
The impetus to shift to machine translation
The fact that lives are literally on the line as part of your pharmacovigilance reporting underscores the need for seamless communication across any linguistic barriers that appear. However, traditional, human-based translation methods pose significant challenges to globally minded pharmacovigilance operations:
- They are slow. Human translators peak at around 3,000 words per day, and while the quality of output is high, this lack of speed does hold the potential to jeopardize timely adverse event reporting (AER), for example.
- They are difficult to scale. Whenever a new language pair is needed for translation, perhaps due to entering a new market, a new translator is needed. Your company will also need to source enough experts in the new language to counter the ~3,000 word per day upper limit.
AI-powered MT removes these obstacles at a stroke. Powered by advanced algorithms and deep learning techniques, it can recognize and store specific pharmaceutical terminology and intricacies.
This means it instantly translates safety reports, adverse event data, regulatory documents, and medical literature in huge volumes across many thousands of language combinations. Add in the strict data security built into certain enterprise-grade, i.e., not free and available online translation tools, and MT not only expedites the translation process but also ensures consistency, precision, and continual adherence to industry and jurisdiction guidelines through enabling a streamlined reporting process. All are critical factors in your continued ability to safeguard patient welfare and maintain regulatory compliance.
Does this mean the end of human translators in pharmacovigilance? In short, no. MT is not a wholesale replacement of human translators and you should not think of it as such. It is more accurate to describe it as a tool that assists in the speed of translation, helping to significantly speed up and scale your pharmacovigilance operations.
Human review and validation will always form a key part of educating any AI-powered MT, as it is through this method that MT learns the intricacies of pharmacovigilance language quickest. It is also often necessary to have a human review to maintain compliance with regulatory standards.
Language Weaver is a leading MT solution that can deliver a huge improvement in translation speed and performance across the widest range of geographies and jurisdictions.
Secure-by-design, Language Weaver is used by many of the world’s top pharmaceutical companies, providing over 4,000 language combinations and 150+ direct language pairs into their existing workflows and processes without ever compromising patient data security or confidentiality.
As a highly intelligent tool, Language Weaver can learn industry-specific terminology, nuance, and linguistic intricacies with every use. In doing so, it’s vocabulary and accuracy is continually improved, further improving upon the speed and quality of your translations.
With a translation capacity of 100,000s+ words per minute, it is available in cloud, on-premises, or hybrid deployment models, enabling flexibility to match your needs and specific organizational circumstances.
It’s an essential tool for any globally minded life sciences organization needing to prove beyond any doubt its continual regulatory adherence.
The work of pharmacovigilance teams is of critical importance in clinical development and in ensuring the long-term safety of pharmaceutical products. In the fast-paced and high-pressure world of drug safety, discover the potential of AI-powered machine translation with Language Weaver to deal with the explosion of safety reporting cases while also maximizing compliance and minimizing risk.
Discover the potential of implementing Language Weaver across your entire operations, and how it can rapidly accelerate your teams’ time to impact by visiting our dedicated life sciences landing page.