Post-Authorization & Marketed Products
Specific Ways We Can Help.
Batch records
- We can implement our custom AI to handle almost any format, including handwritten. And with 20+ years of experience, we’re more than familiar with the shorthands and specificities of terminology deployed in these records.
Logistics & distribution
- We can translate guidance to ensure your supply chain adheres to Good Distribution Practice standards, and help keep you on top of regulatory and local changes.
Pharmacovigilance reports
- Working with our in-country linguists, we can help you communicate meaningfully and clearly with patients and HCPs in all languages and cultures, to ensure safety and avoid misunderstandings.
Adverse event reports (AERs)
- Large volumes of data, inconsistent formats, and rapid turnarounds… We leverage AI OCR, workflows, and assisted translation to return accurate content to you in a fraction of the time.
Periodic safety update reports (PSURs)
- We can translate this key document for regulatory bodies around the world, and can also help with any subsequent labeling updates.
Risk management plans (RMPs)
- We translate your RMPs for regulatory bodies and HCPs internationally. We can isolate updated content for translation and maintain careful version control, so all language versions remain consistently live and up to date.
Overcoming the Challenges of the Post-Authorization Stage.
One of the major challenges of the post-authorization stage is the data. Data in this phase comes from multiple sources, is often recorded manually, and is not always easy to interpret. We work with AI tools that enable us to translate any format, and have experienced linguists working in 330+ language combinations.
Timing is absolutely of the essence in this phase, especially in the case of rare adverse events reporting. We implement our linguist allocation and efficiency tools to rapidly translate and review this highly time-sensitive content.
The sheer volume of information and the human resources required to parse said information are major challenges, as are the costs that come with that resourcing. Our clients give us their multilingual data, so we can apply custom workflows and AI tools to deliver fast, accurate translations at scale.
The key to this entire phase is to maintain lines of clear communication across all stakeholder groups, especially when communicating findings back to HCPs and the public. Information must be conveyed in a way that is clear, ensures safety, and avoids misinterpretation. Which is where having access to our trained linguists on the ground in 110 countries becomes a major asset for our clients.
Why Work With Us.
Trusted by organizations all over the world
Case Studies.
FAQs.
Costs and timelines for translation depend on factors like language combinations, volumes, and service level.
If you would like to get an idea of costs and timings for your work, please get in touch and we will be delighted to produce a quote for you.
Yes, where appropriate, we use AI tools for translation and workflow management. We will only use AI where it adds value and will advise against when it does not.
If you would like to understand the potential value of AI for your work, please get in touch and we will be happy to perform an assessment for you.
Conversis is certified to ISO 9001, 17100 & 27001 standards. These certifications attest to our rigorous quality, security, and translation management processes.
To get started, please complete our contact form and we will be in touch to set up an initial conversation. We look forward to speaking with you!