February 24, 2020 | Uncategorized | No Comments
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
Pharmacovigilance being an extensive part of healthcare and clinical trials requires the combination of deep understanding of medical translation with the intricacies of clinical research, marketing and reporting. Some countries have made the reporting in their local language mandatory.
The Need for Multilingualism in Pharmacovigilance
There’s a growing urgent need for accuracy in translation of clinical documentation and reporting; from pre-marketing clinical testing, adverse event / pharmacovigilance reporting, coding and word-to-word documentation. For some regulators, there is a requirement for the data to be processed and reported in their local language.
For countries like Japan and China, new rules for pharmacovigilance are on the way. CROs, biotech and pharma companies from these countries will soon be required to submit their regulatory reports in their national languages by the end of 2020.
The existing traditional systems can only support English as the language and even if some systems have the capability to provide a setup for any other language such as Chinese, Japanese, etc. or can convert a language into another, they tend to charge a substantial cost for the same.
Multilingual system would also be of great use as the local pharmacovigilance employs of these countries can complete all the processes efficiently and in little time when provided with an ease of their local language on the PV systems.
Not only in Japan and China, but multilingual PV systems would be extremely beneficial to all the countries in all parts of the world.
Clinevo Safety & It’s Multilingual Capabilities
Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end to end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case processing, Regulatory submissions / AS2 gateway, Analytics, and Safety signals capabilities under one platform.
It is supported by technology that enables quick turnaround of your specialist requirements. Clinevo Safety can process data in any language like German, Japanese, Chinese, etc. The complete system gets adopted to any language with just an admin configuration.
Apart from just multilingualism, Clinevo Safety also offers dual language support where all the text is available in two different languages and these languages can be set according to the user preference. The multilingual and dual language capability of Clinevo Safety makes it a language friendly, efficient and cost-effective multilingual global system.