Adverse events reporting is a part of pharmacovigilance and is relevant to the medical and pharmaceutical industries, but what exactly is it and what has it got to do with translation or transcription services? In this blog, eSense Translations sheds some light on the matter.
What is an adverse event?
BHBIA defines an adverse event as ‘Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment.’
In other words, it is when a patient or clinical trial participant experiences any unusual medical symptoms whilst taking part in a clinical trial. It may be an unfavourable and abnormal finding, symptom or disease that may be temporarily associated with the use of a medicinal product, but may or may not be related to the product testing itself.
When testing new potential medicinal products, the pharmaceutical organisation leading the trials has a legal and regulatory responsibility to report any of these adverse events. This is part of the pharmacovigilance process, where any adverse effects that occur during testing are detected, assessed and fully understood, so that if the medicinal product is placed on the market, any adversity is prevented.
How is adverse event reporting relevant to language services?
Pharmacological trials of medicinal products are often completed with a global market to obtain a full and complete understanding of their uses and effects. Such trials are normally subcontracted to global medical market research companies.
For these research studies to be most effective, they should be executed in the respondents’ native language. This ensures that the respondent has a complete understanding of the study and is able to provide full details in their answers.
Language service providers are then generally engaged to assist in the transcription, translation and/or analysis of the results, including adverse event reporting, once the data has been collected.
How eSense Translations has developed its services to offer the full package to its market research customers.
eSense Translations has a wealth of experience in assisting medical market research organisations with their global research projects.
Working with highly skilled, experienced linguists, our translation and transcription services offer language solutions for global qualitative and quantitative research studies, including in-depth interviews, focus group sessions, online data collection and open-ended survey responses.
Our commitment to quality, as well as providing a time and cost-efficient service has assisted many renowned medical market research organisations deliver successful results to their end clients.
Following market demand, eSense Translations has expanded into offering research services to enable market research organisations to work more efficiently and have just one point of contact for all parts of their research studies.
By partnering with key professional associations within the industry, including MRS, BHBIA and EphMrA, eSense Translations is able to ensure that its services comply with the industry’s regulatory standards and it remains fully up to date with all new developments within the medical market research sector.
As well research services such as content analysis, respondent recruitment and multilingual social listening, our team of linguists are also fully trained in the critical area of adverse event reporting.
eSense Translations and Adverse Event Reporting
With specific BHBIA adverse events training, as well as bespoke project training for each specific trial, eSense Translations is able to offer best practice that is in line with the regulations on pharmacovigilance when collecting, forwarding and managing data relating to adverse events and can maintain complete accuracy and compliance throughout its processes.
If you’d like to know more, please feel free to give our team a call and we’d be happy to discuss our research services with you in more detail.