The adverse effect reports (AERs) must be translated from the local language to English, with care being taken to ensure that patient confidentiality is not breached at any point.
St. Paul, MN (PRWEB) August 19, 2013
Merrill Brink International, a leading global provider of language solutions for global companies and law firms, today announced that it has published a new white paper, “Pharmacovigilance: Five keys to language transparency and optimized reporting.”
Pharmacovigilance is gaining global attention as a multi- and cross-area discipline that deals with the incidence and frequency of adverse events related to pharmaceuticals and medical devices worldwide. The reporting of these events is critical to building a valid pharmacovigilance program that can effectively identify issues before they impact public health.
However, language can be a barrier in reporting. In many instances, adverse events and databases are reported in the local language. The adverse effect reports (AERs) must be translated from the local language to English, with care being taken to ensure that patient confidentiality is not breached at any point. Eventually, these reports are translated into multiple languages to meet various countries’ requirements. How prepared is your organization to address pharmacovigilance standards? The white paper addresses the following questions:
- Does your organization have a formalized process for adverse event reporting?
- Is your team trained in maintaining patient confidentiality?
- Who is responsible for translating the AERs? Are the translators certified medical translation specialists?
- What quality control protocols are in place to ensure that AER reporting is accurately captured and translated?
- What financial and operational benefits can a language services provider offer?
Download Merrill Brink’s white paper, “Pharmacovigilance: Five Keys to Improving Language Transparency for Optimized Reporting,” to learn more about global pharmacovigilance and how your organization can be optimally prepared for compliance.
About Merrill Brink International
Merrill Brink International (http://www.merrillbrink.com) is a leading provider of complete translation and language solutions for global companies and law firms, with special expertise in serving the legal, financial, life sciences, software, heavy machinery and corporate markets. A proven leader with more than 30 years of experience, Merrill Brink offers a wide range of language solutions including translation, localization, desktop publishing and globalization services.
Merrill Brink is recognized in the industry for its commitment to quality and its pioneering approach of leveraging technology to reduce costs, eliminate redundant processes and accelerate translation life cycles. Merrill Brink is certified to ISO 9001:2008; ISO 27001:2005 and ISO 13485:2003, and registered to EN 15038:2006 and ISO 14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed. Merrill Brink International is a wholly owned subsidiary of Merrill Corporation.