The Undisputed Leader in Linguistic Validation

Linguistic Validation

The Undisputed Leader in Linguistic Validation

Mapi is more than just a translation company, we are experts in linguistic validation, the process of producing translations of clinical outcomes assessments (COAs) that are appropriate both linguistically and culturally. We were the first company to develop linguistic validation methodology in a coherent manner. We are the authors of the Linguistic Validation Manual for Health Outcome Assessments. Our work directly led to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines.

Mapi has been the leading authority in linguistic validation and cross-cultural adaptation because we understand the complex nature of adapting COAs for inclusion in multinational clinical trials better than anyone else. No other provider in the industry offer the depth of experience and expertise that Mapi provides.

Outsourcing with Mapi

Today's global industry faces a rapidly increasing need for effective COA instrument translation and adaptation, driven by ever-evolving clinical trial challenges, increasing trial internationalization, and the predominant development of instruments in English. This need demands an experienced language services provider with capabilities that can far exceed an in-house team.

Partnering with Mapi means working with the company that literally wrote the book on linguistic validation. We provide thorough assistance to help you develop COA strategies that satisfy regulatory or reimbursement needs. Our experienced teams and extensive capacity can more likely assure successful project delivery within a significantly shorter timeframe than what might be expected of a smaller in-house team, and at a fraction of an in-house system budget.

Outsourcing with Mapi provides you with an array of time-saving support services that ensure validation over a broad range of therapeutic areas. With Mapi's in-depth, first-hand knowledge of local languages, cultures, regulations, and healthcare practices, your instrument will be culturally and conceptually equivalent in all languages, and will be fully compliant with regulatory authority requirements.

Mapi has overseen the translations and adaptations of 2,500 PRO instruments into more than 170 languages, and our 1,000+ PRO linguistic experts work with over 300 annual international studies conducted in more than 100 countries. Mapi puts that unmatched experience to work for you.

Maintaining an effective linguistic validations program can be challenging and time-consuming for in-house teams to complete. Look to Mapi to conduct your linguistic validations within the tightest timeframes and ensure a swift process. Working with Mapi increases the efficiency of your development process and shortens your time to market.

Our linguistic validations ensure that measurement properties are consistent across different language versions of an instrument, and that data is appropriately collected for validation across international sites. We work in close collaboration with the developers of the original instruments, ensuring conceptual equivalence and international harmonization of all language versions.

Global Benefits
We have first-hand knowledge of local languages and cultures, regulations, and healthcare practices. Mapi can implement instruments in multiple countries and multiple languages with relatively minor changes. Mapi maintains and makes available a file storage network for all translated and adapted instruments, allowing clients easy 24/7 access from any location with a secure internet connection. Mapi can assure you of savings in time required to gain product approval, in the costs required to manage the linguistic validation process, and in the overhead of managing the study.

Mapi's Methodology

Our experience and expertise in linguistic validation have led us to develop a series of best practices for COAs, designed with global clinical trials in mind. See the following diagram for an overview of the process we follow when validating study instrumentation:

Only Mapi can supply linguistic validation support at every point of the development process. Our COA Repository (COAR) is an essential resource for storing and actively managing your translations and adaptations. Our extensive network of experts are available around the clock to answer questions, to help you troubleshoot and avoid problems, and offer training to improve your in-house Linguistic Validation capabilities.

With 25 years of experience providing comprehensive linguistic validations, Mapi has long been a trusted service provider for the Life Sciences industry. Let Mapi give you the peace of mind of knowing that an experienced partner is committed to your project at every step of the validation/adaptation process.

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