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Developing Spanish Translations of Study Materials with Quorum Review

The globalization of the clinical research industry demands that companies have the capability of reaching non-English speaking participants that participate in clinical trials. The demand in the industry to be flexible is greater than it ever has been, especially with the undeniable influence of the Spanish language and culture in the U.S. and the rest of the world. Quorum Review, in accordance with its mission of enhancing the clinical research process and providing world-class service to its customers, has established an In-house Translation Team. The purpose of this team is to provide Quorum’s customers with a competitive option for their translations, while fulfilling the main purpose of the IRB: protecting the safety and welfare of the participants.

Quorum’s Translation Team

Quorum’s translators are qualified professionals with training, certifications, and degrees in the field and experience working with both medical and legal documents. Our translators are actively involved in professional associations in order to keep pace with the latest advancements and changes in the industry. Quorum further trains these translation professionals in human research participant protection matters such as FDA regulations, ICH guidelines, and the HIPAA Privacy Rule. For this reason, Quorum's translators are capable of accurately translating study documents with a specialized approach. Conscious of the purpose of each document, and knowledgeable of the regulations governing the same, the Quorum Translation Team provides customers with final products that are accurate in content and participant friendly.

The Translation Process at Quorum

After study materials have been approved by the IRB for their use in a trial, and at the request of the sponsor or investigator, Quorum’s Study Manager forwards the documents to the Translation Team. A translation performed by Quorum’s in-house team assures:

  • Readability: The Translation Team uses the Spanish equivalent of the English eighth-grade level readability measurement used for English versions of Consent Forms. In addition, the team uses a “universal Spanish" (not specific to a particular country or region) in order to produce a document that will be easily understood by all potential Spanish-speaking participants.
  • Compliance with Regulatory Requirements: When translating, the Translation Team takes into account the regulations and requirements that govern that document, including 21 CFR Parts 50 and 56, 45 CFR Part 164, and FDA and ICH guidelines.
  • Speed: The in-house nature of our team allows the document to get where it needs to go faster. Moreover, the Translation Team’s broad knowledge in the field decreases translation turn-around time. The latest computer aided translation software programs further facilitate the translation process and assure consistency on key terms.
  • Consistency: Through the team’s use of computer aided translation tools consistency in language, phrasing and vocabulary can be achieved and maintained. Regular customers receive reliability across all documents every time they request a translation.

The Advantages of Using Quorum's In-house Translation Service

Quorum’s Translation Team works solely with clinical research study documents. As such, the team has developed exceptional proficiency in translating study documents. Quorum’s documents meet all regulatory requirements, assure participant protection, and maintain the content, style and presentation of the English document. An extensive resource library and other electronic tools guarantee the use of the correct Spanish term every time. As an in-house team, the translators are just a few feet away from IRB Members, Regulatory Specialists, and Study Managers for expert consultation guaranteeing the best possible product. Direct communication with the customer through the Study Manager is possible if a question arises in regards to a translation. Finally, proofreading processes and quality assurance checks are also conducted before delivering the final product to the customer.

Quorum Review proudly continues to assure human research participant protection and enhance the clinical research process by offering a highly qualified and specialized service of Spanish translations to its customers.

Contact us with any questions about using Quorum’s Translations Team.

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