Case Study: Clinical Study Translation For CHDI
Language Connections has years of experience providing life science translation services for global clinical studies that are essential for drug approval. The need for high-quality language services to reach global patient populations is critical, especially when it comes to clinical study translations. CHDI Foundation (CHDI), a large nonprofit biomedical research organization, has relied on our team for over a decade to provide clinical research translation services for various clinical study and trial documents.
CHDI supports and conducts research that furthers the collaborative development of therapeutics that can slow the progression of Huntington’s disease, a genetic neurodegenerative disorder that affects muscle coordination and results in cognitive decline. CHDI conducts a number of studies, including the Enroll-HD observational study and clinical research platform at 155 clinical sites in 23 nations across the globe. For over a decade Language Connections has been translating into multiple languages relevant clinical trial documents such as protocol summaries, clinical trial site agreements, as well as patient information sheets (PIS), informed consent forms (ICF), and other types of enrollment documentation to support this vital transglobal work.
LEGAL CHALLENGES
Due to legislative differences and updates to legal language across different countries and localities, clinical trial documents and other forms of documentation need to be carefully updated and faithfully translated to ensure legal compliance.
ETHICAL CHALLENGES
Many study materials need to be translated into local languages and submitted to national and local ethics committees (IRBs) in different countries. Particular attention is given to participant-facing materials to ensure they are easily understood and convey the original intent of the source English language documentation. Where studies involve invasive procedures such as cerebrospinal fluid collection, details of the procedures and associated risks are closely reviewed by IRBs and need to be clear and precise in their meaning.
TIME CONSTRAINTS
One of the constant challenges associated with clinical research translation projects is adhering to a tight schedule without compromising translation quality. This is especially true when translating materials that are frequently updated to reflect regulatory changes.
Language Connections adheres to a methodical and comprehensive workflow to ensure that content undergoes multiple rounds of review before delivery to the client. To meet our client’s needs, we approach clinical study translations using the following methods:
Our Translation Workflow
For less sensitive documents, such as IRB letters, we use a tried-and-true translation, editing, and proofreading process to guarantee the highest translation accuracy. For more sensitive documents, such as ICFs or legal documents, we apply a more thorough industry-standard process that includes translation, editing, and proofreading as well as back translation and reconciliation, both internally and in collaboration with CHDI’s local language experts).
Putting Together a Team
We have assembled a talented team comprised of skilled linguists with experience in life science and clinical translations, as well as experienced project managers to oversee the translation process. Our project managers work closely with CHDI’s clinical program and research managers, language area coordinators, and project managers to confirm all clinical trial documents are translated according to the linguistic and regulatory requirements of different countries. Our team is available to accommodate last-minute changes that need to be made to any translations. Despite the difficult time constraints, our project managers have been able to deliver translations on time.
Thanks to our network of translators and interpreters as well as our skilled project management team, Language Connections has delivered high-quality results for CHDI. The team responsible for procuring and overseeing clinical trial translation services at CHDI has trusted us for over a decade to handle their complex linguistic needs.
Above all, our relationship with CHDI demonstrates Language Connections’ flexibility, attention to detail, and client-oriented approach to providing clinical research translations compliant with the regulatory requirements of different countries.
About Language Connections:
Language Connections is one of the top language service companies in the US. Over the last 30 years, we’ve focused on providing the best business translation services, interpreting services, as well as interpreter training and customized language training programs. In addition to top-tier corporate language training, we offer certified corporate interpreters and professional business translation services in 200+ languages. Our network includes linguists with backgrounds in all major industries. They’re ready to meet your needs, whether they’re for technical translation services, legal translation, government translation services, international development translation services, education translation services, life sciences translation, clinical study translation, or something else. Reach out to us today for a free quote on our cost-efficient and timely translation services, interpreters, or other linguistic services.
Language Connections Inc.
2001 Beacon Street, Suite 105,
Boston, MA 02135
Phone: +1-617-731-3510
Email: service@languageconnections.com
