Discover how to track the moving parts involved in translation for multinational clinical trials.
Ensuring the success of a clinical trial, especially on a global scale, requires meticulous planning and precise execution. One crucial element is the accurate and effective translation of all trial-related documents.
This process begins with initial regulatory approvals for medical devices and cutting-edge pharmaceuticals and extends to the business plans and market strategies for these products.
Medical translation services are essential to ensure that the parameters and results of clinical studies are communicated clearly in multiple languages.
Here are five steps to help your company maximize the effectiveness of multinational clinical trial translation.
1. Involve Your Translation Team Early On
When setting up a clinical research trial in a foreign country, involving a medical translation service from the outset can ensure that all relevant documents are accurately translated into the necessary languages.
That includes:
- explanatory brochures
- informed consent form (ICF)
- documents pertaining to clinical protocols
Engaging a translation team at the beginning of a medical trial (or better yet, before it starts) helps address linguistic or regulatory challenges early on, keeping translation costs low and facilitating the successful completion of your multinational clinical trials.
2. Use Tools to Ensure Accuracy and Consistency
Medical translation services strive for accuracy and consistency when translating documents like:
- informed consent forms
- patient questionnaires
- clinical trial protocols
- clinical outcome assessments (COA)
- patient reported outcomes (PRO).
Having the proper terminology, translation databases, expert translators and reviewers will turn what seems to be a challenging project into a manageable one. Set up translation memory and management system tools before the project starts.
Make sure your medical translation provider utilizes professional in-country translators. No one knows languages better than native speakers as experts in their fields.
3. Look For ISO 9001 Certified Translation Services
ISO 9001 certification is another measure to gauge a company’s aptitude for delivering consistent work.
These certified companies also paying attention to the customer’s needs.
It’s an official standard that speaks to the ability of a company to provide dependable, high-quality medical translation.
4. Utilize Standardized and Localized Case Report Forms
If you, or the sponsor of the clinical trial, use paper or electronic case report forms (CRF), don’t underestimate how important the translated details in the forms are to your clinical trial.
Use standardized forms to adhere to the FDA’s Clinical Data Acquisition Standards Harmonization (CDASH). Where appropriate, use localized translated versions of these CRFs.
Your medical translation service can guarantee your CRO records accurate patient information across international borders.
Where appropriate, localized versions of these data from patients speaking different languages will be used. Localization comes into effect when dealing with with differences in cultural and medical practices in different countries.
Standardized case report forms are the base to start from, making sure a consistent document applies across different regions. That includes:
- numbering
- fonts
- layout
- prompts
- question formatting
- instructions
Clear protocols and data collection methods ensure participants understand the trial requirements, regardless of their language.
This clarity simplifies the information provided and enhances data accuracy.
5. Manage Multinational Clinical Trial Translation Costs
Integrate translation costs into the overall budget of any multinational clinical trial.
Efficiently managed translation expenses can be offset by lower patient recruitment costs and higher international visibility.
Multinational trials can be more cost-effective than those conducted solely in the US or Western Europe, particularly in regions with lower living costs and less prevalent medical care.
Expanding your recruitment pool to include multiple languages increases potential candidates and reduces recruiting costs.
Medical translation services can help you balance cost structures, leveraging their expertise to optimize your budget.
Find the Best Clinical Translation Service
Medical translation services help you manage your clinical trial translation budgets. They apply their years of experience in the field to your cost structure.
It takes time to find the right balance. Rely on in-country medical translators, in-house translators, a TMS, and medical translation managers. They combine to meld all elements together into a successful multinational clinical trial.
Involve your medical translation team early on in the process. Look for assurances on quality. Focus on the standardized details of the translated clinical trial documents. Work with an experienced, professional translation service.
Get quality work done at competitive rates while putting together your clinical trials.
Contact us today to get started.
