Discover how to track the moving parts involved in translation for multinational clinical trials.
So much depends on getting a clinical trial, and the clinical trial translation, done right.
That begins with initial regulatory approvals for medical devices and cutting-edge pharmaceuticals, and includes the business plans behind the trials and the plans to bring these products to market.
Medical translation services help make sure the parameters and results of clinical studies are well communicated in foreign languages. Here are four steps to help your company get the most out of its multinational clinical trial translation.
1. Involve Your Translation Team Early On
When a contract research organization (CRO) or medical company sets up a clinical research trial in a foreign country, support provided by a medical translation service can help ensure that all of the relevant documents are correctly translated into the necessary languages from the get-go.
That includes:
- explanatory brochures
- informed consent form (ICF)
- documents pertaining to clinical protocols
By working with a foreign translation team at the beginning of a medical trial (or better yet, before it even starts), linguistic or national regulatory snafus that might arise can be dealt with early on.
That should help keep your translation rates and costs relatively low, and enable 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
A clinical trial’s protocols and methods of data collection should be clear for participants to understand.
That is true regardless of the languages they speak. This in turn should make the information provided much easier to work with.
5. Manage Multinational Clinical Trial Translation Costs
Translation rates and costs need to be factored into the overall budget of any multinational clinical trial. Lower patient recruitment costs and higher international visibility can easily outweigh translation costs, if handled correctly.
Multinational clinical trials can run at a much lower cost than trials conducted in the US or Western Europe, especially in regions where the cost of living is lower, and medical care is not as prevalent.
Patient recruitment options grow significantly when opening your search beyond local venues. When your clinical trial is available in several languages, you increase the pool of potential candidates and reduce your recruiting costs.
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.
