How to set up and manage clinical trial translations during the international multicenter clinical study

What are the clinical trial translations?

Clinical trials have evolved into an increasingly global matter in recent years, and the tendency to internationalize clinical studies into emerging countries continues. To accurately represent the implementation and results of these trials both translation and localization services will need.

Many times, clinical trial documentation is developed in one country and then implemented in locations with considerably differing languages and cultures. The importance of clinical translations thus becomes a key element in the implementation of these trials and the way life science companies interpret them.

The clinical trial translation is the process of language support during conducting clinical study especially in multinational centers with goals of better understanding all members of the trial and aligning the documents according to local regulatory requirements.

Is it necessary to provide language support during the clinical study?

Of course, if a clinical study is planned to be performed in one country, you know, like the United States, there no could be needed for translations and everything could be in English. But sometimes considering this case you will need patient-faced translations for some local language minorities to improve their understanding of main clinical trial documentation like Informed Consent Forms (ICF). Then conducting a clinical trial even in the US you’ll need translation services.

Another question is running a clinical study in several countries. Truly said, there are fewer chances you can avoid the using of translation but it is possible especially if the clinical study personal has well knowledge in English. In this case, you have to also consider the questions of localization, cultural adaptation, and aligning the clinical trial documentation. For example, if we are talking about questionnaires for patients, translation is required, because the standardized interpretation of results from clinical centers from different countries is important.

But the core issue that couldn’t be ignored is the local regulations and authorities’ requirements to translations of clinical documentation. Pay attention to this question first when planning a clinical trial and check these requirements against the list of countries available for conducting a clinical trial. (Moreover, sometimes FDA requires translations of some clinical documentation, please also check).

Step 1: set up the goals. Assign a responsible person

If after all considerations and discussions the answer to whether we need the translations is yes, you must think about it more thoroughly and outline it in detail. But first of all, we recommend you decide who will be responsible for this area. Preferably choose a member of your team who has ever dealt with translations otherwise you will need to solve further questions by yourself.

Setting the goals we need to ask the fundamental questions. Why do we add the translation process to our clinical trial? What is compulsory and absolutely needed and what is secondary?

Which measures could speed up the main process? How does translation management fit in and work with content management systems, if used? 

Step 2: resources evaluating and budgeting

After we have the goals we need to go further and evaluate our possibilities to reach the goal in the best possible way. Depending on the resources and goals there several approaches could be chosen to work or not with possible vendors and providers.

1. Choose to do it by yourself

This way could be chosen if your company already has a translation and localization department or linguist and all planned activities could be fully covered by them. This variant is often appropriate for large companies or CROs where clinical studies are performed on an ongoing basis with the same set of stakeholders. It’s really necessary to understand this option needs very much language resources in a company with other main business processes. You should think about language specialists in every country where the clinical trial takes place. Also, take care of appropriate quality assurance and local project management.

2. Work with freelancers or a team of translators

This is a more efficient work model if the clinical trial translation is considered more like projects than like processes and translations are not performed constantly. Meanwhile, you need to think about vendor management and relations with timely worked specialists to build a strong team of professionals. Don’t forget about the procedures of freelancers searching, testing, onboarding, and following quality control. As a rule, the main difficulty is in selecting and finding the right experts in the particular subject matter.

3. Work with general middle-sized LSP

This option would be seen as most easy and widespread because you can meet the average language service provider just by going outside and turning the corner or typing a few words in a search browser. But you need to make sure this LSP has a medical or clinical trial department, so they have appropriate specialization. Working with LSP has some benefits.

LSPs ensure consistency. The necessity of consistency for medical translation services should be obvious.

Working with a language service provider helps you save money over time. When your LSP uses and organizes a translation memory (TM) that covers your projects specifically, you will have a glossary of terms that you can refer to and turn in to anyone getting involved at a later time. This will speed up future translation projects. Overall, it’s a subtle choice to work with freelancers or agencies.

4. Work with specialized LSP

One of the special cases of cooperation with the language service provider is a specialized LSP. We mean those who specialize in medical and life science translations and work only in this subject matter and at the same time, they can cover a significant number of languages for translation. As experience shows, the main pros of choosing this type of LSPs are they have more professional specialists including medical professionals and experts, and effectively combine using medical and linguistic specialists to achieve needed results. Sometimes their prices could be a little bit higher than average but it fully compensates for their close attention to your projects.

5. Work with large MLSP (top-10)

Working with Massive Language Service Providers ideally who gets to TOP-10 could guarantee you the expected result, cover even exotic languages, and don’t care about volumes. Be ready to pay the appropriate price for their services and face so-called bureaucracy or slowness due to their size, processes, and involved stakeholders. Often, they subcontract middle-sized or local LSPs. We recommend working with them if you really have huge volumes and complex projects (if you are from the top-10 of the pharmaceutical industry, they are definitely your vendors).

6. Complex approach

Actually, this approach may be the wisest, especially if one or more parameters such as time, volumes, or quality are unstable. For example, if you constantly work with one LSP, from time to time you can involve other LSP or independent contractors for QA purposes to check how is robust your main vendor. Also, it is useful to know that as with the customers it is recommended to have a diversification portfolio, the same with your vendors. Ideally, the most productive vendor in your vendor’s portfolio should have less than 50% of your projects.

Vendor information and tools for evaluation

Well, we determined roughly what type of supplier we need, and now let’s digress and outline what information we should pay attention to and what tools will help us. 

1. General information and company profile

When you analyze your potential vendor the minimum information that could be collected is general information about the vendor with vendor name, address, contact information. One of the initial documents you can request from the candidates is their company profile. Company profile is also a brief description of the potential vendor where vendors’ services, languages, company history, and latest projects could be included. Essentially, the company profile is like a CV for an individual, so a “company resume” can be assessed using appropriate resume selection methods.

2. Customer references

Another document that could be requested is customer references. Referral letters and links to the sources where potential customers recommend your vendor, and actual contact details of those who can give you any kind of feedback — all of mentioned above could be a good proof of professionalism of your vendor. 

3. Case studies

Ask your potential vendor to demonstrate to you their case studies. Case studies help you partially understand how your vendor processes work and look closely at task types, their complexity, and the results. 

4. Questionnaire

But if you want to use the tool to ask the vendor your specific questions beyond the general information propose them to fill out a questionnaire and it will be the shortest and easiest way to obtain needed information. For this, you can use some widespread tools such as SurveyMonkey or Google Forms.

5. RFI

The acronym mentioned above stands for the Request for Information. Depending on your case, it may be worth it to include an RFI Round before working directly with the RFP. The RFI is an initial stage that is good in the next cases:

  • If you already haven’t a shortlist of translation suppliers
  • If you haven’t a clear idea how what your potential vendor should look like

The RFI should have a few generic open-ended questions, but don’t overdo it. The purpose of an RFI is to collect details and pre-qualify potential vendors for the next step. If you ask too many questions, not only will translation vendors be reluctant to reply, but you will also need to spend a lot of time filtering through many of the answers. Also, remember to include general information about your case and your needs. Thus, you are more likely to get useful information.

6. RFP

Request for Proposal is a more considerable way to post your proposal and gather information from your potential suppliers. You need to use translation RFP if:

  • You have still not set up a centralized standard process for optimizing translation costs and monitoring translation suppliers.
  • You are dissatisfied with your current translation process, due to poor translation quality, bad communication, and slow turnaround.
  • You have a specific large-scale project coming up that requires specific experience and expertise

The RFP could be composed in doc or pdf format and published on your website or sent to interested parties. To manage the proposal applying and reviewing process you can simply use a sheet or consider mentioned above cloud-based survey tools or more complex RFP automation software. Please note that using RFP is time-consuming, you’ll need to budget the time for RFI publication (if you’ll decide to use it), waiting for information, analysis for responses, then RFP publication, again waiting for proposals, then again proposal analysis, and finally performing the meeting to choose the winners.

7. Price list

Of course, you will need to compare the rates, and therefore the document package they send you should also contain the price list. Indirectly, you can also evaluate the number of languages and services offered if they were not mentioned in general documentation. Also, a price list could be a part of the Proposal where often each rate is explained and described or something like different pricing plans could be proposed. These are signs that the price may be negotiable.

Step 3: publishing and searching for your request

An important part of the vendor searching process is the allocation strategy that you use for disseminating your request. If no one reads your request you likely won’t receive the proposals you need to make your process competitive and in line with your clinical trial translation project goals. There are several ways you can spread your message:

1. Publish your need on your website

The first step is to create a landing page within your website. Use this page as the staging ground for all information related to the clinical trial translation project and the place that you can direct people to go for that information. Place your RFP or questionnaire on this page as a downloadable file (PDF or DOC formats will be suitable), and when you issue appendices, you’ll add them to this page. In addition to the files for download, including the schedule, contact information, contact preferences, and other basic information.

When you create this page, find sections within your own site to announce it. You can mention it in the “News” section, even on the homepage, or other sections that already see traffic. You don’t like your RFP to be hidden within your site on a page that nobody will ever see.

It is also recommended prompting that vendors interested in submitting a proposal to your RFP register with you in some way so that you can alert them to changes in your RFP and send them addendums. You can ask just to fill in their email with their contact information, but something that enables you to get a headcount as well as their contact information.

2. Use RFP database or RFP cloud-based software

You can find and place your request in a form of RFP at multiply RFP databases or use RFP automated cloud-based software (platforms like Ariba and Coupa). The more times you’ll be mentioned there, the more replies and proposals you can receive.

3. Seek out recommended providers

Not every project has to start from scratch. Ask around the stakeholders you know about their experiences with vendors for projects like yours, see if they can recommend anyone. Find instances of similar services you like and find out who has worked on them. Invite them to bid on your project.

4. Place it through professional social media or associations

Almost every product or service has a professional association to represent it. If you’re seeking clinical translations, you can visit the American Translators Association and try to find appropriate translators or companies there. The same searching could be performed at Proz.com – a professional network of translators and language service providers. Filtering by clinical trials you can find an appropriate pool of vendors.

What information to pay attention to?

Well, we published requests and received information from your potential vendors. And when we review all these company profiles, case studies, proposals, etc., what information we should pay attention to? Remember, we need a high-quality vendor specialized in clinical trial translations and met all our requirements. So, take a look at:

1. General company information

First impressions are very important. So it is definitely worth reading how the company describes itself. What’s their name, their logo, slogan? How do they write their core message and mission? Reading only these first few words you can understand and filter those providers that certainly work with your subject matter and comply with your rules.

2. Company size

Special attention to company size should be paid. If you plan a multicenter clinical trial overseas it’s obviously understood the future vendor couldn’t include only 1-2 persons to cover many languages and time zones. And if the provider states that, then maybe you need to ask additional questions about how they cope with that.

3. Company locations

Again, many company locations (at least 2 offices in different parts of the world) evidence about good connections and well-built network to provide you quality services. Even better if their office’s locations fully or partially will match yours. This could be helpful for solving for example some local regulatory questions. In any case, it is worth thinking about possible connections between your main representatives and translation resources in a particular location to speed up question resolution.

4. Company business processes

This is one of the key points that should be taken into account. Yes, you need to deep into the box and investigate how your potential provider will proceed with your tasks.

Firstly, if the vendor hasn’t outlined processes this means you can receive unstable results with regard to quality, deadlines, etc.

Second, reviewing the process you can find some special features different from general standards. Evaluate whether they help you and add value to your main process (speed up documentation turnover,  resources, and budget savings). At the same time and further, it will be possible to assess how they meet industry standards like ISO 9100 and ISO 17100 and, by the way, have a good opportunity to compare whether the standards are being followed because some companies take efforts to get ISO certification but don’t follow it in everyday projects.

5. Capacity and availability

The company that offers the best quality, capacity, and availability is the best choice for clinical trial translations.

There are a number of factors that should be considered when looking for a vendor for clinical study translations. Some of these factors include:

  • Volume: how many words per day can they translate?
  • Time zones: what time zones do they work in
  •  Language pairs coverage: what languages do they translate from and to?

The translation service provider should have a good understanding of the clinical trial process. They should be able to provide accurate translations in all languages required by the trial. The company should also have a large enough pool of translators to ensure that there are no delays due to a lack of resources.

6. Quality: process description, references, customer satisfaction, tools, certifications, CVs of linguists

A vendor’s quality should also be taken into account when selecting a new supplier. A brand that you can trust is very important when it comes to your supply chain, they are the backbone of your company and they will supply you with quality services.

You can request information about the QA process by contacting the vendor and inquiring about their procedure for validation. How is the quality control of the translations ensured? How they select the linguists for particular projects? What tools are they using to perform Quality Assurance on their projects?

Please take the time to check the references and the recommendations that are cited elsewhere. Check their credentials and send over a CV of each linguist before making a decision The more high-quality linguists they have, the better.

7. Technology

Ask your potential vendor to describe Technologies used for better translations. It could be different types of software and methods.

  • CAT Tools (eg. SDL Trados, memoQ, Transit, OmegaT)
  • Machine Translation (eg. Google Translate)
  • Using of Professional Translators during MTPE (Machine Translation Post-Editing)

A CAT tool is a computer-assisted translation tool, which is often used in the translation industry. The term refers to the use of two or more computer programs to translate text or other content between languages. The acronym stands for Computer Assisted Translation. These tools generally contain a translation memory, dictionary, grammar check. 

8. Data protection

We should not forget that translators are also data processors. They process personal data, which is why they are subject to the same obligations as other processors.
Clinical trials are a big area of concern when it comes to personal data protection.

For example, the European Union has strict standards in place for clinical trials and it is important that we follow these standards when we choose a translation vendor for our clinical trial translations.

9. Price

When you are looking for a translation vendor for your clinical trial translation, it is important to pay attention to the price and rates. When you are choosing a vendor, you should compare their price list with other vendors. The rates per word and the rate per hour are also important factors that have an impact on the final cost of translation.

The prices of different vendors can vary significantly depending on the volume of work they do and discounts related to volumes. Don’t ignore these factors when choosing a vendor as they can make a huge difference in the cost of translation!

Step 4: candidates evaluation and selection

Now that you have started to request and receive information about your prospective vendors, it is time to select the best ones based on the criteria mentioned above. You should select no more than two or three at most of these vendors and start further actions.

Step 5: meetings with final candidates

The meeting is an opportunity to determine the language service provider’s skills, expertise, and capabilities. The meeting can be done in person or via video conference. It is important to ask questions about the language service provider’s experience with clinical study translation, their knowledge of the medical terminology, and their ability to work with your team.

It is also important to find out if the language service provider has sufficient resources to handle your project. If you are not satisfied with any of the responses that you receive during the meeting then it is best not to proceed further in order for you not waste time on something that will not work for your needs.

Step 6: Signing the contract

If you are a pharmaceutical company looking for a language service provider to help you with the clinical study, it is important that you have a contract signed before the work starts. This contract will outline the terms and conditions of the agreement between your company and the vendor.

Before signing any contract, it is important to review it carefully. The contract should clearly state what services will be provided by the vendor as well as what tasks they will undertake. It should also specify how much they will charge for their services and how much you will pay them in return. The contract should include specific details about timelines for delivery, quality standards, and reporting requirements. The contract should also include all necessary legal disclaimers.

What is important when you work with a new vendor? How to manage the current translations? Tips for content preparation for the vendor. Manage TM and termbase.

And finally, when you signed the contract and begin to work, onboarding a new vendor is very important. This process includes a number of tasks, such as establishing a system of communication, the orientation of the vendor on what you need from them and how to do it, reporting back on progress on a regular basis.

Maybe you also need to take part in content management, and it will be beneficial for your vendor if it can consult you and help with this process.

Especially remember to prepare and maintain a TM (Translation Memory) and termbase for your project. They will help you save time and resources with consistency.

How to check quality? Importance of feedback. Why it is better to have few vendors to reduce the risks?

As quality is one of the important things you will need to monitor the quality of your new vendor. After all, you must be sure that contractors fully meet your localization and translation requirements for clinical trials. This could be done by well-known QA tools and spot check on your own, so you or your staff specialist should know the signs that translation is good or translation is bad. But the best choice will be using the third-party vendor for LQA purposes.
Thus if you have not just one but a few vendors you can:

  • Check the quality of each
  • Reduce the risk of failure if one of them will have problems with production and quality
  • Improve your translation process and quality in general

Setting up for a clinical trial translation process can be a challenging task, but once established, it has the potential to yield significant benefits. These benefits include speeding up the clinical trial process and obtaining quality results with fewer resources.

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