With clinical trial translations, you need more than accuracy.

Clinical trials are surrounded by a fast-paced and ever-changing set of challenges, from strict regulations to time constraints.

There is no room for costly mistakes or delayed projects — that’s why you must invest in the quality of your partners. By choosing CQ fluency, you can rest assured that all your translations will not only be accurate and compliant, but also culturally relevant, giving you a competitive edge in this industry.

We have perfected our ISO certified workflow to match your individual needs, giving you the flexibility that you need for each unique project.

When you request a project from us, we perform a cultural analysis early on. By integrating this aspect in the workflow, and because we always review the project for cultural red flags that could impact end use, you are guaranteed to get translations that go beyond accuracy and compliance: they are adapted to the culture of the country you are holding your clinical trial.

By working under the framework and governance of ISO 9001 and ISO 17100 certified quality management system, we ensure the consistent quality of the work we deliver.

We are all over the world

We are connected with over 1500 life sciences expert linguists worldwide. These in-country translators with scientific backgrounds ensure technical accuracy and consistency across all languages.

To mitigate risk, our linguists go through a very stringent qualification process and competency is routinely monitored.  They are knowledgeable of the clinical research field and work in compliance with Regulatory and Good Clinical Practice (GCP) guidelines. This way, we have culturally adapted content for:

  • Patients
  • Scientists
  • Healthcare professionals
  • Government agencies

Each one of these audiences is different, but equally important to reach. Having adapted translations for each one ensures optimal readability and the best engagement for your clinical trial.

This patient-centric approach is a trend that is encouraged and enforced by regulatory agencies. One of the important steps that we address and that set us apart from other translation companies is linguistic validation. Simply translating a document is not enough when we deal with clinical trial documents, because patients need meaningful and relevant translations, to perfectly convey the message of the original text. This approach increases treatment adherence and drives down re-admittance rates, improving the data you get from your trial.

We can handle all your Clinical Trial documents — and more

CQ Fluency has mastered the right mix of skill and cultural sensitivity to craft culturally adapted translations of all your clinical trial documents:

  • Case report forms
  • Clinical evaluations
  • Clinical protocols
  • Clinical study reports (CSRs)
  • Informed consent forms (ICFs)
  • Patient diaries/surveys

We can also provide multilingual call center support, which increases patient engagement and quality of care, while reducing costs by overcoming language barriers.

An important part of the Clinical Trials documents is about pharmacovigilance: the information about adverse drug reactions is crucial to patient safety. This is an area where translation plays an important role to make sure that pharmacovigilance and drug safety documents convey the same meaning in every language.

We use a 3-part framework to approach pharmacovigilance translations which includes understanding your specific requirements and support materials, identifying the four key elements of pharmacovigilance and executing our customized processes to consistently provide you with timely and accurate translations.

 

We are committed to your success

At CQ Fluency we like to be proactive and think ahead of our clients’ needs.

As regulations about clinical trials around the world get tighter and stricter, we have already adapted our processes and have a pool of expert life sciences linguists on hold, ready for the new challenges.

The Food and Drug Administration (FDA) regulations regarding clinical trials keep evolving and incorporating the laws passed by Congress. Some of the latest regulations are about Informed Consent and Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products, reflecting the emphasis placed on meeting the needs of trials participants and the trend toward having more transparency in clinical trial documents.

The Clinical Trials database is online for over a decade, and it “is the only publicly accessible source of results information for thousands of trials”, underlining its importance for the dissemination of knowledge and the importance of producing documents in a timely manner.

There are also changes in the way clinical trials are conducted: with the rise of new technology, trials will be increasingly digital and off-site, raising new challenges in the way that data is retrieved and how documents are produced.

As the clinical trials landscape evolve in the European Union, the Clinical Trial Regulation EU No. 536/2014 places a clear emphasis in having “the highest standards of safety for participants and increased transparency of trial information”.

The safety and transparency of clinical trials in the EU will be grounded on the public availability of the information about the authorization, conduct and results of each clinical trial through the Clinical Trials Information System website, which is expected to go live soon.

According to the European Medicines Agency website:

Through the website, members of the public can access detailed information on all clinical trials conducted in the EU, in all official EU languages.

Your success is our goal. We focus on providing translations that go above and beyond technical accuracy, so you can get the best out of your clinical trial.

Contact us today and become culturally relevant.