CQ fluency is trusted by the world’s leading life science organizations for their language solutions
What makes CQ fluency different is we have a deep understanding of the life sciences industry while still taking the time to understand your specific challenges. Our nimble, collaborative culture allows us to apply experiences from across our customers to ensure we properly address your needs and avoid common pitfalls.
Processes focusing on the patient’s values, social/cultural environment and overall wellbeing, yielding more meaningful real world evidence to make reliable, informed decisions.
proactive patient recruitment
In-house resourcing is a constant activity helping us build relationships with real patients via patient associations and more.
cognitive debriefing with health research professionals
Resulting in stronger interview quality, stronger ability to relate to patients and stronger data/insights.
custom tech-enabled solutions
Our goal is to meet your goals. We are not selling technology, as we don’t believe in “one size fits all”, instead, we are leveraging the best/latest technologies on the market to customize our language solutions for your particular challenges and goals.
Processes ensuring we are not deviating far from the original concept, while still making a cultural connection and meet regulatory compliance. We display respect for cultural values, habits, formality to ensure content resonates. Our proprietary cultural checklist and multicultural experts examine the translated version for obvious and less obvious cultural nuances.
language solutions for life sciences translations
clinical trial management
Our longstanding connections with the scientific community, as well as our expertise, allow us to facilitate expert support in all facets of clinical trial management.
- ISO-certified quality control processes ensure accuracy and compliance with FDA, EMA, PMDA and MHLW, CTR, etc.
- COA copyright and licensing support
- creation of financial projections for COA
- deep collaboration with sponsors and copyright holders
Our ISPOR and ISOQOL-compliant processes ensure all components are conceptually equivalent across multiple languages and therapeutic areas.
- ISPOR and ISOQOL-compliant linguistic validation processes
- (electronic) clinical outcome assessments (eCOAs) migration solutions
- unique pilot-testing and interview techniques
- readability and usability testing
- quality of life questionnaires
We offer subject matter expert resources and automated processes for speed and agility for pharmacovigilance translations.
- adverse events (AEs/SAE/SUSARs)
- medical charts
- patient records
- development of patient education materials to support a Risk Management Plan
- scientific articles from global medical journals for regulatory submissions
Our stringent ISO-certified quality control processes for the translation of highly technical and regulated medical labeling.
- in-depth expertise in wide spectrum of relevant therapeutic and technical areas
- study drug label creation
- global regulatory label reviews
- validated labeling terminology repository
- package labels (PILs)
As a language compliance partner, we have an accredited team of medical translators familiar in local, regional and national regulations, such as EU MDR & IVDR.
- Instructions for Use (IFU) localization
- operation and installation manuals
- device apps and software testing and localization
- medical writing for lay and professional audiences
- readability and usability testing
Recruit and retain global talent through culturally relevant communication and eLearning opportunities.
- multimedia localization
- multilingual eLearning
- intranet/web localization
ISO-certified quality control processes to ensure accuracy and compliance with EMA, EDQM and MedDRA.
- dosage formulations
- FDA applications
- pharmacological tests
- prescribing information (PI)
- package inserts/labeling
Cultural insights to ensure your global master is translatable & fully inclusive of the diverse markets you are trying to reach.
- web/app localization
- advertising, brochures, fact sheets, posters
- multicultural consulting
- cultural hypertargeting
Our ISO-certified multistep translation process is our foundation
At CQ fluency, we customize your life sciences translation process with our ISO-certified workflow procedures. They are fully compliant with the ISPOR Principles of Good Practice for Translation and Cultural Adaptation of PROs and ISOQOL guidelines.
We have implemented a Quality Management System in accordance with ISO 9001:2015. This certification demonstrates our ability to consistently provide products and services that meet customer and regulatory requirements. We also aim to enhance customer satisfaction through effective processes.
We have implemented a management system in compliance with ISO 17100:2015. This certification demonstrates that our core processes and resources meet the needs for a quality translation service.
language essentials for COA/eCOA
At CQ fluency, we are your partner in every stage of clinical trial development and execution and believe that your multilingual COAs ultimately help you make more informed decisions to improve patient care around the world. Our strategic partner, founded in 1987, specializing in ePRO, created the first Standard Operating Procedures for translation and linguistic validation of quality-of-life instruments in 1992. These same standards are the foundation of the ISPOR Guidelines that remain the industry’s quality standard today.
Together with our COA and licensing partners, CQ fluency engages in over 60 multilingual clinical studies and conducts an average of 60,000+ patient interviews annually. CQ fluency acts as the main point of contact between license holder and trial sponsor.
- contacting COA developers to determine all licensing requirements
- creating financial projections for the licensing and expert validation
- obtaining existing COA translations and certifications, advising on language quality of scales
- corresponding with COA developers to define requirements for new translations
- ensuring compliance in eCOA form
We identify components of instruments that are difficult to translate or require significant cross-cultural adaptation.
- leveraging ISOQOL SIG (Special Interest Group) TA methodology, we report on the severity of translation difficulty
- using CQ fluency’s proprietary process, our team of SME linguists advise on source text revision
linguistic validation (COA/eCOA)
We regularly monitor the evolving regulatory landscape (FDA PRO Guidance, EMA guidelines, and ISPOR Good Practice) to ensure translations are conceptually equivalent and culturally appropriate. CQ fluency’s validation reports & certification includes details on patient recruitment, interview data analysis and recommendations. We are in full compliance with ISPOR/ISOQOL requirements, including but not limited to COA steps completed, qualification of interviewers, inclusion criteria, verification of screenshot review, etc.
After the forward / back translations and reconciliations are complete, we apply our unique cognitive debriefing process to recruit patients as well as HCPs with proven interviewing skills. We itemize our interview questions to prevent cognitive fatigue of the patient. We specialize in difficult to recruit indications with an extensive scientific network to access the right organizations.
- in countries with ethical approval procedures for access to patients in clinical settings, we recruit via patient associations and support groups
- in countries without an ethical approval framework, we recruit directly from clinicians
- for a low incidence population or a population with severe disease burden, recruitment may be unfeasible. In these cases, we recommend alternative populations with similar symptomatology.
full eCOA migration process
We introduce a short usability section at the beginning of the interview, where we video record participants completing the eCOA electronically, using techniques commonly used in usability testing (e.g., of wearable devices, patient diary apps, etc.) and follow up with simple questioning designed to elicit responses for qualitative analysis (Talk/Think aloud Protocol).
CQ fluency manages the full migration process of hard-copy content to a digital environment, including:
- analyzing the hardcopy QoL source and target to determine migration challenges
- migrating of the existing QoL translations in .xml or .json files
- preparing for a screenshot review, offline or online in the app
- coordinating and implementing developer review in final localized platform
- performing readability and usability testing
passing readability and usability testing in any language
At CQ fluency, we are fluent in over 200 languages, and we work with over 2,500 certified in-country linguists. Translating medical device information can be a lengthy process, requiring all relevant instructions, guidelines, dosages, contraindications, etc., to be adapted and effectively tested for the localized market. Our experts have both cultural and subject matter expertise, ensuring your IFUs exceed your expectations in any language.
patient recruitment and retention
CQ fluency is very proactive when it comes to recruiting and onboarding health research professions as interviewers for cognitive debriefing. They demonstrate better interview techniques, because of their unique and culturally appropriate approach to probe for more information, leading to more meaningful data for the developers. In parallel, we believe that resourcing is a constant activity. We build up, train our own dedicated expert teams, and remain persistent in hiring the best qualified people from professional research background. Resourcing is an activity we do all the time, not just in the sphere of linguistic validation, but also for regulatory affairs, medical writing, readability and usability testing.
In parallel, we continuously work on patient recruitment that provides us with full in-house control and view of the best organizations/consultants to partner with. We source and onboard them ourselves. We do not retain patient data for ethical reasons, but we do hold details and build partnerships with the credible clinics and patient associations. We work hard to ensure a true patient representation of the population in all its diversity based on who is going to use that particular drug or device.
ISPOR-compliant cognitive briefing
At CQ fluency, we take pride in our cognitive debriefing processes to test instruments and questionnaires among patient populations that are truly representative of the target population. We are well versed in the regulations to deliver exceptional accuracy and cultural relevance from start to finish.
For patient and other reported outcome questionnaires that are used as primary endpoints in clinical trials, we have a unique approach to the linguistic validation and cognitive debriefing process that focuses on minimizing patient distress during the interview while still obtaining meaningful data-driven results for the sponsor. Our COA research methodology for linguistic validation and cognitive debriefing fully complies with ISPOR recommended methodology and corresponds to FDA and EMA guidelines for using Patient Reported Outcome (PRO) instruments from international clinical trials.
network of clinician reviewers
CQ fluency is a well respected translation supplier in the scientific community. We have handpicked the best clinicians in all geographies. Many times startups and smaller companies don’t have the funding for an extensive linguistic validation project. In many cases, our clinician reviews help them face budgetary constraints while meeting regulatory needs and deadlines.
We pay attention to how we supply medical content to our clinicians. Our unique and user-friendly IPS (Item Processing Step) breaks down each text segment and is a proven method to motivate the subject matter expert to pay more attention to the text. Our clinicians compliment us on how the content is broken down and we make ourselves available for queries and feedback.
In-Country Review (ICR) processes
Clearly outlining the objectives and process of an In-Country Review (ICR) is how CQ fluency is able to ensure your team is validating our translation work in the most efficient way possible. We are cognizant of the busy agendas of your reviewer staff and organize the ICR process to accommodate the most efficient use of your reviewers, specifically input on company-specific terminology in their respective language/region.
This includes clarifying the specifications of your therapies and collaborating on regulatory requirements. Our ultimate goal is to ensure we are working as a close-knit team with your reviewers for high-quality translations that meet your deadlines. CQ fluency will provide training and specific guidelines that will facilitate this review that can be provided online or offline. If you do not have subject matter expert staff locally for the ICR, CQ fluency can engage hand-picked medical experts with experience in particular subject matters to provide the ICR on behalf of the client.
strict quality controls for accurate clinical labels
Watch our vice president, life sciences, Clio Schils, address the Translating Europe Forum with a compelling story and inspiring discussion on why it’s essential for healthcare translation services to embrace the importance of cultural adaptation in clinical labeling.
(Translating Europe Forum 2019)
Connect with Clio for more multicultural insights for life science translations!
CQ fluency is committed to patient safety with swift pharmacovigilance translations. Our formula for success includes continuously optimizing our resources, processes and tools for pharmacovigilance. Our full suite of pharmacovigilance solutions include:
drug safety library
- repository of publicly available medical articles from around the globe that have been translated
drug safety mining
- our growing list of classified keywords help identify adverse events
- our text mining platform can be used for a variety of data sources, including medical literature, electronic health records, online user-generated content and notification processes
drug safety automation
- request goes directly to qualified linguists that have been trained on AEs/SAEs
drug safety interpretation
- on-demand services for call center support
real results >>
rapidly translate flagged medical literature and adverse events to meet regulatory deadlines
Read our case study that explains how we helped one of the world’s largest pharmaceutical companies scan, flag and quickly translate life-threatening AEs and SAEs in medical literature in 23+ languages and reduce turnaround by 50% without compromising quality.
social mining for drug adverse events linguistic & cultural considerations
Social media can also be an important source of information for real-time reporting of adverse events in scenarios such as the Covid-19 pandemic. Early in 2021 as Covid-19 as more people received vaccines, women began to use social media to report changes in their menstrual cycles, correlating the changes to their vaccinations. This eventually piqued the interest of two scientists with expertise in menstrual cycle changes and they set up a study to officially document the changes, which had 40,000 respondents as of August 2021.
regulatory compliance and risk management
The continuously evolving regulations in pharmaceutical, biotech, clinical research and medical device industries require expertise to ensure you are meeting the linguistic requirements for each country/region. New regulations almost always mean a heavier volume of content to handle. Partner with CQ fluency to continuously plan how to address language compliance.
Relevant publications include:
- Navigating the evolving regulatory requirements of the Clinical Trials Regulation (EU) No 536/2014 requires re-aligning human capital, technologies, and processes to ensure overall compliance. Read more>>
- The new Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) put a strong emphasis on monitoring the devices – not only at time of launch, like the old directive – but during the whole life-cycle of the device, calling for additional regulatory documents and specialized translations. Read more>>
medical device translations
(MDR and IVDR)
We understand that you are solving some of the world’s biggest healthcare issues through technology and need a global communication partner who can help you meet the needs of a wide array of end users — health care providers, scientists, patients and more. With over a decade experience in this area, CQ fluency is well versed in complying with global and local government regulations while also addressing cultural nuances to truly connect with the intended audience in your target markets.
CQ fluency’s translation experience includes but is not limited to IFUs (Instructions for Use), medical device operation manuals, product catalogs, brochures, web content, and localization of medical device software. Our diverse team includes over 1,500+ certified medical translators and editors, many with MD qualifications and advanced biomedical and/or engineering degrees. We have a thorough understanding of medical device regulations and are prepared to be your language compliance partner with the EU MDR and IVDR regulations.
custom tech-enabled solutions
The right language technology for any organization is never a “one-size-fits-all” solution.
CQ fluency combines human expertise with customized tech-enabled solutions to continuously optimize translation efficiency. Optimizing human involvement in your innovations, automations and connections is where your language service provider can add the most value.
Our customers will tell you that our nimble responsiveness is what makes us different from other language service providers. You can depend on CQ fluency to be creative, deliver on time, meet your quality requirements and scale to your needs.
The CQportal is a free, secure, cloud-based SSO-enabled portal that provides you with the ability to submit project requests 24/7 and view project status with advanced reporting capabilities.
This tool allows you to maximize productivity through customized connections/integrations to your platforms as well as integration into a centralized Translation Memory (TM). The CQportal also increases transparency and security with flexible rights management capabilities and encrypted data transfer to ensure security of sensitive data. The CQportal also simplifies production by reducing repetitive tasks with automated workflows and automated communication functionality.
CQmemory (translation memory management)
CQ fluency is highly experienced in managing centralized multi-vendor Translation Memories for large enterprises that incorporate glossaries and QA tools. We pride ourselves in continuously training our teams to implement TM maintenance best practices for TM effectiveness. This includes leveraging our file prep checklist, customizing filter settings, enhancing export/import tools, flagging suboptimal translations and updating TMs immediately upon the completion of any translation project . This give us to the ability to “split” documents amongst multiple translators with access to the same TM and glossary assets (real-time). Our proprietary filters lock down specific content to avoid inconsistencies across multiple similar documents. Overall, we help reduce spend and providing consistency with your brand voice.
Our Artificial Intelligence platform provides a customized cultural engine for content analysis, powerful insights and the ability to drive scale.
With our growing list of classified keywords that help identify adverse events, our text mining platform can be used for a variety of data sources, including medical literature, electronic health records, and online user-generated content.
The CQmigration solution streamlines eCOA migration and mines for/flags differences between paper COA version and eCOA versions. This ensures that the adaptations are made consistently across all languages in the trial to ensure data integrity. Our adaptable CQ QA tools feature configurable settings based on materials (including custom filters that can maintain code elements).
CQ fluency’s MSP has a proven track record of aggregating translation suppliers worldwide under one unified system to optimize translation workflows, centralize Translation Memories and empower requestors to obtain standardized, competitive quotes from multiple language service providers. Established in 2018, this effective program includes the change management, training, support and guidance needed to quickly demonstrate better quality, faster translations, consistency across providers and cost savings.
CQ automation reduces human touch points of manual processes, improves the intake process, optimizes workflows to expand production capacity/scalability and implements an automated billing process right for your team.
why CQ fluency
CQ fluency helps life sciences industries and academic sponsors with their translations for clinical research studies around the world, and for all phases of clinical trial management operations.
We are on a mission to improve lives by having a positive impact in every life we touch. Our culturally relevant translations go beyond compliance by removing language barriers to drive health equity and improve health outcomes.
culturally relevant language solutions for today’s diverse communities
at CQ fluency, we’re not just translation experts, we’re culture experts
Culture is the human component to the words we speak . . . influencing their use, structure and providing context. A literal translation or simply translating word-for-word will NOT preserve the intended meaning of your message. Our Cultural Intelligence (CQ) blends both meaning and feeling to create effective communications that transcend words and engage hearts and minds, facilitating true human connections in any language.
proud to serve
FDA guidance pushes for increased diversity in clinical trials
In April 2022, the FDA published new guidance that impacts companies developing human drugs and medical devices asking these companies to outline how they plan to diversify their clinical trial participation with ways to increase the number of Black, Hispanic, Native American, Asian or other persons of color in clinical trials.
The plan should describe how they are inclusive of diverse ethnicities and races to ensure the data collected is clinically relevant by including underrepresented populations from underserved communities. Consistent representation across different demographics, ethnicities and races provide opportunities to support early access to medical discoveries, improve the understanding of disease or use of medical devices and inform the safe and effective use for all types of patients.
Addressing Health Disparities Through Diversity in Clinical Trials
Are you considering how interventions, educational programs, and marketing plans are communicated to diverse populations with respect to their cultural norms and where English is not the primary language?
Cultural intelligence refers to fostering cross-cultural communication, which can involve the recognition of common behaviors. Beyond the visual cues (dress, festivals, foods, and language) that define a patient population, there are “hidden” attributes (beliefs, manners, biases, beauty ideals, et.al.) that build rich and diverse heritages. For example, Asian cultures are known more for collectivism, while Western countries tend to emphasize individualism. Therefore, in Asian cultures, oftentimes family is involved in the decision making for healthcare and need to be part of your communication plan.