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life sciences

life sciences

navigating the global pharmaceutical landscape with expertise

At CQ fluency, we provide essential support to the life sciences industry and academic sponsors in their global clinical research endeavors. Our expertise spans all phases of clinical trial management, including patient recruitment, cognitive debriefing, and specialized clinician reviews.

What sets us apart is our unwavering commitment to patient-centric processes and excellence. Leading clinical research organizations choose CQ fluency for our ability to engage clinical experts in translating even the rarest diseases into the most exotic dialects and locales. Our patient-centric approach ensures that your message resonates with your target audience. Our strong connections with regulatory experts and the scientific community make us your ideal partner for translations and cultural adaptations.

CQ fluency delivers unparalleled medical and technical accuracy, supported by subscriptions to essential templates and glossaries of standard medical terminology. We access resources such as the European Directorate for the Quality of Medicines (EDQM) database and the Medical Dictionary for Regulatory Activities (MedDRA) to ensure precision in translating pharmaceutical materials.

Our formula for targeted life sciences communication

life sciences expert linguists worldwide

1,500 life sciences expert linguists worldwide

handle the assignments

Ability to handle even the most demanding assignments

Adherence your timetable and budget

Strict adherence to your timetable and budget

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

clinical validation

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

pharmacovigilance

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

labeling/e-labeling

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)

medical devices

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

training/eLearning

Recruit and retain global talent through culturally relevant communication and eLearning opportunities.

  • multimedia localization
  • multilingual eLearning
  • intranet/web localization
  • interpretation

regulatory submissions

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

multicultural marketing

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.

2

ISO 9001:2015 Certified

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.

ISO 17100:2015 Certified

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.

  • licensing
  • translatability assessment
  • linguistic validation (COA/eCOA)
  • full eCOA migration process
  • readability and usability testing
  • patient recruitment and retention
  • ISPOR-compliant cognitive briefing

pharmaceutical communications

Supporting global players in the pharmaceutical industry takes the right mix of skill and cultural sensitivity.

CQ fluency has mastered this. We carefully craft effective pharmaceutical communications ensuring the results are:

  • Understandable to the average consumer – regardless of cultural background
  • Informative to the medical profession in diverse markets
  • Medically and technically accurate
  • Compliant with a continually evolving regulatory landscape

explore our life sciences solutions

clinical trials translations

Our linguists and subject matter experts undergo 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.

  • clinical protocols
  • patient diaries/surveys
  • informed consent forms (ICFs)
  • case report forms
  • clinical evaluations
  • clinical study reports (CSRs)

linguistic validation

ISPOR-compliant processes ensure all components are conceptually equivalent across multiple languages & therapeutic areas

  • clinical outcome assessments (COAs)
  • electronic clinical outcome assessments (eCOAs)
  • quality of life (QOL) questionnaires

pharmacovigilance

SME resources and automated processes for speed and agility in pharmacovigilance and adjudication

  • AEs
  • SAEs
  • Medical charts, records
  • Patient records
  • SUSARs

regulatory submissions

ISO-certified quality control processes to ensure accuracy and compliance with EMA, EDQM and MedDRA

  • dosage formulations
  • FDA applications
  • pharmacological tests,
  • regulatory submission
  • prescribing information (PI)
  • package inserts/labeling

medical devices

We are a leading language compliance partner with an accredited team of medical translators experienced with regulations, such as EU MDR and IVDR.

  • IFUs (instructions for use)
  • medical device operation manuals
  • product catalogs
  • medical device software localization

medical information writing

Global multilingual content with a consistent scientific narrative. We support the full linguistic scope of medical information writing. Broad global network of subject matter expert clinicians in all therapeutic areas for all locales, including:

  • global content strategy
  • research and analytics
  • authoring, editing, translating
  • SME advisory support

We ensure your global master is translatable & fully inclusive of the diverse audiences you are trying to reach, with continuous refinement and testing of your narrative for high science or low science approaches.

corporate, global human resources & marketing

corporate

support your expanding global footprint through effective and engaging multilingual, intra-corporate content.

global human resources

recruit and retain global talent through culturally relevant communication and e-learning opportunities

marketing

cultural insights to ensure your global master is translatable & fully inclusive of the diverse markets you are trying to reach

clinician review

Broad global network of subject matter expert clinicians in all therapeutic areas for all locales. Optimization of clinical documentation to ensure it is appropriate for patients, resonates with the audience and compliant for the market, including:

  • cultural consulting
  • content optimization of clinical documentation
  • patient diaries/surveys
  • assessments and conclusions
  • clinical review templates
  • informed consent forms (ICFs)
  • case report forms
  • clinical evaluations
  • clinical study reports (CSRs)

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!

Play

pharmacovigilance/
drug safety

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

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.

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.

delivering accurate language services across all life science verticals

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chat about next life sciences project

let’s chat about your next life sciences project