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Translation & Linguistic Validation Services PATIENT FOCUSED, QUALITY DRIVEN As pioneers in the field of translation and linguistic validation of health outcome measures, we uphold our reputation for high quality work, attention to detail, and excellent customer service on every project. Services We Offer: Clinical Outcome Assessments (COA) Translation Most outcomes measures have been developed and validated in English. In order to ensure that data collected in multinational clinical trials can be pooled for analysis and ultimately submitted for a label claim, translated versions of COA's must be as conceptually and culturally equivalent as possible. To achieve this equivalence, a rigorous translation methodology with attendant focus on quality and cultural appropriateness is imperative. Through our industry-wide recognized translation approach, we deliver on the promise that our translations are linguistically and culturally appropriate for each target population, and that patients across the globe understand translated items as intended by the English source instrument. Linguistic Validation Patients live with their disease, treatment or conditions. As such, patients themselves provide the most informative, useful perspective on a questionnaire's (COA’s) content. FACITtrans’ full COA translation methodology specifically requires interviewing patients with the translated questionnaire and asking them questions about the items in order to fully capture the target-language patient’s voice and experience. This process, called “cognitive interviewing”, helps ensure the final translated versions are as conceptually and culturally equivalent as possible. These steps seek to affirm the linguistic validity of the translated measure and ultimately strengthen our clients’ ability to understand the multinational patient perspective and obtain a label claim from internationally-collected clinical trial data. At FACITtrans, we believe capturing the patient voice is imperative. As highlighted on our History page, our team was part of the original publication of these now widely-accepted translation approaches. For over 20 years our mission has been Providing A Voice for Patients Worldwide. We deliver on this promise to patients and our clients every day. eCOA Translation, Adaptation, Migration and Screenshot Proofreading Electronic Clinical Outcome Assessment (eCOA) is a way of capturing data electronically in clinical trials. Many measures were developed for paper administration. When adapted for electronic assessment, often there must be some adjustments to the measure’s instructions or layout. FACITtrans’ eCOA expertise includes: Adapted over 90% of FACIT scales into as many as 70 languages Adapted over 15 non-FACIT instruments into as many as 30 languages Currently supporting >15 pharma clients & eCOA vendors FACITtrans provides these services: Instruction adaptation for clear patient comprehension Adapt language to fit context of device Multilingual migration to XML, JSON and CSV formats Screenshot proofing across variety of electronic platforms Learn about FACTtrans’ expertise with eCOA’s Interview Transcription & Translation Conducting interviews in other countries, but need transcripts of the interview in English? We have years of experience transcribing interviews, and translating the interviews into English for you. Quality checks are scheduled at each step of the process. Translation of Consent forms, Diaries, Event Logs and Protocols As longtime members of an academic research community (it's where we got our start!) we are well versed in the administrative and legal requirements of clinical trial research. Standardized documentation such as diaries, event logs, or legal/administrative documentation like consent forms or protocols require simpler translation methods but with rigorous quality and semantic monitoring. Translatability Assessment and Concept Definition COA measures are most-often developed in English, and certain concepts may not translate easily or prove to have limited or no conceptual equivalence in other cultures. Translatability Assessment refers to the proactive process of identifying such issues as early in the instrument development process as possible. Concept definition, also referred to as concept elaboration, goes hand in hand with this process and serves to define terminology and intended meaning of items providing acceptable translation alternatives, unacceptable translation alternatives, and offering solutions for specific translation issues within linguistic families. Engagement with instrument developers is crucial at these key stages to ensure the intended meaning of each item is conveyed to produce translated items that say what they mean and mean what they say. FACITtrans Services eCOA We look forward to serving your study needs. Learn more and Contact us to get started! FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

FACITtrans is much more than a translation company. We are an experienced health outcomes group trained in rigorous scientific principles, grounded in robust quality control systems, ISO 9001:2015 certified, and committed to low administrative burden for our clients and vendors. FACITtrans Expertise ACADEMICALLY TRAINED, SCIENTIFICALLY RIGOROUS FACITtrans is much more than a translation company. We are an experienced health outcomes group trained in rigorous scientific principles, grounded in robust quality control systems, ISO 9001:2015 certified, and committed to low administrative burden for our clients and vendors. Small, but mighty, industry powerhouse We have translated and linguistically validated over 100 FACIT measures into over 80 universal language versions, focusing on a wide range of disease areas such as cancer, HIV/AIDS, multiple sclerosis, and general chronic illness. We have translated hundreds of non-FACIT measures into even more languages than those present in the FACIT Measurement System. Principal translation resource for NIH initiatives In addition to our work with the pharmaceutical industry, we serve as the principal resource for translating the item banks in each of the following National Institutes of Health projects (among others): PROMIS (Patient Reported Outcomes Measurement Information System) (U01 AR 052177) NeuroQOL (HHSN 2652004236) NIH Toolbox (AG-260-06-01) We look forward to serving your study needs. Contact us to get started! In 25+ years of providing PRO translations, we have cognitively debriefed more than 10,000 patients internationally. A voice for patients worldwide, for over 25 years Integrated expertise Our translations are grounded in state-of-the-art outcomes measurement science. Because our roots are deep in COA assessments, the translations thereof are not just a business but part of a contiguous research program, which includes all phases of COA development, assessment, measurement and clinical trial consultation. Services Quality in and across projects, no rework. LEARN MORE Label Claims Our translations in label claims. LEARN MORE Publications Active contributors in the fields of translation and COAs. LEARN MORE Affiliations Sponsor and contributor for 25+ years, ISOQOL, ISPOR, ATA, and more. LEARN MORE FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

Our passion for linguistics is what drives us. FACITtrans Publications OUR PASSION FOR LINGUISTICS IS WHAT DRIVES US Below are selected publications and presentations by our staff, detailing the various approaches and challenges to attaining cross-cultural measurement equivalence. PublicationsTop Your search returned 0 results Ensuring relevance and equity in patient reported outcomes (PROs) in endometrial cancer: The SGO promote study (Patient Reported Outcomes Measurement Opportunities Through Equity) Wenzel L., McKinney C., Jensen S., Peipert D., Ganatra S., Bredle J., Sisodia R., Doll K., Philp L., Arend R., Dholakia J., Cella D. Gynecologic Oncology Volume 194, March 2025, pp. 137-144 https://doi.org/10.1016/j.ygyno.2025.02.020 Principles of good practice for translation of electronic clinical outcome assessments Shalhoub, H., Turner, M., Bradley-Gilbride, A., Eremenco, S., Muehlan, H., Parks-Vernizzi, E., Arnold, B., Kulis, D., Anfray, C., Chaplin, J.E., Repo, J.P. J Patient Rep Outcomes 9, 26. https://doi.org/10.1186/s41687-025-00859-4 Translatability Assessment of the Fluid Overload from Nephrotic Syndrome Measure Pérez, B., Carlozzi, N., Arnold, B., Parks-Vernizzi, E., Herzberg, T., Peipert, J.D., Creguer, T., Hurt, C., Lai, J., Raghunathan, T., Ganatra, S., Hashemi, S., Scherr, B., Zhai, Y., Salmon, E. Quality of Life Research (2024) 33:S1–S235 Presented at ISOQOL Cologne, October 2024. Translation and linguistic validation of 24 PROMIS item banks into French Ahmed S, Parks-Vernizzi E, Perez B, Arnold B, Boucher A, Hossenbaccus M, Correia H, Bartlett SJ. Qual Life Res. 2024 Aug;33(8):2119-2127 . doi: 10.1007/s11136-024-03690-4. Epub 2024 Jun 12. PMID: 38865068; PMCID: PMC11286690. Dealing with the Complexities of Concurrently Translating and Implementing Electronic Clinical Outcome Assessments: Best Practices Roundtable: The Two-Step Dance of Concurrent Translation and Implementation of eCOAs Shalhoub, H., Turner, M., Bradley-Gilbride, A., Eremenco, S., Muhlan-Rehmer, H., Parks-Vernizzi, E., Arnold, B., Kulis, D., Anfray, C., Chaplin, J. Quality of Life Research (2024) 33:S1–S235 Presented at ISOQOL Cologne, October 2024. Translation and Linguistic Validation of the EXACT for Use with COPD Patients in African Countries Savic L., Arnold B., Baily A., Mackey DJ., Olaiya P. Presented at ISOQOL Calgary, October 2023. Winner of the 2023 Outstanding Poster Award Psychometric properties of the Polish version of the FACIT-Sp-12: Assessing spiritual well-being among patients with chronic diseases Machul M., Bredle J., Jurek K., Dobrowolska B. Med Sci Monit. 2023 Nov 16;29:e941769 Achieving Conceptual and Cultural Equivalence in Universal Arabic PROMIS Item Banks Parks-Vernizzi E., Nagy E., Guillen R., Boucher A., Arnold B., Maksud E., Correia H., Bakhsh HR, Bin Sheeha BH, Al-Dhahi M., Al-Hasani R. Presented at ISOQOL Calgary, October 2023. Translation & Linguistic Validation of the FACIT-COST Measuring Financial Toxicity in Cancer Patients Worldwide Savic L., Parks-Vernizzi E., Arnold B., Bredle JM Presented at ISOQOL Calgary, October 2023. Translation & Linguistic Validation of PROMIS SF v2.0 -Physical Function -MS 15a & PROMIS SF v1.0 -Fatigue -MS 8a for use in India & Malaysia Parks-Vernizzi E., Pérez B., Maksud E., Son J., Arnold B., Correia C. Presented at PHO Prague, October 2022. Prev 1 2 3 ... 11 1 ... 1 2 3 4 5 6 7 8 9 10 11 ... 11 Next We look forward to serving your study needs. Contact us to get started! FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

Over 25 years of methodologically rigorous COA translations. FACITtrans History V2 OVER 25 YEARS OF METHODOLOGICALLY RIGOROUS COA TRANSLATIONS Today 2024 2023 2022 2021 ISO 2021 2020 ISO 2017 2016 2012 2009 2005 2004 2001 1996 1994 Today 2024 Today Title? Quality and processes are our strength, flexible, creative solutions our calling card. While most of our work is for top pharmaceutical companies, we regularly partner with Dr. Cella’s research program at Northwestern University - the largest academically based outcomes research group in the world. We contribute to a number of large-scale consortium initiatives such as PROMIS and PROTEUS, and with industry leaders like Critical Path Institute PRO Consortium . 2023 2024 Title? Expand vendor management activities to meet demand and reinforce our global reach throughout Africa, India, LATAM, US, and Europe for translation, embedded interviews and more. 2022 2023 Savic L., Arnold B., Baily A., Mackey DJ., Olaiya P. Translation and Linguistic Validation of the EXACT for Use with COPD Patients in African Countries. Presented at ISOQOL Calgary, October 2023. ISOQOL poster of the year Embedded Interviews (qualitative interviews with patients in their native language that take place in the context of a clinical trial) become a fixed part of our growing service offerings. Not only do we carry out the interviews, but we transcribe and translate them. Clients love our openness to new areas and our constant eye on quality and processes in any area we enter. 2022 Title? 2021 2022 Begin expanding our Europe team to meet language services demand. 2021 C-Path selects FACITtrans as their preferred translation vendor. 2020 2021-2023 Title? Our Executive Director, Emily Parks-Vernizzi, served as ISOQOL’s TCA-SIG Co-Chair and is currently a member of the TCA-SIG Steering Committee and the Digital Health and eCOA SIG ISO 2021 I SO 2021 FACITtrans earns ISO 17100:2015 certification Building from our ISO 9001:2015 certification, we placed our translation and processes under additional scrutiny to earn our ISO 17100:2015 certification, further reinforcing our commitment to the patients’ voice through our high-quality COA translation and linguistic validation. We are proud to receive significant auditor praise for our processes at every surveillance and recertification. 2020 Title? Our president, Benjamin Arnold, co-authors JPRO paper of the year “Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures”. Soon after publication, the FDA references this paper in their guidance to help clinical trial sponsors select, use, and optimize clinical outcome assessments (COAs) in their trials. McKown S, Acquadro C, Anfray C, Arnold B, Eremenco S, Giroudet C, Martin M, Weiss D. Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures. J Patient Rep Outcomes 4, 89 (2020). https://doi.org/10.1186/s41687-020-00248-z ISO 2017 I SO 2017 FACITtrans earns ISO 9001:2015 certification Quality processes have always been central to our work, which is why our group co-authored the 2005 ISPOR translations guidelines. Our ISO 9001:2015 certification in quality management underscores our commitment to our clients and research collaborators. 2016 2012 2016-2018 Title? Our President, Benjamin Arnold, served as ISOQOL’s Translation and Cross-Cultural Adaptation - Special Interest Group (TCA-SIG) Co-Chair, and is currently a member of the TCA-SIG Steering Committee. 2009 2012 Title? Forerunners of eCOA adaptation/localization for the FACIT Measurement System and other COA measures known for our expert knowledge and flexibility. Beginning of our close ties with leading eCOA providers. 2005 2009 FACITtrans is born. The translation and formatting team formerly part of CORE becomes FACITtrans, a boutique language service provider under the scientific direction of Dr. Cella, with close connections to the outcomes scientists at Northwestern’s Department of Medical Social Sciences. 2004 2005 Title? Our translation group co-authors the landmark ISPOR translation and cultural adaptation guidelines that are now accepted as industry standard. Wild D, Grove A, Martin M, et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005;8(2):94-104. 2001 2004 Title? First-ever PROMIS translations into Spanish, and author the definitive concept definitions for PROMIS. Arnold B., Correia H., Cella D. Translation of the Patient Reported Outcomes Measurement Information System into Spanish. Poster presentation at the 14th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Orlando, FL, 2009. 1996 2001 The translation group publishes an article, and causes a stir. The translation group publishes the first-ever article to promote the universal approach to COA translation, which 20 years later is still considered methodologically novel. Eremenco S., Arnold B., Cella D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions 2005; 28(2): 212-232. 1994 Bonomi, A.E., Cella, D.D., Hahn, E.A., Bjordal, K., Sperner, B., Gangeri, L., Bergman, B., Willems, J., Hanquet, P., & Zittoun, R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Quality of Life Research 1996; 5: 309-320. 1996 The FACIT Translation Methdology is official. 1994 Clinicians request the FACT-G in Spanish, our translation group is born, with equivalence and quality at the forefront of our work. Meet the Team Benjamin Arnold, MA President Emily Parks-Vernizzi, MBA Executive Director MEET THE WHOLE TEAM FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

Over 25 years of improving patient health status measurement. FACIT.org History OVER 25 YEARS OF IMPROVING PATIENT HEALTH STATUS MEASUREMENT 1990’s 1997 Late 90’s Mid-2000’s 2018 2019 2021 2023 2025 TODAY 1980’s FACIT.org is the licensing entity for the well-known FACIT measurement system. Because of its strong development and validation processes plus its exceptional measurement characteristics, the FACIT System is widely used in clinical and academic research, as well as in clinical trials to capture the patient's perspective of their disease, treatment or condition. 1980s 1980’s The patient's perspective in focus Renowned health outcomes researcher David Cella, Ph.D., develops the Functional Assessment of Cancer Therapy (FACT) questionnaire while completing his post-doctoral studies at Memorial Sloan Cancer Center in New York. (Cella et al, 1993) The results of his work formed the cornerstone of the Functional Assessment of Chronic Illness Therapy, a compilation of over 100 distinct self-report questionnaires that assess a wide variety of symptoms, functional abilities, general perceptions of health and well-being, and other aspects of health-related quality of life. Some of these questionnaires are disease-specific (e.g., cancer, multiple sclerosis, HIV disease), some are related to specific treatment-related toxicities (e.g., central or peripheral neurotoxicity, gastrointestinal toxicity), some are symptom focused (e.g., pain, fatigue), others address physical, mental and social function, and still others assess mood and well-being. All were developed and created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages in which each item has been translated. Cella D.F., Tulsky D.S., Gray G., Sarafian B., Lloyd S., Linn E., Bonomi A., Silberman M., Yellen S.B., Winicour P., Brannon J., Eckberg K., Purl S., Blendowski C., Goodman M., Barnicle M., Stewart I., McHale M., Bonomi P., Kaplan E., Taylor S., Thomas C., Harris J. The Functional Assessment of Cancer Therapy (FACT) Scale: Development and validation of the general measure. Journal of Clinical Oncology 1993; 11(3): 570-579. 1990 1997 Late 90s Mid-2000s 2018 2019 2021 2023 2025 Today 1990’s The FACT goes global As globalization evolves, the demand for valid, translated versions of the FACT measures rises. The FACT Translation Project begins, and the FACT-G (General), FACT-B (Breast), FACT-Br (Brain), FACT-BMT (Bone Marrow Transplant), FACT-C (Colorectal), FACT-CNS (Central Nervous System), FACT-Cx (Cervical), FACT-E (Esophageal), FACT-H&N (Head & Neck), FACT-L (Lung), FACT-P (Prostate), FACT-O (Ovarian), and FAHI (HIV) become the first measures translated and linguistically validated into 7 languages following a newly-developed FACIT translation methodology ensuring equivalence across translations. Today, over 100 measures are available in over 80 languages. 1997 FACT becomes FACIT Functional Assessment of Chronic Illness Therapy (FACIT) is adopted as the formal name to reflect the FACT’s growth and evolution into a system that also includes content to measure diseases, treatments and conditions outside oncology. Late 90’s Item Response Theory and FACIT Advanced methods in statistical and psychometric approaches including item response theory (IRT) provide increasingly robust analytic methods permitting analysis on a per-item basis. Use of IRT to examine an item’s measurement characteristics gives investigators a way to lower patient response burden by only administering items most relevant to patients. Mid-2000’s Dr. Cella launches PROMIS The National Institute of Health supports this science via an initiative known as PROMIS (Patient Reported Outcomes Measurement Information System), in which Dr. Cella is the Principal Investigator of the Statistical Coordinating Center. A second federally-funded item-banking project specific to neurological conditions, Neuro-QOL, follows; Dr. Cella grants permission for FACIT items to be used in both these initiatives so that these FACIT items can be scored on a national metric. Dr. Cella remains a central resource to the PROMIS Health Organization to this day. 2018 FACIT Searchable Item Library In 2018, the FACIT Searchable Item Library is released. Users may now search FACIT’s 700+ items and develop a custom measure targeted to their specific patients using the Build-a-PRO function. 2019 C-Path PRO Consortium chooses FACIT.org The Critical Path Institute (C-Path) PRO Consortium chooses FACIT.org to manage licensing for patient reported outcome measures. It is our honor to use our knowledge-base and processes to support such a scientific leading organization. 2021 FACIT.org doubles staff FACIT.org doubles our staff to meet ongoing increases in licensing demands of not only FACIT- and C-Path measures but also other questionnaires which FACIT.org now manages. More and more clients trust their measures to our group. 2023 FACIT.org adapts internal infrastructure FACIT.org adapts internal infrastructure to more effectively deliver measures and related documentation (i.e. administration, translation certifications and watermarked versions). Clients praise our process as one of the most efficient in our sector. 2025 FACIT Group expands licensing expertise FACIT Group begins licensing coordination of other COA measures on behalf of clients’ trials, expanding our licensing expertise to help clients navigate the vast landscape of COA’s, developers and fees. Today Looking ahead FACIT continues to evolve with increasing focus on individual, targeted measurement, the use of Clinical Outcomes Assessments (COA’s) in routine clinical practice and development of new items and measures. Meet the Team David Cella, PhD President, Chief Scientific Officer Jason Bredle, MFA Director Shannon Romo Licensing and Financial Administrator MEET THE WHOLE TEAM

Over 25 years of methodologically rigorous COA translations. FACITtrans History OVER 25 YEARS OF METHODOLOGICALLY RIGOROUS COA TRANSLATIONS 1994 1996 2000 2001 2004 2005 2009 2012 2017 2021 1993 1993 1993 Patient perspective on effects of cancer treatment gain recognition As part of increasing interest from the international clinical and research communities to assess the patient's perspective of his or her disease, David Cella, Ph.D. publishes the original manuscript on his development of the Functional Assessment of Cancer Therapy FACT-G. Cella D.F., Tulsky D.S., Gray G., Sarafian B., Lloyd S., Linn E., Bonomi A., Silberman M., Yellen S.B., Winicour P., Brannon J., Eckberg K., Purl S., Blendowski C., Goodman M., Barnicle M., Stewart I., McHale M., Bonomi P., Kaplan E., Taylor S., Thomas C., Harris J. The Functional Assessment of Cancer Therapy (FACT) Scale: Development and validation of the general measure. Journal of Clinical Oncology 1993; 11(3): 570-579. 1994 1994 Clinicians request the FACT-G in Spanish Careful consideration of equivalence and quality are at the forefront of this endeavor. The translation group that will become FACITtrans is born. 1996 1996 A call to quality within the PRO/HRQOL community The initial manuscript on the translation and linguistic validation of the FACT scale is published. Bonomi, A.E., Cella, D.D., Hahn, E.A., Bjordal, K., Sperner, B., Gangeri, L., Bergman, B., Willems, J., Hanquet, P., & Zittoun, R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Quality of Life Research 1996; 5: 309-320. 2000 2000 The translation group’s work gains recognition The first requests to translate COAs by other developers begin. 2001 2001 The translation group publishes an article, and causes a stir Our translation group develops the first iteration of an article in support of the universal translation approach, which 20 years later is still considered methodologically novel. Advantages of the Universal Approach: Enables comparisons across subgroups, assuming the scale applied is unbiased (e.g. Spanish speaking populations in the US). Minimizes bias introduced by multiple translations in a survey or clinical trial. Reduces logistical complexity in multinational clinical trials. Facilitates survey administration in the case of migrating populations. Eremenco S., Arnold B., Cella D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions 2005; 28(2): 212-232. 2004 2004 Item banking translation begins Item banking translation begins with the PROMIS into Spanish. 2005 2005 Our translation group contributes to landmark ISPOR translation and cultural adaptation guidelines The result is the seminal manuscript, “Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient‐Reported Outcomes (PRO)” . Translation companies rush to adopt this methodology that is now accepted as industry standard. 2009 2009 The translation and formatting team formerly part of CORE becomes FACITtrans The transition from academia to a business environment frees our group to be even more responsive and streamlined, permitting more effective response times and quicker turnaround for the deadline-driven pharmaceutical clinical trial industry. Under the scientific direction of Dr. Cella, the outcomes scientists at MSS and the translation and formatting team of FACITtrans have world-class experience and expertise in translation and linguistic validation, outcomes research design, database development, multicenter data collection and management, psychometrics and statistics. 2012 2012 Adapt FACIT measures for electronic administration The FACIT Group starts to modify text for FACT and FACIT questionnaires’ use on tablets and other devices. 2017 2017 FACITtrans earns ISO 9001:2015 certification Quality processes have always been central to our work, which is why we co-founded the ISPOR translations guidelines so many years ago. In 2017 we went a step further to seek recognition on an international level for how we work. This resulted in a very rewarding moment when we received praise from the auditing agency and our ISO 9001:2015 certification. 2021 2021 FACITtrans earns ISO 17100:2015 certification Harnessing the energy from our ISO 9001:2015 certification, we placed our translation and linguistic validation processes under additional scrutiny to earn our ISO 17100:2015 certification, further reinforcing our high quality work. Today Today Collaboration is our strength While most of our work is for top pharmaceutical companies, we regularly partner with Dr. Cella’s research program at Northwestern University - the largest academically-based outcomes research group in the world. We also collaborate on NIH initiatives such as PROMIS, and with industry leaders like C-Path. Our President, Benjamin Arnold, and Executive Director, Emily Parks-Vernizzi, served as Co-Chairs during separate terms, and are now permanent steering committee members of ISOQOL’s Translation and Cultural Adaptation Special Interest Group (TCA-SIG). Meet the Team Benjamin Arnold, MA President Emily Parks-Vernizzi, MBA Executive Director MEET THE WHOLE TEAM FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

Clinical outcomes assessment (COA) translation, linguistic validation and cross-cultural assessment with over 25 years expertise providing cutting edge services and consultation to health outcomes researchers in the pharmaceutical industry and in federally-funded initiatives. Translation & Linguistic Validation FOR THE LIFE SCIENCE AND HEALTH STATUS RESEARCH COMMUNITIES We are an industry pioneer in clinical outcome assessment (COA) translation, linguistic validation and cross-cultural assessment with over 25 years expertise providing cutting edge services and consultation to health outcomes researchers in the pharmaceutical industry and in federally-funded initiatives. While our work began with the renowned FACIT Measurement System, it has broadened to include a variety of Clinical Outcome Assessments (COAs) providing valuable services over a broad range of disease areas. We offer a wide range of services for your studies: Linguistic Validation Translatability Assessment Translation of Consent Forms and Protocols Interview Transcription and Translation eCOA Adaptation and Migration We look forward to serving your study needs. Contact us to get started! Clinical Outcome Assessments (COA) Translation Most outcomes measures have been developed and validated in English. In order to ensure that data collected in multinational clinical trials can be pooled for analysis and ultimately submitted for a label claim, translated versions of COA's must be as conceptually and culturally equivalent as possible. To achieve this equivalence, a rigorous translation methodology with attendant focus on quality and cultural appropriateness is imperative. Through our industry-wide recognized translation approach, we deliver on the promise that our translations are linguistically and culturally appropriate for each target population, and that patients across the globe understand translated items as intended by the English source instrument. Linguistic Validation Patients live with their disease, treatment or conditions. As such, patients themselves provide the most informative, useful perspective on a questionnaire's (COA’s) content. FACITtrans’ full COA translation methodology specifically requires interviewing patients with the translated questionnaire and asking them questions about the items in order to fully capture the target-language patient’s voice and experience. This process, called “cognitive interviewing”, helps ensure the final translated versions are as conceptually and culturally equivalent as possible. These steps seek to affirm the linguistic validity of the translated measure and ultimately strengthen our clients’ ability to understand the multinational patient perspective and obtain a label claim from internationally-collected clinical trial data. At FACITtrans, we believe capturing the patient voice is imperative. As highlighted on our History page, our team was part of the original publication of these now widely-accepted translation approaches. For over 20 years our mission has been Providing A Voice for Patients Worldwide. We deliver on this promise to patients and our clients every day. eCOA Translation, Adaptation, Migration and Screenshot Proofreading Electronic Clinical Outcome Assessment (eCOA) is a way of capturing data electronically in clinical trials. Many measures were developed for paper administration. When adapted for electronic assessment, often there must be some adjustments to the measure’s instructions or layout. FACITtrans’ eCOA expertise includes: Adapted over 90% of FACIT scales into as many as 70 languages Adapted over 15 non-FACIT instruments into as many as 30 languages Currently supporting >15 pharma clients & eCOA vendors FACITtrans provides these services: Instruction adaptation for clear patient comprehension Adapt language to fit context of device Multilingual migration to XML, JSON and CSV formats Screenshot proofing across variety of electronic platforms Learn about FACTtrans’ expertise with eCOA’s Interview Transcription & Translation Conducting interviews in other countries, but need transcripts of the interview in English? We have years of experience transcribing interviews, and translating the interviews into English for you. Quality checks are scheduled at each step of the process. Translation of Consent forms, Diaries, Event Logs and Protocols As longtime members of an academic research community (it's where we got our start!) we are well versed in the administrative and legal requirements of clinical trial research. Standardized documentation such as diaries, event logs, or legal/administrative documentation like consent forms or protocols require simpler translation methods but with rigorous quality and semantic monitoring. Translatability Assessment and Concept Definition COA measures are most-often developed in English, and certain concepts may not translate easily or prove to have limited or no conceptual equivalence in other cultures. Translatability Assessment refers to the proactive process of identifying such issues as early in the instrument development process as possible. Concept definition, also referred to as concept elaboration, goes hand in hand with this process and serves to define terminology and intended meaning of items providing acceptable translation alternatives, unacceptable translation alternatives, and offering solutions for specific translation issues within linguistic families. Engagement with instrument developers is crucial at these key stages to ensure the intended meaning of each item is conveyed to produce translated items that say what they mean and mean what they say. FAQ Services Quality in and across projects, no rework. LEARN MORE Publications Active contributors in the fields of translation and COAs. LEARN MORE Affiliations Sponsor and contributor for 25+ years, ISOQOL, ISPOR, ATA, and more. LEARN MORE Label Claims Our translations in label claims. LEARN MORE FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

Providing a voice for patients worldwide for over 25 years. FACITtrans History OVER 25 YEARS OF GROUND-BREAKING COA TRANSLATIONS FACITtrans Team PROVIDING A VOICE FOR PATIENTS WORLDWIDE FOR OVER 25 YEARS Benjamin Arnold, MA President BIO Emily Parks-Vernizzi, MBA Executive Director BIO Abigail Boucher, BA Senior COA Translations Manager - Life Sciences, PROMIS® Lead BIO Jason Bredle, MFA Director, FACIT.org BIO Paul Cella, PhD COA Translations Manager - Life Sciences; AI & Automation Specialist BIO Scott Debb, MA, EdD Report Writer - Life Sciences, Research Data Protection Officer (RDPO) BIO Bob Guillen, BA Senior COA Translations & Account Manager - Life Sciences; Embedded Interview Lead BIO Tamara Herzberg, MBA Strategic Initiatives and Vendor Management Lead – Life Sciences BIO Mònica Jover, MA COA Translations Manager – Life Sciences BIO Rouida Khatab, MSc COA Translations Manager – Life Sciences Vendor Management Specialist BIO Neil Ludwig, BA Report Writer - Life Sciences, Translation Technology Specialist BIO Hara Marks, MSJ Chief Quality Officer, Report Writer - Life Sciences BIO Edit Nagy, MA COA Translations Manager - Life Sciences BIO Gabriella Nagy, PhD COA Translations Manager - Life Sciences BIO Alain Nguyen, MA COA Translations Manager - Life Sciences BIO Bárbara Pérez, MA Senior COA Translations Manager - Life Sciences, Translation Technology Lead BIO Luke Pickard, MBA Director of IT, Data Protection Officer (IT DPO) BIO María Rodríguez, MA COA Translations Manager - Life Sciences BIO Shannon Romo Financial Manager BIO Lillian Savic, BA Senior COA Translations Manager - Life Sciences, Account Manager, C-Path Lead BIO Lauren Lent, DHA, MS Founder, The FACIT Group BIO FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified. Our History Over 25 years of methodologically rigorous COA translations. LEARN MORE Our Vision, Mission, and Values At FACIT, our passion is the patient. Our mission is to provide a voice for patients worldwide. LEARN MORE

FACIT Group: Patient-centered outcomes services for clinical trials. Capturing, measuring, translating, linguistically validating and interpreting patients’ perspectives of their disease, treatment or condition. The FACIT Searchable Item Library A comprehensive collection of validated quality-of-life items for chronic illness
and treatment outcomes for use in customizable forms. EXPLORE THE LIBRARY Welcome to FACIT Welcome to FACIT Together we are pioneers in the field of patient-centered research with 25+ years of cutting-edge science and services. FACITtrans provides clinical outcomes assessment (COA) translatability assessment, questionnaire, consent form and protocol translation, interview transcription and translation, eCOA adaptation and migration, linguistic validation and more. FACIT.org manages the distribution of and information related to more than 100 questionnaires that measure health-related quality of life for people with chronic illnesses. All items in the FACIT Searchable library were created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages into which each item has been translated. A 不 Translation & Linguistic Validation Services FACIT Measurement System FACIT Searchable Library COA Management & Licensing Services NEWS Introducing the FACT-ICM-17 , a brief, validated measure developed to assess the most common, distressing, and clinically useful symptomatic ICM-related immune-related adverse events. Need help? Contact us.

View all available languages for this measure. BACK FACT-Cog Languages Arabic Bulgarian Chinese - Simplified Chinese - Traditional Czech Danish Dutch English Estonian Farsi French German Greek Hebrew Hungarian Indonesian Italian Japanese Kannada Korean Latvian Malay Norwegian Polish Portuguese Romanian Russian Slovak Slovene Spanish Swedish Turkish Ukrainian

View all available languages for this measure. BACK COST Languages Amharic Arabic Bengali Chinese - Simplified Chinese – Traditional Czech Danish Dutch English Finnish French German Greek Haitian Creole Hebrew Hindi Hungarian Indonesian Italian Kannada Korean Lingala Lithuanian Malay Marathi Nepali Odia Portuguese Russian Sinhala Slovak Slovene Spanish Swedish Tamil Telugu

FACT-HN-RAD Functional Assessment of Cancer Therapy – Head & Neck Radiotherapy Index For patients with Head & Neck cancer undergoing radiotherapy LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The FACT-HN-RAD captures the most common patient- and physician-reported adverse events related to radiotherapy for patients with head and neck cancer, as well as providing a way to monitor patient-reported treatment-related adverse events and recovery over time in both clinical and research settings. MEASURE NAME: Functional Assessment of Cancer Therapy – Head & Neck Radiotherapy Index (FACT-HN-RAD) VERSION: 1 NUMBER OF ITEMS: 8 PATIENT POPULATION: Head & neck cancer patients 18 years and older undergoing radiotherapy treatment RECALL PERIOD: Past 7 days RESPONSE SCALE: 5 point Likert-type scale DATA COLLECTION: Paper and electronic ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Radiotherapy index TIME FOR COMPLETION: Less than 5 minutes SCORING: Manual scoring template, some items are reverse scored. RELATED MEASURES: FHNSI , NFHNSI-22 , FACT-HN DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-HN-RAD can be obtained by registering for permission. Users are not permitted to translate the FACT-HN-RAD without permission from FACIT.org. Permission from FACIT.org to translate the FACT-HN-RAD may also be contingent upon timeline expectations and availability of FACIT staff. Translations must undergo a rigorous methodology under the guidance of FACIT.org which includes multiple translators, QA steps and cognitive interviews with patients. For commercial use, FACITtrans is the approved translation vendor to translate the FACIT measurement system. Please contact us for more information. VIEW AVAILABLE LANGUAGES Language Availability Licensing Licensing Licensing fees are assessed on a per trial/per measure basis for commercial use. There is no fee for use of the English version, but a license should be obtained. Non-commercial use is assessed on a case-by-case basis. Licensing fees are typically not applied to investigator-initiated research, students, or clinical use. To license an available version of this measure for commercial or non-commercial use, please complete our registration form . All of the information provided in the form will be kept strictly confidential. For questions, please contact us . LICENSE THIS MEASURE Selected References Selected References Gharzai LA, Mierzwa ML, Peipert JD, Kirtane K, Casper K, Yadav P, Rothrock N, Cella D, Shaunfield S. Monitoring Adverse Effects of Radiation Therapy in Patients With Head and Neck Cancer: The FACT-HN-RAD Patient-Reported Outcome Measure. JAMA Otolaryngol Head Neck Surg . 2023 Oct 1;149(10):884-890. doi: 10.1001/jamaoto.2023.2177. PMID: 37589994; PMCID: PMC10436187. Bonomi, A.E., Cella, D.D., Hahn, E.A., Bjordal, K., Sperner, B., Gangeri, L., Bergman, B., Willems, J., Hanquet, P., & Zittoun, R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Quality of Life Research 1996; 5: 309-320. Eremenco, S., Arnold, B., Cella, D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions 2005; 28(2): 212-232. Webster K., Cella D., Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: Properties applications, and interpretation. Health and Quality of Life Outcomes 2003; 1(1): 79-85. Yost K.J., Eton D.T. Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Evaluation & the Health Professions 2005; 28(2): 172-191. LICENSE THIS MEASURE Related Measures Related Measures FHNSI Functional Assessment of Cancer Therapy Head & Neck Cancer Symptom Index - 10 Item Version LEARN MORE NFHNSI-22 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Head & Neck Cancer Symptom Index - 22 Item Version LEARN MORE FACT-HN Functional Assessment of Cancer Therapy - Head & Neck LEARN MORE