Linguistic Validation for COAs

 


 

A Measure of Confidence for Global Studies

TransPerfect’s Linguistic Validation group specializes in translating and adapting Clinical Outcome Assessments (COAs) across a variety of therapeutic areas. As the industry’s foremost experts in linguistic validation, our process is designed to ensure conceptual equivalence and cultural appropriateness in any language, minimizing time-to-market, mitigating risk, and ensuring regulatory compliance in global studies.

Clinical Outcome Assessments

The complex and increasingly regulated process of adapting COA instruments for use in global research studies demands that we keep abreast of the latest guidance on linguistic validation methodology (FDA PRO Guidance, EMA guidelines, and ISPOR Good Practice recommendations). Our comprehensive COA solutions include:  


  • Translation and Linguistic Validation of Clinical Outcome Assessments 

  • (PRO, ClinRO, PerfO, and ObsRO) 

  • Licensing / Copyright Services

  • Face Validity Assessment

  • Translatability Evaluation

  • eCOA Integration and Usability Testing

  • Cognitive Debriefing for Source Questionnaires

  • Web-Based COA Library and Online Document Management

  • IVRS Prompt Recording

  • Interview Transcription

  • Study Binder Formatting

  • Research Abstracts / Posters / Manuscripts

eCOA Integration and Equivalence Testing

eCOA
Upload and Integration
eCOA
Usability
Testing
Paper to
eCOA Content
Adaptation

TransPerfect enjoys strong and long-standing relationships with leading eCOA technology firms, and our close cooperation and integration capabilities mean that we have industry-leading solutions to support multilingual eCOA usage. 

Whether your scales start as pen-paper or eCOA content, TransPerfect’s eCOA integration solutions can fit into your workflows.

Pen-Paper and eCOA delivery each have their place, and each medium presents unique challenges and language that must be adapted. Our process is the industry’s simplest to ensure that final, linguistically validated scales are properly uploaded in industry-standard formats and software specific for each eCOA vendor. Once the eCOA vendor has generated the screenshots TransPerfect conducts an intensive testing and proofreading process to ensure no issues were introduced to the language during programming and that language expansion has not resulted in broken strings, formatting issues, or missing text. 

TransPerfect’s established partnerships with leading providers of study design and psychometric solutions ensure that equivalence between paper-administered COAs and electronic versions is tested and established, in accordance to ISPOR’s Task Force guidelines. 

Rater Training

TransPerfect Linguistic Validation provides a comprehensive suite of solutions to support rater training efforts. We offer translation and adaptation of all training materials, including those delivered by video and through interactive e-learning courses. TransPerfect has over 1,200 clinician reviewers in our network to review any ClinRO work, from neuropsychologists to urologists and almost anything in between.

Our studio services include professional subtitling as well as voiceover and dubbing using our unparalleled selection of professional voice talent and fully equipped in-house recording studios. Our experienced studio supervisors oversee each recording session and ensure that the highest standards are maintained. 

In addition, for e-learning courses, TransPerfect works directly with course authors to adapt training courses with measurable goals and objectives in mind. Far from a standard word-for-word translation, TransPerfect’s global training consultants work to understand the unique goals of your course and work with carefully selected linguists to ensure that the final product is linguistically accurate, culturally appropriate, and technically sound. 

Training Material Translation
E-Learning Platform Internationalization
Studio Services – Voiceover/Subtitling
Conference Interpretation

Web-Based COA Library
and Online Document Management


21 CFR Part 11 Solution

Web-Based Secure Archive

24 / 7 / 365
Access

Fully indexed and searchable

TransPerfect’s 21 CFR Part 11 compliant Trial Interactive online document repository allows for web-based archiving of COAs for easy access and retrieval. It stores all clinical outcome assessments (PRO, ClinRO, ObsRO, PerfO), as well as documentation from the development of the assessments, licensing / copyright information, final (linguistic validation) reports, certifications, all relevant eCOA documentation and screenshots, final PRO Batteries, and any additional documentation in the cloud. 

Files in Trial Interactive are fully indexed and searchable, and it also serves as a workflow management tool to track and manage all ongoing activities surrounding formatting projects, eCOA projects, translation projects, and the management of COA content. Available in over 20 languages, Trial Interactive is the only tool of its kind that allows users from all over the world to navigate the program in their native languages. 

Study Binder Formatting

TransPerfect’s professional formatting teams regularly assist our clients in formatting their study binders for the administration of COAs. TransPerfect’s expert team compiles the required files in all languages, implements the required margins, headers, visit and study numbers, and footers, and formats all the required documents together to meet your study needs and ensure your binders are ready for immediate printing.

Translatability Evaluation

Some expressions, concepts, and terms found in COAs present challenges far greater than standard translation or copy adaptation. TransPerfect’s translatability evaluation process helps clients proactively avoid problems that may arise later in the process. 

Without assessing translatability and source language in advance, problems may arise after a COA has been finalized and linguistic validation has begun, resulting in costly backtracking and repeated work.

When potentially problematic items are identified in the development stage, they can be revised, removed, replaced, or sidestepped to create a source language instrument better positioned for translation with fewer conceptual equivalence difficulties. This new approach results in a more internationally appropriate instrument as well as cost and time savings in linguistic validation. 

Face Validity Assessment

TransPerfect conducts face validity assessments by reviewing the questions and response sets, as well as having untrained individuals complete the measure, then obtaining feedback by debriefing. This aids in the identification of problematic wording, non-pertinent information, confusing instructions, as well as conceptual ambiguity.

During this assessment, TransPerfect works closely with the developer(s) to define and clarify concepts. The evaluation also covers cohesiveness of questions to responses, and gradation differences between item response options. 

Quality Data accuracy improves patient safety

By providing the highest level of linguistic quality in every project we complete, whether working with sponsors, CROs, or scale developers, we ensure study objectives and standards are met.

All TransPerfect Linguistic Validation production staff complete ongoing Good Clinical Practice (GCP) training, which is unique in the industry and contributes to the high quality of our deliverables. Our clients also have access to ongoing training on the most up-to-date industry standards for the translation of clinical outcome assessments as well as full-service consulting resources.

 

Linguistic Qualifications

TransPerfect’s linguistic validation linguists have extensive knowledge of industry standards as stated in FDA, EMA, and ISPOR Guidance documents. As an ISO- and EN-certified company, TransPerfect’s linguists are required to comply with such international standards as well, and undergo regular audits for quality assurance.

Native speaker of target language
Rigorously tested (6% pass rate)
Life sciences expertise
TLC Certified
Ongoing performance audits

 

Linguistic Validation Group Credentials

TransPerfect’s experts are active members of ISOQOL and ISPOR, and act as peer reviewers for several scientific journals as well as international conferences.

 

Therapeutic Areas

  • Aesthetic Medicine
  • Cardiology
  • CNS/Neurology/Psychiatry
  • Congenital/Hereditary Diseases
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Genetic Disease
  • Healthy Volunteers
  • Hemic/Lymphatic
  • Hepatology
  • Immunology
  • Infectious Diseases
  • Musculoskeletal
  • Nephrology
  • Neurology
  • Obstetrics/Gynecology
  • Oncology
  • Ophthalmology
  • Otolaryngology
  • Otorhinolaryngology
  • Orthopedics
  • Pediatrics
  • Pain
  • Plastic Surgery
  • Psychiatry/Psycholgoy
  • Respiratory
  • Rheumatology
  • Sexual Functioning
  • Sleep Disorders
  • Spondylitis
  • Trauma
  • Urology
  • Vaccines

Industry Expertise

 

Certifications & Memberships
 

TransPerfect is an active participant in the outcomes research and health economics world and has a strong record of academic achievement and participation.

 


 

Articles | Posters | Workshops
 

Koller, M, Kantzer V, Mear I, Zarzar K, et al.

THE PROCESS OF RECONCILIATION: EVALUATION OF GUIDELINES FOR TRANSLATING QUALITY-OF-LIFE QUESTIONNAIRES

Expert Rev. Pharmacoecon. Outcomes Res. 12(2), 189–197 (2012)

Sweeney, E., Kelley, T.

THE IMPORTANCE OF MIGRATION ASSESSMENTS: eCOA TRANSLATIONS AND LINGUISTIC VALIDATION

ISPOR Amsterdam, November 2014

Apfelbacher, C1,9, Bauer, A4,5, Diepgen, TL1, Elsner, P7, Mahler, V6, Molin, S3, Popielnicki, A2, Schmitt, J5,8, Weisshaar, E1, Ofenloch,

RF1 - SEVERITY AND FUNCTIONAL DISABILITY OF PATIENTS WITH OCCUPATIONAL CONTACT DERMATITIS: VALIDATION OF THE GERMAN VERSION OF THE OCCUPATIONAL CONTACT DERMATITIS DISEASE SEVERITY INDEX (ODDI)

ISPOR Amsterdam, November 2014

Dawsey R1, Sweeney E2, Plowright R3, Wilson A3, Bradley C3,4.

LINGUISTIC VALIDATION OF THE DTSQ: CHALLENGES WITH ARABIC AND FRENCH FOR ALGERIA

ISPOR Montreal, May/June 2014

Dawsey R1, Nakonechny A2, Popielnicki A3, Shi Y4, Sydor B5.

SPONSORING SPANISH-LANGUAGE TRANSLATIONS IN US-BASED CLINICAL TRIALS

ISPOR Montreal, May/June 2014

Sweeney E1, Popielnicki A2.

THE IMPORTANCE OF DEVELOPING COUNTRY-SPECIFIC VERSIONS OF SPANISH-LANGUAGE CLINICAL OUTCOME ASSESSMENTS (COAs) DURING LINGUISTIC VALIDATION

ISPOR Montreal, May/June 2014

Simon M, Zarzar K, Settar C.

METHODOLOGY FOR NEUROPSYCHOLOGICAL ASSESSMENT WORDLIST ADAPTATION

Zarzar K, Chulis C, Simon M.

FINAL REPORTS FOR TRANSLATION AND LINGUISTIC VALIDATION OF CLINICAL OUTCOME ASSESSMENTS

ISPOR Berlin, November 2012.

Zarzar, KM.

REVIEW OF CLINICIAN AND OBSERVER REPORTED OUTCOMES MEASURES TRANSLATION METHODOLOGIES

ISPOR Madrid, November 2011.

Dawsey, R. Zarzar, KM.

LINGUISTIC VALIDATION IN MULTIPLE PATIENT POPULATIONS

ISPOR New Orleans, May 2013.

Chulis, C., Moravec, H., Sweeney E.

RECOMMENDATIONS FOR THE SUCCESSFUL LINGUISTIC VALIDATION OF CLINICAL OUTCOME ASSESSMENTS FOR LIMITED PATIENT POPULATIONS

ISPOR Dublin, November 2013.

Sweeney, E., Nakonechny, A.

DEFINING STANDARDS OF CLINICIAN QUALIFICATIONS FOR THE LINGUISTIC VALIDATION OF CLINICAL OUTCOME ASSESSMENTS (COAs)

ISPOR Dublin, November 2013

Dawsey R, Zarzar K.

LINGUISTIC VALIDATION AND EPRO: THE VALUE OF COLLABORATION

ISPOR Madrid, November 2011.

Simon, M., Sweeney E., Moravec, H.

A REVIEW OF COGNITIVE INTERVIEWING METHODOLOGIES DURING TRANSLATION AND LINGUISTIC VALIDATION OF CLINICAL OUTCOME ASSESSMENTS

ISPOR Dublin, November 2013.

Zarzar, K(1), Tan, R(2).

Linguistic Validation of the National Eye Institute – Quality of Life Questionnaire – 42 (NEI-RQL-42) for Patients with Refractive Error: Mandarin in Mainland China and Hindi in India.

ISPOR Asia-Pacific, September 2010.

Becca Dawsey, Katie Zarzar

LINGUISTIC VALIDATION IN MULTIPLE PATIENT POPULATIONS: COGNITIVE INTERVIEWING APPROACHES

ISPOR US, May 2013

Eric Gemmen, Shital Kamble, Katie Zarzar, Becca Dawsey

THE CORRELATION BETWEEN PATIENT REPORTED OUTCOMES AND CLINICIAN REPORTED OUTCOMES (in collaboration with Quintiles)

ISPOR US, May 2013

Anna Nakonechny, Katie Zarzar

CLINICAL OUTCOME ASSESSMENTS AND RATER TRAINING MATERIALS - MAXIMIZING CONSISTENCY

ISPOR US, May 2013

Eric Gemmen, Shital Kamble, Katie Zarzar, Becca Dawsey

THE CORRELATION BETWEEN PATIENT REPORTED OUTCOMES AND CLINICIAN REPORTED OUTCOMES (in collaboration with Quintiles)

ISPOR Dublin, November 2013


 


 

Industry Guidance Materials
 

ISPOR Guidance for Translation
& Cultural Adaptation of PROs

FDA Guidance on PROs
 

ISPOR ePRO Good Research Practices
Task Force Report

TransPerfect
is committed to following the highest standards for quality and client service in the translation industry.

Client List

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