eCOA Solutions

eCOASolutions

 

 

A Measure of Confidence for Global Studies

TransPerfect Life Sciences’ eCOA Solutions group specializes in consultation for the integration of eCOAs into global clinical trials and healthcare practices. Our group supports licensing, translating, and adapting Clinical Outcome Assessments (COAs) across a variety of therapeutic areas, and integration to eCOA. As the industry’s foremost experts in linguistic validation and eCOA migration, 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.

Translation & Linguistic Validation of Clinical Outcome Assessments (eCOAs)

The complex and regulated process of adapting eCOA 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 eCOA 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

Electronic Clinical Outcome Assessments (eCOA) Services

From COA licensing to post-localization testing, we offer eCOA vendors a centralized translation process that increases quality and reduced costs and timelines. With partnerships with more than 50 developers and copyright holders and 400 linguistic and functional testers for post-localization testing, our teams can provide end-to-end eCOA project cycle support including:

  • Licensing
  • Translation/Linguistic Validation
  • Migration Assessment
  • eCOA Adaptation & Migration
  • Screenshot Review & Certification
  • Post-Localization Device Testing

eCOA Migration Tools

GlobalLink XCompare: Innovation in eCOA Migration

Throughout the years, TransPerfect Life Sciences has identified a gap in the migration process from paper to electronic. Today, we are the leader in innovation in eCOA migration with our breakthrough technology, GlobalLink XCompare.

XCompare is our proprietary risk-mitigating technology used during the migration of validated paper COAs to electronic platforms. It reduces migration errors by 97% and speeds up review rounds by 50%. Learn more and request a free QC check of your translations here.

Applanga: the Future of eCOA Migration

The future of eCOA migration is a fully complete integration that removes the need for passing technical files back and forth and rounds of review.

Applanga is a proprietary technology that connects directly to the ePRO/eCOA app itself via an API. This allows for TransPerfect to take on the full testing process and remove the ePRO vendor from that back and forth, resulting in a 2.5 times faster turnaround time and reduced project management.

eCOA Integration & On-Device Usability Testing

Paper to eCOA Content Adaptation

TransPerfect Life Sciences 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 electronic clinical outcome assessments.

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

Pen-paper and eCOA delivery each have their place, and each medium presents unique challenges and languages that must be adapted. Our automated 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 did not result in broken strings, formatting issues or missing text. 

eCOA Usability Testing

TransPerfect offers a systematic and industry-level standard approach to evaluate the use of electronic Clinical Outcomes Assessments (eCOAs). In compliance with industry-level standards, TransPerfect conducts face-to-face interviews with individuals who meet your inclusion criteria to assess the usability of your device and software. Our approach includes an evaluation of intuition, ease of use, visibility, readability, as well as a report on proposed improvements and recommendations. We strive to create a user-focused experience by evaluating patient feedback to improve progress tracking and patient device interaction.

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

COA Library and 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 COA Division production staff complete ongoing Good Clinical Practice (GCP) training, which 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.