We Provide The Whole Package Of Linguistic Validation
Virtual Cognitive Debriefing Platform.
Local Medical Debriefing Experts.
Wholesome Digital Documentation Process.
We are exclusively specialized in the linguistic validation process
Our linguistic validation process is compliant with the industry’s best practice protocols meeting both EMA’s and FDA’s requirements for COA development.
Linguistic validation is a process that regulatory bodies require to verify the accuracy and credibility of instruments that are to be used on people usually as part of clinical research or clinical practice. The validation process might include instruments that are addressing patients, clinicians, research participants, or medical staff ( PRO, COA, ClinRo, ObsRo, PerfO).
Detailed Summary Report.
Quality Cognitive Debriefing Interviews.
Clinical Expert Review.
1- Translation: Linguistic validation is initiated by the creation of two separate translations of the source document.
2-Reconciled version: the 2 translations are assessed and a reconciled version of the 2 translations is created after a discussion created by the project manager with the 2 translators.
3- Back translation process is initiated in which the reconciled version is translated back to the source document’s language (usually English), afterwards, the project manager discusses the documents with the linguists and with the client and implements the needed changes.
For project managers: We make sure to appoint medical doctors or medical researchers, although it is not explicitly required by regulators, it is indeed a very important factor to make sure that the instruments are appropriately produced to suit the local population ( patients, clinicians, etc…).
4- Cognitive debriefing:
This is the stage in which linguistic research is moving from the “in vitro stage” into the “in vivo stage”. Cognitive debriefing is the process in which the instrument is tested on actual participants and the understanding of those participants is assessed.
A- Recruitiment: Our recruitment department ” umbilicus”, recruits the target population of the patients ( depending on the clients/research inclusion/ exclusion criteria).
Recruitment criteria vary, however, usually the minimal accepted number of patients needed to properly research the instrument is 5.
Inclusion criteria might include, sex, age, occupation, education, and disease.
B- Cognitive interviews:
An experienced clinical interviewer meets the participants for an interview, usually face to face, or by video call (in some cases). The understanding of the participants is assessed and documented via software called Valitracks. The investigators, client, and regulators can have live access to the results and progress of the interviews, comment, ask and interact with the interviewer to be able to increase the speed of the validation and thus the speed of the clinical research/ instrument release.
C- Summary Report:
After the interviews have been completed, the report results are translated into the source language ( usually English), and the results are discussed with the investigators, instrument creators, and clients. Sometimes, another round of questions is required and the interviewer is asked to redo some questions in order to clarify some points.
Eventually, the results are shared with the project manager, and recommendations are made based on them, finally, the final version of the document is created.
We Have Proven Experience
We perform yearly more than 500 linguistic validation processes around the globe, validating instruments in more than 50 languages and in more than 30 countries.
In this study, another LSP performed the translation steps. NovimedGroup was in charge of the cognitive debriefing step. We initiated our recruitment process by recruiting patients that suffered from Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria. The Languages to be tested have been: Simplified Chinese/ China, Afrikaans/south Africa, Spanish/Argentina, Swedish/Sweden, Turkish/Turkey, and Italian/Italy. Furthermore, our team performed the whole process of linguistic validation (including the translations and cognitive debriefing) for the following countries: Hebrew/Israel, Sesotho/South Africa, Gujarati/India.
Our translation process included 3 medical doctors as project managers and 9 linguists in the 3 countries performing the translation and the back-translation steps. The translation step took 12 days to produce a final document ready for cognitive debriefing.
Simultaneously with the translation, Umbilicus started with the recruitment efforts. The recruitment process was completed within 2 weeks.
2 patients have been recruited for each disease in each locality. Male to Female ratio was almost 1:1, furthermore, various occupational backgrounds and educational levels have been included in each locality. Vast medical knowledge was an exclusion criterion as it might bias the results.
Due to the Covid-19 restrictions, interviews have been conducted in 2 forms, face-to-face and zoom/Valitracks interviews.
The interviewer created a summary form per each language and translated the results into English as well. The cognitive debriefing process with the summary file creation took 2 weeks covering all languages.
The project managers had some questions for the interviewer in Simplified Chinese and Italian. The interviewers in those languages contacted the participants again and retested some segments as the project manager asked. This second round took 3 days to complete.
Finally, final reports have been created for all instruments (PNH and AA) in all 9 localities. The recommendations included 2 amendments in the Swedish version, 4 changes in the Italian version, 1 change in the Chinese version, and 3 changes in the Turkish version.
For more case studies (2-50), including different instruments, localities, populations, etc., please book a meeting to further elaborate on our expertise.
To be able to meet the E6-GCP requirements and to create a detached decentralized process, ensuring the safety of patient data we created Umbilicus.
“Umbilicus” is a detached entity that is exclusively dealing with patient recruitment for clinical research and cognitive interviews.
We consider cognitive debreifing as a full clinical process, and therefore we implement clinical research regulations into the process of recruiting.
We use clinically accepted methods of recruitment including:
internet advertisement, newspaper advertisement, hospital or clinic advertisement, visits to health centers and clinics, contacting potential participants stored in our database, utilizing relationships with clinicians and health care providers, and building patient groups for clinical research.
We have direct access to more than 5000 patients and 100 clinics around the world. We have conducted more than 1000 recruitment studies a year collaborating with over 100 centers and in around 50 countries.
Among the services that Umbilicus provides, are the feasibility studies for the recruitment process. It includes a timeframe for the completion of a given study, the feasibility/difficulty, recommendations regarding the sample size, and inclusion and exclusion criteria.
To further discuss Umbilicus services and share case studies, book a meeting.
Valitracks is the first software to manage the whole process of linguistic validation. Compared to traditional ways of linguistic validation and cognitive debriefing, Valitracks enhances the level of documentation provided to clients and shortens the process of cognitive debreifing by 25% on average.
Among the abilities of Valitracks:
* Customized CAT tool for translation.
* Multistep-Validation Process.
* Decentralized encrypted access to participants.
*Interactive video-virtual debriefing platform.
*Voice recording option.
*Voice Masking option.
*Multilingual version creation,
* Usability testing,
*live track of interview progress.
*Detailed documentation report generation for each step.
For more about Valitracks.
If you like to discuss any specific project or explore more about our abilities, give us a call.+1-302-415-3221 +30-694-066-3670 Contact us