Linguistic Validation is among our main fields of activity. We can securely state that we are among the most innovative and experienced bodies providing these services to the worlds leading pharmaceutical companies, CRO’s and health outcome organizations.
We are proud to be the first cognitive debreifing provider to implement clinical research measurements in our linguistic validation process. We introduce an E6-GCP complaint process. Among our contributions:
1- Creation of a multilingual/instrument-specific informed consent for the participants in our cognitive interview process.
2- Creating Valitracks: the world’s first software managing the process of cognitive debriefing.
3- Creating Umbilicus: a patient recruiting department, specialized in recruiting patients for clinical trials.
Novimedgroup is directed by medical doctors and researchers, therefore we are very clinically oriented. We follow the last practice updates and changes in regulations in the clinical research field. Furthermore, we implement innovative procedures into our linguistic validation process, with more tech and clinical-oriented approaches.
Lately, we introduced Valitracks software, introducing a new environment for the process of linguistic validation, adding more transparency, documentation, and follow-up abilities to this process.
Our Linguistic Validation Process
Our linguistic validation process is. compliant with the industry’s best practice protocols meeting both EMA’s and FDA’s requirements.
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).
1- Translation: Linguistic validation is initiated by the creation of 2 separated 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 is 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 the 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 a 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 to the source language ( usually English), and the results are discussed with the investigators, instrument creators, 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 perform yearly more than 500 linguistic validation processes around the globe, validating instruments in more than 50 languages and in more than 30 countries.
Case study 1/50:
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, 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 to 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/skype 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 in 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, is 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 process of cognitive debriefing within linguistic validation. Compared to traditional ways of 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:
* Project management, * Electronic Forms,* Decentralized encrypted access to participants, *voice recording option, *Multilingual version creation, * Usability testing, *live track of interview progress.
For more about Valitracks.