Przeprowadzenie walidacyjnych kompleksowych wieloośrodkowych badań klinicznych z udziałem ludzi wyrobu medycznego SkinSens przeznaczonego do nieinwazyjnego obrazowania medycznego w podczerwieni wyników skórnych testów alergicznych m. in vivo.

Conducting a complex validation multicentre clinical trial with the participation of humans, of the medical device Skinsens dedicated for non-invasive infrared medical imaging of the results of skin allergy tests m. in vivo.

Kody CPV:

73120000-9: Usługi eksperymentalno-badawcze

85121200-5: Specjalistyczne usługi medyczne


Termin składania ofert: 18 lipca 2022, g. 10:00 1 sierpnia 2022 r.

Dokumentacja w wersji polskiej i angielskiej

Pytania i odpowiedzi


Question regarding the ISO14155 certification: Currently [—-] is in the process of getting certified by [—-] […]and has passed multiple audits and inspections without any critical findings. It is possible to participate in the bidding process, even though the ISO certification is not available, yet?

–Zamawiający zaakceptuje oświadczenie, że oferent ma wdrożone stosowne procedury i spełnia wymogi normy ISO 14155 w zakresie realizacji badań medycznych. The contracting authority will accept a statement that the tenderer has the relevant procedures in place and meets the requirements of ISO 14155 for the execution of medical tests.


For the proposal [–] will consider Full-Trial-Services including Site Monitoring, except Study Protocol Preparation. Is this correct?

–Site monitoring is not included.


Protocol Synopsis: In you briefing document you mention that a protocol synopsis is available after signing a CDA. Exom would be happy to sign a CDA in order to receive the study synopsis. Can you please provide your CDA template for review or would you like us to provide the [–] template?

–Your CDA is enough. We prepared synopsis also in English.


Allergy Tests: In you briefing document you mention that the CRO will be responsible to purchase and distribute the Allergy Tests. Can you confirm if you have a special requirement (e.g., manufacturer) for the PRICK Tests to be used? Are there specific allergens per subject you want to test? How many allergens do you consider for the PRICK Tests?

–Described in synopsis. 14 allergens + histamine + “0”


Do you confirm that the assessments made by SkinSens are compared to the assessment of the physician making the PRICK Test?



SkinSens System Installation: In you briefing document you mention that the CRO will be responsible for distribution and installation of the SkinSens System at the sites, as well as for the site training. Will Milton Essex train the CRO staff in correctly installing and training the system at the sites? If yes, how long do you expect the training to be (i.e., # of days) and where will the training be conducted?

–System is very easy for use. installation consists of unpacking, connecting to electricity and internet. We plan 3h of training on-line or in Warsaw laboratory (up to you).


Will there be a comparator in the study or will just the SkinSens system be tested? If a comparator is used, will the study be open-label or blinded, randomized?

–Described in synopsis.


In which data format will the data of the SkinSens system be provided inclusion in the eCRF?

–Pictures: png, data: JSON.