What is the concept used by proDERM to face the challenges related to Covid-19?

We have developed our concept considering the recommendations of the Robert Koch Institute and the legal requirements. It includes a pandemic plan, an extended hygiene and safety plan and guidelines for the use of antigen tests. It ensures the applications of the AHA-L’s rules in the company, i.e.:

  • Social distancing must be respected at all times
  • Extended hygiene measures must be applied
  • A mask covering the nose and the mouth must be worn
  • All premises must be ventilated often on a regular basis

It describes differentiated set of measures taken to protect the panelists, visitors and employees. The concept also implies the nomination of commissioners that are in charge of the control and adaptation of the concept, when necessary.

  • AHA-L rules
  • Pandemic plan
  • Plan to increase hygiene and safety
  • Guidelines regarding the use of Antigen tests
  • Pandemic commissioners

How do you make use of the Antigen-test mentioned above?

By using the SARS-CoV-2 Rapid, we can determine with an accuracy > 96 % if a person is infected. With a result available within only 15 minutes, the test can easily be integrated into the study’s procedure. This helps us in detecting a case and taking appropriate measures when needed.

To our clients we offer the test as an add-on to the study. If used, we would realise the Antigen-test ahead of each subjects visit. For more information on the conditions, please contact the Business Development department.

The test is also used for internal screenings of employees.

  • The tests are performed according to the physician’s decision and clearly defined rules
  • Regular screenings are possible, based on the sponsor’s request

Is there any study that cannot be performed in times of Covid-19?

We can perform our studies with the exceptions of studies related to the investigation of Halitosis.

  • Almost all study types are possible

Can you currently run in-house studies, or do you implement ‘remote’ studies?

At the moment, all studies are run with the presence of the subjects in the premises. If circumstances arise which require a ‘remote’ study conduct, we have prepared our IT and infrastructures accordingly. Thus, a changeover to ‘remote’ is possible, provided that the study type and the associated studies allow this.

  • In-house studies
  • Remote studies

What measures have you taken to ensure hygienic conditions in your institute?

We ensure the hygienic conditions in our institute with various measurements. For example, hygienic hand disinfection must be applied before entering the institute. Surface disinfections are carried out on a regular basis. This concerns door handles and EDP equipment, but also areas with increased traffic such as kitchens or reception areas. We have installed disinfectant dispensers at strategic locations throughout the entire institute. In addition, we carry out frequent ventilation, use room air cleaners and air conditioning systems with fresh air flow.

  • Mandatory hand disinfection
  • Surface disinfection
  • Ventilation system

What changes have been implemented by proDERM with regard to the facility to prevent infection by Covid-19?

We have taken various measures related to our facility. These include the use of partition walls and Plexiglas panels, the use of floor markings and the placement of disinfectant dispensers.

  • Partition walls
  • Plexiglas panels
  • Floor markings
  • Disinfection dispenser

How do you reduce the risk of infection through measures that can affect the course of the study?

On the one hand, we implemented measures that resulted in a change in the study process in general. For example, we have changed the procedure related to the remuneration of the panelists in order to minimize contacts. In addition, we limited the number of subjects allowed in a room depending on the size of the room in question. Also the study participants are not allowed to enter the institute until their appointments. On the other hand, we check before each new project which additional, study-specific protective measures have to be taken.

  • Limited number of subjects/room size
  • Changed study procedures, e.g. issuing checks
  • Regulated access to the institute area

Have you set guidelines regarding the usage of masks at proDERM?

We have set clear guidelines concerning the requirements, as well as the use and disposal of mouth and nose protectors. This relates for example to the facial area that must be covered by a mask. The same applies to the form and type of a mask (makeshift masks such as scarves or cloths are not accepted). In general, subjects are not allowed to dispose of masks in the institute. We have developed a procedure for the internal disposal of masks and contaminated material.

If necessary, proDERM will distribute a mouth and nose protector or FFP2 masks to volunteers.

  • Face area
  • Form
  • Use mandatory
  • Disposal prohibited
  • FFP-2 Masks

Can the obligation for subjects to wear masks influence the result of a study, e.g. in the case of facial examinations?

If the protocol of a study includes assessments / examinations in the area of the face that would be covered by a mask, other physical barriers are used. These can be partitions, Plexiglas panels or visors, which are handed out to the subjects in advance. In this way, we exclude the possibility of a change in the results. If it is not possible due to the study design that neither the test person wears a mask nor alternative physical barriers can be used, a 1-subject 1 room policy is applied. In this case, the procedure can be performed without the subject wearing a mask. In these rare cases additional measures to support hygiene and safety will be applied (e.g. ventilation of rooms).

  • Valid results through flexibility regarding physical barriers

Do your protective measures include the obligation to wearing gloves?

Yes, it is obligatory for our study staff to wear gloves during the conduct of a study and during direct contact.

  • Obligatory gloves for the study staff

How do you react to a Covid-19-related exclusion of subjects?

First of all, a Covid-19 infection does not necessarily lead to exclusion from the study. Under certain circumstances it is possible to postpone the visit date of the volunteer until recovery or to conduct the study remotely.

However, if the subject is permanently excluded, standard drop out procedures will be applied.

  • If necessary and possible, rescheduling or re-recruitment is possible

How do you react to a Covid-19-related non-availability of planned study personnel?

For each study we conduct, we have sufficient personnel available as back-up. This concerns persons directly and indirectly involved in the study. This allows us to compensate for a Covid-19-related loss of personnel and to continue the study.

  • Sufficient personnel as back-up

What is the 7-day incidence value for the region where you conduct your studies?

We conduct our studies at our locations in Schenefeld and Elmshorn. Both locations belong to the district of Pinneberg in the federal state of Schleswig-Holstein. You can obtain the 7-day incidence value for the district of Pinneberg via the following link:

Arcgis

  • Incidence value at proDERM location

Do the conditions changed by Covid-19 affect the price and duration of a study?

In general, we can neither answer this with ‘Yes’ nor with ‘No’. As a matter of principle, the measures taken go far beyond legal requirements and official recommendations in terms of hygiene and safety. This can have an influence on the price or duration of a study and must be analysed on a case-by-case basis. We do not carry out general price increases.

  • No general price increases
  • Time variations only in individual cases