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Pilot Study ‘External Sample Infrastructure as a Surveillance Tool (EPISTool)’

In the autumn/winter of 2022/2023, the pilot study “Our Health” was conducted by PI Health Solutions on behalf of and under the direction of the Robert Koch Institute. In the process, PIHS’s experience in the field of study execution was used to test novel ways of continuous and long-term health monitoring of society. The goal is to provide a platform available in the long term, to quickly find answers to dynamically evolving questions about the health of the population and enable suitable measures, including advice to stakeholders in politics and authorities. “Our Health” was proof that the implementation concepts of PI Health Solutions can be scaled to various observational scopes and target group sizes. From regional to nationwide investigations, the feasibility is proven. The developed processes can be extended to EU-wide activities without major obstacles.

Corona-BUND Study

PI Health Solutions GmbH initiated and drafted the study protocol for this population-representative SARS-CoV-2 study in Germany. This study allows the dynamic monitoring of virus infection and seroprevalence in the entire population over an extended period of time. Study results are provided within a few weeks. This is only achieved by using 1) Social Media because it is necessary to repeatedly recruit and hire a large number of medical professionals on flexible shortterm contracts throughout Germany and 2) by using sophisticated software solutions for nationwide route planning of a swarm of study personel. Our study design also serves as a blueprint for nearterm vaccination studies in cooperation with our sister company in the PI Solutions Group GmbH, the Clinical Research Organization Pharmaimage Biomarker Solutions GmbH. The Corona-BUND Study is a public-private partnership (PPP). Members of this PPP consortium are: Charite Berlin (Profs. Winterer/Drosten), Cologne Center for Genomics der Universität zu Köln (Profs Nürnberg/Nothnagel), Ifo Institut für Wirtschaftsforschung der Universität München (Prof. Fuest), PI Health Solution GmbH (CEO Prof. Winterer), Forsa GmbH (CEOs Prof. Güllner/Thierhoff), Atlas Biolabs GmbH (CEO Prof. Nürnberg). Additional associated partners are: Labor Berlin GmbH, Limbach Labore se. Coordinator of the study is Prof. Winterer. The Corona-BUND study is an investigator-initiated study (IIS) financed by the German Ministry of Health (Bundesministerium für Gesundheit).

Vaccination studies with Corona-BUND Study Blueprint: According to WHO guidelines (Guidelines on clinical evaluation of vaccines: regulatory expectations), vaccination studies (phase-2/3) are to be conducted in specific target populations. For SARS-CoV-2 vaccination, these studies must be conducted in a populations-representative cohort covering all groups oft he population including elderly probands and probands with pre-existing illnesses. Our logistics including sophisticated monitoring, established as a blueprint in the Corona-BUND study, allows it to conduct the vaccination study with maximum speed. For instance, a vaccination study with 3-months follow-up investigations in N = 10.000 probands from the general population could be completed within four months.