BRG update on COVID-19
BRG update on COVID-19
Dear Investigators and Researchers.
In recent days, the whole world is providing heroic fight with the SARS-CoV-2 virus. We treat this situation very seriously and would like to inform you about our actions and recent decisions of Polish Government and how they will affect our collaboration.
- we take patient safety as an absolute priority in the broadly understood context of both continuation of therapy and also the current epidemiological situation
- in all activities related to the supervision of clinical trials (monitoring, audit), we take into account the current epidemiological situation and the fact that medical hospital staff are involved in activities related to SARS-CoV-2 virus infection. Therefore, audits and inspections of clinical trials are suspended.
- In case of any event that could affect the safety of clinical trial participants, the sponsor or investigator shall withdraw from conducting the clinical trial in accordance with the applicable clinical trial protocol. In this case, the sponsor and researcher are required to take appropriate measures to ensure the safety of participants. In addition, they should immediately inform the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Bioethics Committee about the situation and the security measures applied.
- New applications for clinical trial of the medicinal product will not be accepted by President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. We can expect it will be also negatively considered by Bioethics Committee.
- The inspection activities of clinical trials are suspended until the end of April 2020, and the decision to resume the inspection process will be taken depending on the epidemiological situation.
- All BRG employees follow recommendations by WHO and local government organizations in terms of safety and personal hygiene.
- we limit any visits to our Clinical Center to the most necessary, promoting remote communication.
Currently we assume no changes in current studies. Bio Research as a clinical center remains at the disposal of pharmaceutical companies and CRO centers in term of new drugs, treatment or medical therapies development, which can be redeem after the epidemic ends.
We hope that current situation will not cause any disturbance. In case of any questions or doubts please free to contact us firstname.lastname@example.org
We will keep you updated on the situation