Operative Study Management / Monitoring
Medicinal Products and Pharmaceuticals
On-Site Monitoring (Pre-study, Initiation, Periodic Monitoring, Close-Out-Visit) according to ICH E6(R3) GCP.
Risk-based monitoring, remote monitoring, telefon contact.
Medical Devices
On-Site Monitoring (Pre-study, Initiation, Periodic Monitoring, Close-Out-Visit) according to ISO 14155:2020 or ISO 20916:2019.
Risk-based monitoring, remote monitoring, telefon contact.
Regulatory Affairs Services
Medicinal Products and Pharmaceuticals
Sending and tracking the documents required for the approval of a clinical trial to interested trial sites (confidentiality agreement, feasibility, suitability, CV, etc.), and follow-up with the possible trial centers.
Clarify classification of your study with the authorities.
Compilation of documents for the ethics application and the application for approval to the higher federal authority.
Submission of Clinical Trial Application CTA via CTIS.
Registration/deregistration of sites at authorities, ethics committees, health insurance.
Medical Devices
Sending and tracking the documents required for the approval of a clinical trial to interested trial sites (confidentiality agreement, feasibility, suitability, CV, etc.), and follow-up with the possible trial centers.
Clarify classification (incl. risk class) of your study with the authorities.
Compilation of documents for the ethics application and the application for approval to the higher federal authority.
Submission of Clinical Trial Application CTA to ethics commission(s) /authority.
Registration/deregistration of sites at authorities, ethics committees, health insurance.