It does not work without YOUR input
Before a new medicinal product is introduced to the market, safety, efficacy and tolerability have to be tested. YOU have the experience with your product and we have the experience how to bring YOUR product to YOUR planned market.
One of the fields of our activity is the role of excellence in quality and guarantee of breakthrough clinical research and studies, where our expert task will be organization and supervision over the process and control of subjects and their capacities and activities involved in the realization itself. Our key asset is a guarantee of implementation and observance of local but particularly international standards of the highest quality. Within this activity, our goal is to function as a space where, within the partnerships and cooperation, either observation and audit your implemented quality system or vice versa or we provide support to your extenral partners in terms of auditing their quality systems.
Conducting of International Clinical Trials Audits as Site Audits and as Inhouse Audits or complete Study Audits.
Conducting of International Systemic Audits of Different Departments or complete Business Units in Pharma, BioTech, CRO and/or Medical Devices.
Planning and Conducting of Vendor Audits (regular and initially) for Labs, CRO service providers and documentation supporters.
Planning and conducting and leading CAPA Plans after Inspections for Pharma Companies until Re-inspections.
Planning and conducting Department Restructuring of Medical Affairs and/or PV departments (incl. IT tools and structure)
Conducting Department Restructuring of Medical Affairs and/or PV departments before or after Audits and/or Inspections.
Implementation of PV Departments (incl. restructuring of SOPs) within Pharma and CROs, incl. preparation for Inspections.
Proving trainings for CRO, Pharma and Med.Dev. staff in terms auf SOPs, Audits, Inspections, incl. preparation for this.
Generating of SOPs or auditing of SOP-Systems within Clin.Ops, Pv and Medical Affairs Departments within Pharam, BioTech and/or CRO.