Clinical Trials
As an independent Clinical Research Institute (CRO) Alcedis GmbH offers all services for Clinical Research.
We realise clinical trials - Phase (I), II-IV - according to international standards (ICH, FDA) with a focus on oncology.
Our collaboration with leading clinics and consultants in own practice over many years, allows us a reliable selection of experienced test centres.
For an effective data management and Monitoring primarily we use the FDA, GCP and ICH- compliant online documentation system Alcedis MED trial.
Pharmacovigilance: Since 2007 several regulations and announcements regarding pharmacovigilance (Summary of Pharmacovigilance System – SPS) were published, which increases the importance of pharmacovigilance.
With the introduction of new functions for the pharmaceutical drug safety in Alcedis MED trial, we are now offering functions for the:
1. Dynamic identification of SUSAR
- daily SUSAR control will be possible without high effort in trials with a high number of patients
- preservation of the obligation to notify the authorities and of registration deadlines
2. Combination of recording AE (Adverse Event) and SAE (Serious Adverse Event)
- consistent recording of the assignment possibilities of the SAEs to the AEs
- no hidden SAEs, gurantee that to any AE, which is marked as a SAE, an SAE is also recorded
3. Dynamic generation of predefined lists for the annual Safety Report
As this is generated dynamically, it is available at any time without special effort on request of the authorities
Selection of relevant links concerning clinical trials and oncology
* Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)
* Paul-Ehrlich-Institut
* European Medicines Agency (EMEA)
* U.S. Food and Drug Administration (FDA)
* International Conference on Harmonisation (ICH)
* Deutsche Krebsgesellschaft e.V.
* Deutsches Krebsforschungszentrum
* Deutsche Gesellschaft für Hämatologie und Onkologie e.V.