Clinical studies
From the planning of the study design to the final study report and marketing authorization
Pharma Expertise Consulting accompanies you both in the conduct of in vitro trials prior to clinical studies (Fraunhofer Institutes etc.) and in the planning and execution of a Phase II to IV clinical trial by a Contract Research Organization (CRO) or a contract research organization. We work strictly according to Good Clinical Practice (GCP), the German Data Protection Regulation (DSGVO) and national and international laws and guidelines.
We support you in all tasks: the organization and planning of the study, selection of a suitable CRO, contracting (delimitation of responsibility contracts), observation plan or study protocol (synopsis), submission/notification to the authorities Federal Institute for Drugs and Medical Devices (BfArM), ethics committees, and umbrella organization of the health insurance funds), database creation and randomization, monitoring and data collection, and statistical analyses (biometrics or biostatistics) in a Statistical Analysis Plan (SAP), as well as the final report in the context of medical writing.
We take over individual services, but also offer a full service. Please do not hesitate to contact us!
Our services in the field of clinical trials of pharmaceuticals:
Planning of the study design/
Study procedure
Selection of qualified study sites / contract design
Audits for review and evaluation of study centers
Instruction of investigators
Communication with authorities
(approvals of the ethics committee etc.)
Conclusion of patient insurance policies
Compliance with the study plan / legally compliant conduct of the study in accordance with Good Clinical Practice
Statistical evaluations
Control of compliance with timelines / planned study budget
Remuneration of the study physicians
Monitoring / communication with the clinical research associates (CRAs) at the study sites, Principal Investigator and the sponsor
Source Data Verification (SDV) through CRA-compliant reporting of serious adverse events
(SAEs)
Registration of study results in the appropriate databases