Clinical Operation & Regulatory Affairs Support
- Clinical Operations / Sponsor Representation
- Clinical Trial Liaison
- Medical Writing / Regulatory Affairs Support
- Quality Assurance Services
Many years of experience in international drug development provide the basis for our consulting activities.
- Strategic consulting
- Efficient study designs
- Organizational and process consulting
- Crisis management
We manage your study as if it were our own. We represent your goals and interests to all stakeholders of your study.
We rely on transparency, open communication with the members of the project team, a structured approach with clear target agreements and effective target control.
- International project management - CRO briefing and selection
- CRO and vendor oversight
- Milestone management
- Budget control
- Investigator recruitment
- Regulatory submissions (CTA, Ethics Committee)
Continuous motivation and scientific support of the study team are essential prerequisites for fast patient recruitment and high data quality.
We support the investigational site as well as CRA / Monitor to make your study a success.
- Scientific support of the study sites and CRAs
- Organizational support
- Study-specific training of the study team
- Measures to improve patient recruitment and processes
- Development of working tools (apps, newsletters, worksheets)
- Quality improvement measures
- Co-Monitoring / CRA-Coaching / Training
We are experienced in presenting data for regulatory purposes and medical information according to the required purpose. This includes the preparation of expert reports for regulatory applications as well as the presentation of study results in different ways.
- Clinical Overview (CTD)
- Non-Clinical Overview (CTD)
- Addendum to Clinical Overview (Renewals)
- Periodic Safety Update Reports
- Literature research
- Preparation for scientific advice
- Regulatory submissions (CTA, ethics committee)
Based on our many years of experience in quality assurance and auditing clinical studies according to ICH-GCP at home and abroad, we support you in the area of quality assurance.
- Quality Management System Consultancy
- QA / GCP Training
- SOP Review
- Preparation for inspections / pre-inspection audits