Clinical Operation & Regulatory Affairs Support

• Consulting
• Clinical Operations / Sponsor Representation
• Clinical Trial Liaison
• Medical Writing / Regulatory Affairs Support
• Quality Assurance Services

Consulting

Many years of experience in international drug development provide the basis for our consulting activities.

• Strategic consulting
• Scientific Advice
• Efficient study designs
• Organizational and process consulting
• Crisis management

Clinical Operations / Sponsor Representation

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 – Organization of clinical trials acc. ICH-GCP
• CRO briefing and selection
• CRO and vendor oversight
• Co-Monitoring/QC
• Milestone management
• Budget control
• Investigator recruitment
• Investigator meetings
• Regulatory submissions (CTA, Ethics Committee)

Clinical Trial Liaison

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
• Quality improvement measures
• Co-Monitoring / CRA-Coaching / Training

Medical Writing / Regulatory Affairs Support

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.

• Non clinical / Clinical expert reports
• Well established use – expert report
• Literature research
• Addendum to Clinical Overview (Renewals) / Bridging Reports
• Periodic Safety Update Reports
• Preparation for scientific advice
• Regulatory submissions (CTA, ethics committee)

Quality Assurance Services

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