QPS will meticulously manage your late phase II-IV clinical research from start to finish.
Our project management services include:
- Coordinates full range of clinical development services.
- Continuous monitoring of study progress (timelines, budget, quality, organization and communication) and optimization where possible.
- Development of a study protocol according to ICH GCP and local requirements/optimization of your study design.
- Development of all essential study documents.
- Regulatory Affairs (strategic development plan)
- Timely submissions to regulatory authorities and ethics committees.
- Selection, set-up and initiation of your study sites.
- Organization and conduct of successful investigator meetings.
- Set up and maintenance of your Trial Master File.
- Closure of clinical trial.
- Coordinating statistical analysis and reporting of your data.
- Archiving of your study files and samples.
- Individual consultancy and support in any other study related issues.