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.