Focusing on what really matters - ICH GCP expects a risk-based approach
Two key reasons why risks must be prevented:
- Quality cannot be built into a clinical trial retroactively
- Sudden rescue measures may threaten the success of your projects
The experienced PPH plus project leaders will be delighted to:
- Plan with you and manage for you clinical projects from scratch
- Help you with resolving critical issues on an ongoing project
PPH plus identifies, evaluates, controls (via risk-based monitoring), communicates, reviews and reports risks enhancing protocol compliance. Thus, PPH plus aligns state-of-the-art quality management in clinical trials with international standards, resembling the most recent ICH E6(R2), FDA and EMA guidelines, and will assist you with the optimization of quality by enhancing mere quality control with the more efficient quality-by-design (QbD) approach in the clinical research arena.
- Through well-defined and state-of-the-art risk management procedures (see RACT plus), PPH plus uncovers those risks often overlooked by traditional quality management systems
- A tailored and regularly updated Risk Management Plan ensures that risks are kept under control from study start to end
PPH plus experience enables our quick incorporation to ongoing projects for rescuing endangered clinical studies. We evaluate and select the most efficient preventive and corrective actions for regaining control over the clinical trial.