Prevention is the best therapy
PPH plus deploys a patient & customer-centric approach to prevent and mitigate risks to:
- Human subject protection
- Data reliability and
- Overall clinical study success
For this, PPH plus creates a Risk Management Plan (RMP) with tailor-made contingencies and their timing. As a living document, the RMP is being updated in line with project progress.
Risk control starts with the elimination of complexity from the clinical study protocol. PPH plus implements "Quality by Design" (QbD) and risk-based approach from the clinical study planning phase to effectively avoid preventable risks, as required by ICH, EMA and FDA.
Additionally, the close monitoring of critical risks mitigates clinical study delays and budget overruns promptly.