Study start-up – the busiest phase of a development project

Are you challenged by the multiple clinical trial start-up organizational tasks?

PPH plus takes over the lead and coordination of the clinical trial start-up activities for you.

• CRO and service partners identification and selection
• Determination of the most appropriate technology tools
• Clinical supply packaging, labeling and distribution planning
• National import/export regulations
• Customs issues
• Feasibility study, including site feasibility questionnaire preparation and response analysis
• Site identification and selection
• Organization and conduct of site selection visits
• Contract negotiation with investigative sites and third-party service providers
• Organization and moderation of ‘kick-off’ and investigator meetings
• Essential documents collection
• Clinical trial applications to regulatory authorities and ethics committees
• Preparation of the project management and ancillary plans
• Site initiation activities

PPH plus’ core competency is to orchestrate all required disciplines and contributors.