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.