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.