PROJECT MANAGEMENT

	Outsourcing of project management to ECRON means
		all decisions, organizational, medical and economic, are handled by one study manager
		one person responsible for the client with direct phone access

Pre-study Phase

• investigator selection and recruitment
• pre-study visits and facility check
• investigator meetings
• initiation visits
• national regulatory affairs and Ethics Committee

Clinical Part

• continuously updated computerized status
    of patient status
    of adverse events
    of monitoring frequency and activities
  facilitates prospective troubleshooting by project management
• controlling of the monitoring :
  reports and reaction on reported problems/questions, adherence of frequency to study visit schedule, recruitment speed and on-site problems
• keeping the study files up to date
• regular monitoring meetings to discuss study progress, general problems occurring and their solution, recruitment speed, time frame etc.
• data query handling
• medical control of data cleaning lists
• management of investigator's fee
• multinational study logistics such as sample transport, drug and material supply (incl. import /export, customs)
• scrip trail track documentation in-house and at investigator sites