Clinical Study Management

Our project management team is the key of our success. Exceptionally qualified project managers are assigned to your project and act as the primary contact between you and the study team. Together you define project's timelines, quality targets and budget so that they will provide excellent leadership and direction to the project team. At the same time they focus on their main responsibility which is to act proactively and reactively in order to ensure that any potential obstacles will not affect study deliverables.

They are very well experienced to oversee all types and phases of clinical research, from experimental to observational studies and from early Phase I trials to large multi-center Phase III and Phase IV post marketing studies. Through planning, timely implementation and punctual performance of all project responsibilities, combined with time-tested tracking and reporting systems, we possess an impressive track record of completing projects on time, on budget and on target.

Our Clinical Trial Management Services include the following:

  • Clinical Development Plans
  • Phase I, II, III, IV, Post-Marketing and Safety Surveillance Trials
  • Epidemiological/Market Research Studies
  • Study Protocol, Informed Consent and Case Report Form Design
  • Site/Investigator Identification
  • Pre-study Site Assessment and Selection
  • IRB and Regulatory Authority Approvals and Reporting
  • Preparation of Training Materials/Site Training
  • Site Initiation, Monitoring, and Close-out Activities
  • Clinical and non-Clinical Supplies Logistics and Inventory Development
  • Patient Recruitment Strategies
  • Study Auditing
  • Archiving of Clinical Trial Materials
  • Organization of Investigator Meetings

 

How can we help you?