Project Management and Clinical Monitoring

Since our foundation in 2005 we have successfully managed more than 240 trials in various therapeutic areas.

At OCT, a Project Manager (PM) is assigned for each project. OCT PMs’ educational backgrounds range from biologists to MDs. Our project managers have at least five years of clinical experience.

Before the start of each project, PMs ensure that the study team can work efficiently to meet project objectives. PMs work closely with regulatory, clinical, quality assurance, medical writing, data management, safety departments and vendors. Together with the study team, OCT PMs write comprehensive execution plans upfront so that the study team can manage the clinical trial to the required timelines, within study budget and while maintaining high quality.

project management

The PM prepares a Monitoring Plan, a final draft of which is provided to the Sponsor for review and comment by the Sponsor internal study team members ahead of the first-patient-first-visit date The monitoring schedule, which is a part of the Monitoring Plan, is based on a continuous risk assessment approach and adjusted for the project needs at the study start-up as agreed upon with the Sponsor. By monitoring available data off-site or centrally, on-site monitoring is targeted to activities that cannot be performed remotely. We use a risk-based monitoring approach that is based on the FDA recommendations and guidelines for monitoring.

During on-site monitoring visits, OCT CRAs perform the following tasks to monitor compliance with GCP and local regulations:

  • Perform 100% review of all signed ICFs
  • Review and verify 100% of available source documentation
  • Review all clinical data at the site for legibility, completeness, and consistency within the protocol
  • Train site personnel as required
  • All monitoring visits are documented in a monitoring visit report and follow-up letter to the site.

OCT PMs are also responsible for study specific and standard operating procedures training for the OCT study team. Throughout the study, Project Managers control communication with study team by means of team meetings, internal teleconferences, periodic status reporting and e-mail updates.

OCT is able to provide our clients with a hands-off approach. OCT Project Managers work proactively to predict problems, analyze trends and develop options for solutions and make recommendations. Sponsor can step back and allow OCT to implement their study on the ground.