Project Management and Clinical Monitoring
Since our founding in 2005 we have successfully managed more than 270 trials in various therapeutic areas. A significant role in the successful implementation of projects is played by responsive control from managers team, each of whom has more than five years of clinical experience.
Both OCT’s project managers as well as clinical trial monitors are certified doctors, pharmacists, or chemists. When monitoring, we take a risk-based approach, and if necessary turn to remote monitoring of the study site activities.
- Preparation of detailed work plans
- Preparation of a Monitoring Plan
- Organization of training for the project team in accordance with Standard Operating Procedures and specific elements of the trial
- Keep the project team informed on an ongoing basis about the progress of the study
- Preparation of activity reports
There are two types of monitoring procedures: on-site and remote. The monitoring schedule, which is a part of the Monitoring Plan, is based on a continuous risk assessment approach and is adjusted for the project’s needs at the study start-up as agreed upon with the Sponsor. On-site monitoring is targeted at activities that cannot be performed remotely.
- Perform review of all signed ICFs
- Review and verify available source documentation
- Review all clinical data at the site for legibility, completeness, and consistency with the protocol
- Conduct training of site personnel as required
- Document all monitoring visits in the report and submit a follow-up letter to the site
The Sponsor can fully rely on OCT for conducting a successful clinical trial from “a” to “z”. Our project managers will, in a timely manner, prepare a prognosis of possible problems and risks, they will analyze the tendencies and give recommendations as well as prepare options to resolve the problems. The Sponsor determines their degree of involvement in the project, and our team of specialists will take all the tasks and responsibilities of conducting a clinical trial upon themselves.