Acting as a bridge between Sponsor and Vendor
As a Sponsor Medical Monitor and Medical - Safety Advisor
It is key in Clinical trial management that the synopsis, and protocols written by vendor are aligned with the sponsor need to maintain the integrity of the data. This is essential in order to ensure that the clinical trial is conducted ethically, safely and in accordance with regulations and good clinical practice (GCP). It is also important to ensure that the trial objectives are met and results are reliable. The synopsis and protocols must be reviewed and approved by the sponsor prior to initiation of the trial to ensure that all components are in alignment with the sponsor need. Additionally, any changes to the protocols throughout the trial must be approved by the sponsor to ensure that the trial is conducted as originally envisioned.
Act as the primary point of contact between the sponsor and vendor, communicating expectations and concerns.
Ensure that the vendor fully understands the study protocol, endpoints, and regulatory requirements.
Oversee the safety and medical aspects of the clinical trial, including adverse event reporting and data review.
Provide medical and scientific expertise to ensure that the study is conducted in accordance with ethical and regulatory standards.
Monitor the quality of data generated by the vendor, and provide feedback for improvement as needed.
Encourage open communication between the sponsor and vendor, resolving issues and ensuring that priorities are aligned.
Ensure that the vendor has the necessary resources and support to perform effectively, including training and technology.
Regularly review progress and assess the performance of the vendor, addressing any issues in a timely manner.
Represent the sponsor in interactions with regulatory authorities and other stakeholders.
Ensure that the sponsor is kept informed of all relevant developments and issues related to the clinical trial.
