has a very talented medical team. Our physicians contribute their solid scientific expertise, their medical knowledge and their contacts in the scientific community.
medical monitoring team conducts and reports medical monitoring reviews in a clinical study to ensure that is conducted in compliance with the protocol, SOPs, ICH-GCP, and in accordance with all applicable laws and regulations. They prepare the medical monitoring plan detailing medical monitoring responsibilities and requirements for the study and for overseeing the integrity of data and the safety of the trial subjects.
Our medical monitoring team offers medical expertise to study team, including the following services, among others:
> Medical support for preparing study documents
> Development of Medical Monitoring Plan
> Medical data review
> SAE review
> Continuous medical oversight and medical monitoring of the trial
> Support with medical related issues to ensure patient safety and protocol compliance
> Support sites and study team with questions related to selection criteria and other protocol related doubts
> Provide guidance in questions related to medical conditions
> Process flow and timelines throughout the conduct of the study
> Assistance in pharmacovigilance activities
> Review study reports
