Smooth Drug Development provides services of medical monitoring in clinical trials.
Medical monitoring – is an expert medical support of the development of a pharmaceutical product at all stages of the clinical research. Medical monitor of a study is a professional in the study nosology, which has considerable experience both in therapeutic practice and clinical trials.
GCP requires the Sponsor and CRO to "designate appropriately qualified medical personnel who will be readily available to advise on trial-related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose."
Our company has business relationship with a number of highly qualified specialists from different therapeutic areas. In all studies we allocate a medical monitor with relevant experience.
Medical monitoring is performed in accordance with the Medical monitoring plan, which describes all the activities performed in this study, such as eligibility review of study subjects, criteria for early discontinuation, procedure of safety evaluation, terms of review of serious adverse event and unexpected reaction reports (SAE and SUSAR), deviation criteria, procedure of listing review, criteria of study populations review and other.
If necessary, we organize a Data and Safety Monitoring Board (DSMB), which performs intermediate data assessment and make recommendations on the continuation of the study, or changes in the study documents.
Functions of Medical Monitor:
During preparation to the study
- Participation in the definition of study nosology and patient population
- Participation in the development of study hypotheses
- Defining the criteria of efficiency and safety
- Participation in the development of study documents
- Development of Medical monitoring plan
- Training for study team on the nosology
- Risk assessment to reduce screen failure and protocol deviations rates
- Participation in Data and Safety Monitoring Board
During the study
- Evaluation of subject's eligibility
- Evaluation of safety data to open recruitment to the next cohort
- Consulting support for investigators 24/7
- Assessment of the significance of deviations from protocol
- Assessment of the need for early discontinuation of subjects
- Evaluation of SAEs for their expectedness and relationship to the study drug
- Participation in the preparation of contingency SADR reports
- Check listings for safety and health data
- Participation in preparation of regular safety reports
- Participation in updating of the study documents
After clinical phase
- Determination of study populations
- Evaluation of the results of the statistical analysis
- Participation in preparation of the conclusions of the study
- Participation in preparation of the Final study report