A medical monitor serves as a reference point for research team members and investigation sites, determining how to evaluate safety incidents in a clinical trial. With this level of responsibility, sponsors can avoid one of the most difficult parts of setting up a trial—finding the right medical monitor—by using an experienced clinical research organizations (CRO) site like veristat.com to consult qualified Veristat professionals. During clinical trials and after a drug is approved, medical monitors make sure that patients are safe and getting the care they need. Having a knowledgeable and experienced medical monitor on board can often make all the difference in how quickly a study is completed.
Why do clinical trials need medical monitors?
Medical monitoring protects participants and data in clinical trials. People usually think of this medical oversight as part of the sponsor team. At Veristat, independent medical monitors (MM) work for the sponsor and oversee multiple study sites or different clinical trials.
Medical monitor expertise
Clinical trial monitors should have a medical degree (MD or PharmD) and good leadership abilities to ensure the well-being of trial participants. Furthermore, most medical monitors have further training in clinical research or the pharmaceutical industry. Medical monitors need medical or even study-specific knowledge to answer queries from investigators, regulatory personnel, study coordinators, and other study team members. Medical monitors teach professionals to study specific indications and help trial participants.
Developing clinical trials
From the start of a clinical trial, a medical monitor is a key part of its development. The medical monitors help make the protocol and make the plans for medical monitoring that will be used to make sure the safety of the participants. They talk to investigators, clinical teams, and site staff to answer questions about drugs that can’t be taken together, medical conditions that can’t be treated, and drugs that aren’t allowed. They also help train the project team on the study protocol’s criteria for who can be in the study and who can’t. With the help of an experienced medical monitor, the time it takes to start a clinical study can be cut down by a lot. Using a clinical research organization that knows how to choose the best medical monitor for research and gives guidance increases the chances of success from the start.
Medical monitors and safety
Medical monitors can help with health and safety emergencies at any time of the day or night. After an adverse event, the medical monitors work closely with the primary investigator to decide if and when the blinding needs to be taken off. When it comes to participants’ health and well-being, it’s up to the medical monitor to evaluate all relevant data to spot any red flags.
Medical monitors are expected to perform their jobs with the understanding that they are essential members of the clinical project team. Typically, they will attend investigator meetings, meetings with the project team, and meetings with the sponsor, and they will make themselves available for queries and concerns.
Medical monitors are typically treated as essential members of the clinical project team. They are available for inquiries and concerns and typically show up to investigator meetings, team meetings, and sponsor meetings.