Service List
Clinical Trail and research involve Phase 1 to Phase 3, the entire journey process relies on the expertise of a medical monitor to oversee the safety aspects.
Medical monitors ensure the safety and integrity of the trial subjects throughout the trial, from the initial design of the study to the final closeout.
A medical monitor acts as the point of reference for study team members and investigative sites and determines how to evaluate safety events within a clinical trial.
With this high level of responsibility, North Quest Solutions will help to hire skilled personnel find the right medical monitor and relieves sponsors of one of the most challenging aspects of setting up a trial.
Medical Monitor Expertise
Medical monitors must have a Medical degree and strong leadership skills to monitor the safety. In addition, most medical monitors have specialized training related to clinical research and the pharmaceutical industry.
Since medical monitors answer questions from investigators, study coordinators, regulatory personnel, and other clinical study team members, they need medication and study-specific knowledge. Medical monitors not only train staff in how study specific indications, but they also keep up with the subject participates of the trial to offer support and guidance.
Developing Clinical Trials
The medical monitor plays a crucial role in its development.
Medical monitors are the pillar to all the key functions in clinical research development includes
Pharmacovigilance
Medical Writer
Clinical Operations
Data Management
Statistics
Pharmacovigilance
- Medical monitors provide round-the-clock emergency coverage on all safety-related matters. If an adverse event occurs, medical monitors determine how to code those events and work closely with the principal investigator whether unblinding is required.
- To review all safety-related data to track participants health and monitor for any potential issues.
Medical Writer
- Right from the Study design, Protocol development till the generation of Clinical Study Report
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Clinical Operation
- Training of the project team on the trial Protocol
- Eligibility Checklist includes the data on Inclusion and Exclusion Criteria
- Clinical site teams to assist with questions on medical conditions, concomitant drugs and prohibited drugs.
- Addressing safety issues across the study from sites and the study team
- Actively interacting with investigative sites
Data Management
- Review of eCRF, auto queries, Lab abnormalities
- Review of line listings data and also for coded events to verify Medical Dictionary for Regulatory Activities (MedDRA) consistency
Statistics
- Review of Statistical Analysis Plan and input on the same
- Review of Table Listing and Figure before the start of Clinical Study Report
Summary
Medical monitors work under the expectation that they are part of the core clinical project team. Typically, they attend investigator meetings, project team and sponsor meetings and keep themselves available for questions and concerns.
North Quest Solutions supports both medical monitors and staff to ensure that no questions or concerns go unanswered. Through set processes and solutions and uniquely qualified medical monitors, clinical trials go smoothly and efficiently.
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Frequently Asked Questions (FAQs)
How can outsourcing accounting services benefit my business?
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