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
Need any help?
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.
Book Your Free Consultation Call
Frequently Asked Questions (FAQs)
How can outsourcing accounting services benefit my business?
Outsourcing accounting services provides cost savings, access to expert financial knowledge, accurate record-keeping, and compliance assurance, allowing you to focus on business growth.
What accounting tasks can be outsourced to North Quest Solutions?
We offer a wide range of accounting services, including bookkeeping, financial reporting, payroll processing, tax preparation, and more.
Is my business too small for outsourced accounting services?
No business is too small for our services. We cater to businesses of all sizes, providing customized solutions that fit your specific needs and budget.
How can your accounting team help with tax preparation?
Our expert accountants are well-versed in tax regulations and can assist in preparing accurate and timely tax returns, maximizing your tax benefits.
Can I rely on your accounting services for confidential financial information?
Absolutely! At North Quest Solutions, we prioritize the security and confidentiality of your financial data. Our systems and processes are designed to protect your information from unauthorized access.
Choose North Quest Solutions today and experience the power of efficient and reliable accounting services. Our expert team is dedicated to helping your business thrive by providing top-tier financial solutions tailored to your needs. Let us be your financial allies on the path to success.