What is Medical Monitoring in a Clinical Trial? 

Medical monitoring services in clinical trials refer to the supervisory and analytical services provided by a specialised medical professional who oversees the conduct of clinical trials. The primary role of a medical monitor is to ensure the safety and well-being of trial participants and to provide guidance to investigators and study teams regarding the medical aspects of the trial. 

Selecting a Medical Monitor For Your Clinical Trial 

It is important that your study is handled by an experienced medical monitor to safely and efficiently achieve the study end goal. The right medical monitor decision can often avoid costly and avoidable negative impact to your study. An experienced medical monitor would know the different options available during any events within the study.  

Why Choose Our Clinical Trial Medical Monitoring Service?

1. Practising Doctor with Real Patient Care experience

Obatica’s medical monitoring team comprise of practising physicians with specialised training and mostly has extensive experience in clinical research. They may have a background in a specific therapeutic area, such as medical oncology, general physician, geriatrics, surgery, or orthopaedics which will be selected depending on the nature of your  study. Most often we are able to match the right medical monitor to specific study target therapeutic area. In our opinion this is very important specially in complex study such as Oncology.

Our medical monitors all hold an active registration with the Australian Health Practitioner Regulation Agency (AHPRA) to ensure standard of practice and quality.  A health practitioner’s AHPRA registration can be check here.  Medical monitor that understands  standard of care procedures will definitely will be able to provide better advise to different scenarios within the running of clinical trial.  

2. Research and Clinical Trial Experience

It is important that a medical monitor has extensive clinical trial experience so that he/she can provide the best advice during a particular event. Quite often the handling of an event by a medical monitor can greatly affect the end success of the study. Event such as serious adverse event or major protocol deviation would benefit from an experienced medical monitor that understands the regulatory requirements, patient safety limit, and the study end goal. A great medical monitor will be able to identify anomalies, deviations early so the clinical trial study can be back on track.  

3. Comprehensive and Tailored Medical Monitoring Plan

No two clinical trial study is the same. Our medical monitoring team will create a customized monitoring plan together with the sponsor and other stakeholders that will align with the study objective, regulatory standards, and study goals to ensure an optimised clinical trial performance.   

4. Experience in Different Scenarios

It is important that the medical monitor team that you selected already has enough experience to be able to reach accordingly in every medical situations. The medical monitor need to be able provide an additional layer of medical review on top of what the investigators are already providing. If required a healthy discussions between the investigator, sponsor need to be initiated by the medical monitor. Obatica’s medical monitoring team will be able to react accordingly in different medical situations maximising the benefit for patients as well as providing the best chance for the drug to succeed. 

Obatica’s Clinical Trial Experienced Medical Monitors

It is important that your study is handled by an experienced medical monitor to safely support the end study goal. The right medical monitor decisions can sometimes be the difference between the success or failure of the study.

Book in for your free consult here to learn more about our services – Contact us

We understand the critical importance of safety for your clinical trial. We ensure that studies are conducted safely and effectively, and that potential risks to study participants are identified and addressed in a timely manner.

The medical monitoring services offered by Obatica include (but are not limited to): 

• Global study oversight 
• Independent medical monitor 
• Local medical monitor representative
• Study safety monitoring 24/7  
• Medical director oversight and consultation
• Medical writing review for protocol, IB, PICF, and CSR 
• Appointment of medical director for sponsors 
• Safety Review Committe/DSMB chair, voting member, or just participation 
• Lead Principal Investigator 
• Treatment landscape review/disease area and patient population recommendation 
• Regulatory submissions assistance 
• Reviewing and editing clinical trial documents, including statistical analysis plans and interim reports, and 
• Other clinical trial documents required for regulatory approval 
• Study publication 
• Medical writing for abstract and manuscript 
• Support and assistance with conference/journal submission