Medical Monitoring
Throughout your clinical trial, your key priorities will be to protect patient safety and to ensure complete compliance with protocols. We can help you do both.
Make sure your study meets its objectives
With 25 years of industry experience, ESMS understands the factors that are crucial to the success of your clinical study. We’ve built a network of Medical Doctors, with backgrounds in clinical research and medical practise, to provide you with expert support at every stage.
Each of our Medical Monitors has an in-depth understanding of clinical protocols and safety, enabling them to provide a truly valuable service to your investigative sites and teams. They are also supported by the ESMS 24/7 Emergency Medical Response Service.
Support at every stage
Before Your Clinical Trial
- Study design consultation
- Medical Monitoring plan
- Key document review
- Training for project teams
Before your trial commences, we can provide a consultation service on the design of the study. Once responsibilities are set out, we will supply you with a medical monitoring plan
and reporting templates, to agreed specifications.
We can review your Protocol document, Investigator’s Brochure (IB) and Informed Consent (ICF) elements to ensure all regulatory requirements are met, We can also contribute to all study documentation as required by you. If your therapy area project teams require training, we can undertake this on your behalf, and we’ll also be on-hand at your Investigator meeting, to help ensure excellent communication from the outset.
During your clinical trial
- Patient data review
- Support with narrative and regulatory reporting
- Safety data review
- Ongoing liaison with your teams
Once your trial begins, we can support you by conducting a full medical review of patient data against your study’s inclusion criteria.
As you progress, we can also review all adverse event (AE) and serious adverse event (SAE) data, assessing causality to an investigational medicinal product (IMP) or device, and will contribute to the writing of narratives and regulatory reports as required.
We have the knowledge and experience to conduct reviews of safety data from each of your cohorts and to contribute to meetings where appropriate. Most importantly, we will maintain ongoing communication with your own monitoring and pharmacovigilance (PV) teams.
At clinical study report (CSR) stage
- Blinded data review
- Support to define data deviators
- Drafting of case narratives
- Complete CSR review
When the time comes to create your clinical study report, we’ll continue to support you and your teams in bringing everything together.
Our Medical Monitors can plan and conduct your blinded data review meeting and deviators definition meeting, and can also contribute to your final report by drafting case narratives as required.
To help you ensure you have everything covered, we’ll also provide a complete and comprehensive review of your CSR before final publication.
Enquiry Form
Complete our enquiry form today, or email us at info@esmsglobal.com to find out how we can support your next study.
ESMS 24/7 Emergency Medical Response Service
When you choose ESMS for Medical Monitoring, we’ll provide every investigator site and Medical Monitor working on your study with ongoing medical support, all day and every day.
This service is available across 80 countries and in 40 different languages, with dedicated, low-rate telephone numbers for all countries in the study.
‘A centre of excellence… providing a superior service’
Medicines and Healthcare products Regulatory Agency (MHRA)
