Our company specializing in hyperbaric and hypobaric engineering has just been awarded by the Regional Health Agency, accreditation authorizing it to practice clinical research involving the human person within our premises.
What is biomedical research?
Field of study that aims to improve knowledge about health. To do this, it is based in particular on the collection, with volunteer subjects, of biological and / or medical information.
Biomedical research relies on a step-by-step process, from conception to analysis of results. In order to ensure maximum security for subjects, researches are strictly regulated by law in France:
- They are studied and conducted by multidisciplinary teams of qualified people (doctors, technicians, statisticians, nurses …).
- These teams work according to an established protocol.
- Authorities control researches (National Agency for the Safety of Medicines and Health Products or ANSM, Committee for the Protection of Persons or CPP).
- Throughout a research, committees generally monitor its progress.
This biomedical research accreditation concerns two locations at Comex premices.
1) Hyperbaric and Hypobaric Test Center
• Dedicated test facilities (altitude simulator and dive simulator)
• A medical consultation room
• Real-time video and audio monitoring system: to ensure the inside and outside interface of the hypobaric chamber
• A medical oxygenation device available without delay inside / outside the chamber
• A DAD defibrillator + emergency cart
• Resuscitation equipment within the immediate vicinity of the chamber
• Medical monitoring and control devices of the subjects
2) The test pools
The studies will apply to healthy subjects aged 18 to 65 and will focus on physiological topics only.
The medical assistance will be provided by the Institute of Physiology and Medicine in the Maritime Environment and Extreme Environments “PHYMAREX” which brings together a team of doctors and nurses coming mainly from the Public Assistance of Marseille Hospitals (APHM) and more precisely from the Hyperbaric Center of Sainte Marguerite University Hospital. They are trained in hyperbaric medicine and / or emergency medicine and / or aeronautical and aerospace medicine.
They will work under the supervision of Dr. Mathieu COULANGE, Md an emergency doctor specialized in hyperbaric medicine, maritime medicine and aeronautical medicine. Dr COULANGE is Head of Sainte Marguerite University Hospital department for hyperbaric, underwater and maritime medicine.
“We are pleased with this approval because it mainly concerns hospitals. It is seldom attributed to private companies. However, this approval is not new to COMEX who worked with it for the development of manned deep dives under hydrogen and helium mixes during the 80’s and 90’s.