Interventional studies
A LITTLE HISTORY
History records that the first therapeutic trial took place on board the ship HMS Salisbury. James Lind, a Scottish doctor working in the Royal Navy, organized on May 20, 1747 a therapeutic experimentation to fight scurvy. 12 sailors were divided into 6 groups, each of which received a different treatment: a quart of cider per day, a bowl of sea water per day, 2 oranges and 2 lemons per day, a vitriol elixir 3 times a day, a spice decoction twice a day and 2 spoons of vinegar per day. James Lind noted that the two sailors who had taken the oranges and lemons healed and became stretcher bearers for the other sailors whose condition was getting worse. In 1753, he published a treatise on scurvy, A Treatise of the Scurvy, but it was not until 1795 that the Royal Navy made the use of lemons on board mandatory!
KAPPA SANTÉ'S EXPERTISE
Kappa Santé conducts randomized and non-randomized intervention studies in various fields ranging from phase 3 therapeutic trials to evaluations of patient management strategies. These studies use specific methodologies and concern
- Biomedical research on human beings for the purpose of acquiring biological or medical knowledge such as therapeutic trials, medical device studies or pathophysiological studies.
- Research in routine care
Intervention can be defined as any diagnostic or monitoring procedure performed on the person that is not justified by the medical management of the person.
Kappa Santé offers the following services for interventional studies:
- Choice of study design
- Writing the protocol and CRFs
- Regulatory procedures
- Selection of investigators and feasibility study
- Investigator training
- Trial management and clinical operations
- Monitoring
- Data management and biometrics
- Pharmacovigilance management
- Report writing and scientific exploitation
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