Clinical Trials and Real World Evidence
The Clinical department assists you in setting up your studies: pre- and post-market studies from the protocol to the Clinical Study Report (CSR).
Our team of Medical Writers is able to help you in the completion of the technical documentation or to support the clients on specific needs amongst the following documents :
Clinical Evaluation Management : CEP and CER
- Scientific litterature search, based on objective key-words, systematic and unbiased
- Data Analysis and Evaluation
Post-Market Clinical Follow-up (PMCF) : Planing and evaluation Report
Summary of Safety and Clinical Performance (SSCP)
Periodic Safety Updates Report (PSUR)
The different steps of a Clinical Evaluation
Focus on the heart failure, acute coronary syndrome, interventional cardiology
Supportive care, diagnosis, interventional radiology and some specific treatments as nanoparticules or cements and tools to improve patients quality of life
Dental health products such as restorative materials, orthodontic appliances, surgical equipment, implantologies, cements, liners, adhesives...
Reconstructive joint replacements, cardiac pacemakers, defibrillators, stents, valves, electrical leads/ batteries, tissue-engineered constructs and drug delivery systems
Minimally invasive treatments using radiologic imaging for procedure guidance. These treatments or diagnoses are offering less risk, less pain and less recovery time, compared to open surgery
Both surgical and nonsurgical approaches to treat a variety of musculoskeletal issues, such as sports injuries, joint pain, and back problems
Continuous Glucose Monitoring device, management of "diabetic foot"
Focus on supportive care for the pediatric population in different therapeutic areas, mainly heart failure and interventional cardiology and this including neonatal and premature newborns
Central Nervous System (CNS) focuses on strokes and neurovacular diseases, to improve the patients care