Management of an international Phase IV study in Diabetes - (March 2016, Present) - 7 Countries – 230 Patients
Management of an international NPP in Oncology - (June 2015, Present) - 38 Countries – 1100 Patients
Management of an international Phase IV study in multiple sclerosis (January 2014, Present) - 14 Countries – 1000 Patients
Management of an international named patient program in oncology (November 2012, Present) - 25 Countries – 750 Patients
Management of a product registry in diabetes (November 2012, January 2014) - 10 Countries – 3100 Patients
RFPs, Budget/AED, feasibility, vendors’ selection
Coordination of contracts research organization, interactions with vendors, set-up and follow-up activities (Data Management and Statistics, Central Lab, IRT)
Coordination and support of field-monitoring activities through regular meetings: teleconferences, CSU/CTT, preparation and review study documents
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in healthcare, with 6 growth platforms: emerging markets, vaccines, consumer healthcare, diabetes treatments, innovative products and animal health. Through the acquisition of Genzyme, Sanofi has strongly reinforced its footprint in rare diseases.
Operational planning and activities for the implementation and conduct of an international phase III study on multiple sclerosis
Data management
Coordination of a clinical research organization, interactions with vendors and follow-up activities (Central Lab)
Coordination and support field-monitoring activities through regular meetings: teleconferences, CSU/CTT, preparation and review of monitoring plan, communication plan.
Data Review and Surveillance, Medical review
Validation Listing Specification
Internal Training: Data Management, Statistics Basics, Data Review, Cleaning & Surveillance
Lille Clinical Investigation Centre for Innovative Technology (CIC-IT) was created by the Ministry of Health (DHOS) and the INSERM in 2008. It is dedicated to eHealth and entitled "Bio-capteurs et e-Santé : innovation et usages" (Biosensors and eHealth: Innovation and Uses). Thanks to its integration into Lille Hospital Campus, it has easy access to the Hospital and University platforms. The CIC-IT is strategically situated on Eurasanté business park. It rests on a strong partnership with Lille multi-topic CIC and the public health hospital and university research teams.
Lille CIC-IT gathers pluridisciplinary skills in computing, signal processing, ergonomics, human factors and Man-Machine Interfaces.
Clinical trials management of national phase II/III studies on a medical device analyzing the autonomic nervous system activity through ECG in neonatology intensive care unit (Newborn Infant Parasympathetic Evaluation)
Recording of patients’ data on site and CRF completion
Data treatment
Statistical analysis
Interactions with healthcare professionals and patients
Clinical Investigation Centre for Innovative Technology
February 2010
to April 2010
Internship
Lille
France
Lille Clinical Investigation Centre for Innovative Technology (CIC-IT) was created by the Ministry of Health (DHOS) and the INSERM in 2008. It is dedicated to eHealth and entitled "Bio-capteurs et e-Santé : innovation et usages" (Biosensors and eHealth: Innovation and Uses). Thanks to its integration into Lille Hospital Campus, it has easy access to the Hospital and University platforms. The CIC-IT is strategically situated on Eurasanté business park. It rests on a strong partnership with Lille multi-topic CIC and the public health hospital and university research teams.
Lille CIC-IT gathers pluridisciplinary skills in computing, signal processing, ergonomics, human factors and Man-Machine Interfaces.
Validation of a device analyzing the autonomic nervous system activity for pain measurement during general anaesthesia.
