Projets déjà réalisés ou en cours

CTI Consulting

  • - Kidney Transplantation living donor, phase II – 4 sites – 38 patients. Alexion.
  • - Kidney Transplantation Decease donor, Phase II – 4 sites – 29 Patients. Alexion.
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CNIL, CNOM submission in France. Monitoring to close out visit.

SynteractHCR

  • - Cardiology, Phase III – European Ambulance Acute Coronary Syndrome – 8 Sites – 52 Patients. The medicines Company
  • - Delayed Graft Function – Nephrology, Phase III – 5 sites – 23 Patients. Quark.
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CNIL, CNOM submission in France. Monitoring to close out visit.

ClinServ

  • - Dermatology, Phase IV – Psoriasis mild to moderate, Therapeutic education – 20 Sites – 250 Patients – CRA – Lead CRA and Project manager. SCIDerm.
  • - Infectiology, Antibiotherapy, Phase I - Novartis.
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CCTIRS, CNOM submission in France. Monitoring to close out visit.

Paragon Biomedical

  • - Dermatology, Phase III – Psoriasis moderate to severe – 5 Sites – 73 Patients – CRA. Abbott.
  • - Gastro-enterology, Phase II – Crohn disease – 3 sites – 7 Patients – Pediatric Study. Abbott
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CNIL, CNOM submission in France. Monitoring to close out visit.

ICON

  • - Oncology, Phase II – Breast cancer – 6 Sites – 27 Patients. Lilly
  • - Oncology, Phase II – Non small cell lung cancer – 5 sites – 17 Patients. Lilly
  • - Monitoring to close out visit.

Novella

  • - Diabetology, Phase III – 4 Sites – 52 Patients. LifeSan, Johnson and johnson
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CCTIRS, CNOM submission in France. Monitoring to close out visit.

Cochlear

  • - Hearing implant – 7 Sites – 16 Patients
  • - Clinical trial SOP writting – GCP training
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CNIL, CNOM submission in France. Monitoring to close out visit.

GSK

  • - Oncology, Phase II – Breast cancer – 3 Sites – 23 Patients
  • - Oncology, Phase II – Metastatic cervical cancer – 2 sites – 9 patients
  • - Neurology, Alzheimer disease – 3 sites – 24 Patients.
  • - Contract negotiation with involved study sites in France.
  • - Monitoring to close out visit.

Biotrial

  • - Oncology, Phase II – Leukemia – 3 Sites – 12 Patients
  • - Oncology, Phase I – Metastatic cervical cancer, breast cancer, lymphoma
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CNIL, CNOM submission in France. Monitoring to close out visit.

MAPI

  • - Rheumatoid arthritis Phase III– 5 Sites – 21 Patients. UCB
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CNIL, CNOM submission in France. Monitoring to close out visit.

Novonordisk

  • - Hematology, anesthesia post-operative bleeding– 2 Sites – 15 Patients
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CNIL, CNOM submission in France. Monitoring to close out visit.

Barrington James

  • - Cardiology – Medical device – Aortic valve implant, Phase III – 5 sites – 23 patients. Edwards Lifesciences
  • - Dermatology – Phase IV – Psoriasis – Lead CRA Europe. Galderma
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CCTIRS, CNIL, CNOM submission in France. Monitoring to close out visit.

PRN Pharmaceutical

  • - Ophtalmology –Phase II – 5 sites – 18 patients.
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CCTIRS, CNOM submission in France. Monitoring to close out visit.

Baxter

  • - Dialysis –Phase IV – 22 sites – 153 patients.
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CCTIRS, CNIL, CNOM submission in France. Monitoring to close out visit.

Innopharma

  • - Mastocystosis –Phase III – 2 sites – 21 patients. AB Sciences.
  • - Monitoring visit.
  • - Supra refractory epilecticus –Phase III – 4 sites – 4 patients. SAGE pharmaceuticals. (ICU)
  • - Contract negotiation with involved study sites in France.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CCTIRS, CNOM submission in France. Monitoring to close out visit.

Axonal

  • - Epidermoid carcinoma - Observational Study
  • - eCRF completion

Fresenius Medical care

  • - Dialysis –Medical device study – 1 site – 6 patients.
  • - Study submission to competent authority (CA) and Ethics committee (IEC), CCTIRS, CNOM submission in France. Monitoring to close out visit.

Micron

  • - Pneumonia caused by Staphylococcus aureus–Phase II – 6 sites – 6 patients. ARIDIS (ICU)
  • - Interim Monitoring to close out visit.