65

CRA Services


Experience
Nursing background and 11 years of clinical research experience. Responsibilities in Clinical Research included study start up activities, monitoring visits (pre study site, initiation, close out), delivery of GCP trainings, submission to regulatory body, submission to ethic committees, query resolution, drug accountability & re-labeling, management of SAEs, inspections.

Regulatory and Clinical
  • Protocol development & Medical writing.
  • Informed consent adaptation and Patient documents preparation.
  • Labeling.
  • Feasibility visits s and site selection.
  • IRB submission.
  • Budget and contract negotiation.
  • Study initiation.
  • On-site monitor and regulatory training.
  • Drug accountability.
  • Queries tracking and resolution. 
  • Study closeout procedures. 
Therapeutic Areas
  • Auto-Immune Diseases: Ulcerative colitis, multiple
    sclerosis.  
  • Central Nervous System Disorders: Parkinson disease.
  • Oncology: Lung, Colon, Colo-rectal, Breast.
  • Cardiovascular Diseases: Coronary artery bypass graft surgery (CABG) Follow up, Acute coronary events.
  • Medical Devices: Stents, Thermoregulation system.
  • Ophthalmology: Macular degeneration, ischemic optic neuropathy.
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