SoCal Clinical Consulting, Inc. is a dynamic, result-driven company, composed of clinical professionals with over 20 years of experience in clinical research. They are adept at strategic planning, domestic and international clinical investigations for regulatory approval of medical devices. Delivering results on time and on budget is our main focus when partnering with our clients.

SoCal Clinical Consulting, Inc. was founded by Bita Ghadimi. Bita’s expertise is in clinical research for PMA and CE Mark approval of medical devices. Bita has worked for many market leaders such as Medtronic, Edwards Lifesciences, Integra Lifesciences, Tandem Diabetes, and numerous other small start-up companies.

Bita has a bachelor's degree in biological sciences and a Master of Sciences in Electrical Engineering.

Services provided

Clinical Trials Consulting

  • Clinical Trial Management
  • Project Management
  • Vendor Management

Training

  • CRO and CRC Training
  • Clinical Staff Training
  • GCP, GDP, FDA, ISO Training

Auditing

  • GCP Audits
  • Vendor Audits
  • Site Audits
  • Sponsor Audits
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Writing

  • Protocol Development
  • Case Report Form Design
  • Study Materials
  • Posters/Abstracts
  • Literature Reviews/Summaries

Regulatory

  • Clinical Evaluation Reports
  • FDA Submissions
  • IRB/EC Submissions
  • Notified Body Submissions

Areas of Expertise

  • Neurovascular Therapies
  • Cardiovascular Therapies
  • Pain Management / Neuromodulation
  • Diabetes
  • Interventional Cardiology
  • Vascular
  • Critical Care
  • Orthopedic Therapies
  • Emphysema

Clinical Study Expertise

  • Regulatory (PMA Approval, CE Approval)
  • Domestic
  • International
  • Registries
  • Post-Market
  • Compassionate Use
  • Class II & Class III Devices