Medical Device

When you need the leading experts in complex medical devices, THINK THEOREM.
 
Few if any CROs our size have the depth of experience in medical devices that Theorem Clinical Research does — and few qualities are a better indicator of success for your next trial than experience.
 
Over the last two decades, our medical device study team has managed hundreds of complex studies for all classes of medical devices. In addition to our experience in primary devices for orthopedic, oncologic and cardiovascular indications, think Theorem for implantable devices including drug-coated or drug-eluting stents and device-based drug delivery mechanisms.
 
We have the development and regulatory expertise to execute successful medical device trials across all risk classifications and approval pathways globally. Once your device is cleared for market entry, Theorem’s regulatory and health economics experts will develop adjunctive reimbursement and safety surveillance programs, and provide ongoing marketing support.

  • Broad therapeutic expertise
  • All risk classifications and approval pathways
  • Specialized expertise in drug-eluting and drug-device delivery systems
  • Pilot, pivotal and post-surveillance studies

Services

  • Protocol Development
  • Clinical Studies
    • First-in-Human
    • Feasibility
    • Pivotal
    • Continued Access
  • Regulatory Consulting
  • Adjunctive Reimbursement Programs
  • Safety Surveillance/Observational Programs

Experience

  • Cardiovascular
    • Abdominal Aortic Aneurysms
    • Arteriovenous Grafts
    • Atrial Septal Defect
    • Catheterization Puncture Site Closure
    • Coronary Artery Lesions
    • Coronary Disease
    • Peripheral Arterial Disease
    • Restenosis
    • Septal Occluder
    • Stent
    • Thoracic Aortic Aneurysms
  • CNS
    • Alzheimer’s Disease
    • Multiple Sclerosis
    • Pain Management
    • Parkinson’s Disease
    • Stroke
  • Dental Medicine
  • Dermatology
    • Atopic Dermatitis
    • Fillers
    • Psoriasis
    • Sun Damage
    • Urticaria
    • Wound Healing
  • Endocrinology
    • Diabetes
    • Diabetic Foot Ulcers
    • Obesity
  • Gastroenterology
    • Barrett's Esophagus
    • GERD
  • Immunology
    • Hepatitis C
    • Herpes Simplex
    • Immunization
    • Sepsis
    • System Lupus Erythematosus
  • Musculoskeletal
    • Orthopedic
    • Osteoarthritis
    • Spinal Disease
  • Nephrology
    • Chronic Renal Failure
    • Portal Hypertension
  • Oncology
    • Hepatocellular Carcinoma
    • Lung Cancer
    • Metastatic Melanoma
  • Ophthalmology
    • Contact Lubricant
    • Corneal Allograft Rejection
    • Dry Eye
    • LASIK Refractive Surgery
  • Pulmonary
    • Asthma
    • COPD
    • Exposure to Cigarette Smoke
  • Surgery