Choose a CRO Partner Who Understands Your Unique Development World.
Whether you're investigating an apparatus, instrument, machine or other type of device, our Medical Device Business Unit knows your success hinges upon highly specialized regulatory, reimbursement programs, safety and marketing support. Operating on high-quality systems, we can prepare those key documents that will ultimately clear your product for marketplace entry.
Even after your commercial launch, we're here to help propel your device to that next level. From developing a reimbursement strategy to meeting post-marketing surveillance requirements, we offer the added value of a long-term relationship that endures throughout every phase of your device's lifecycle.
Consider the advantages:
Diverse Service Offering. We handle all risk classifications and approval pathways, as well as In Vitro Diagnostic (IVDs) and Combination Devices, through Feasibility, Pivotal and Continued Access Studies, and can support your project in the following areas:
- Regulatory Clearance/Approval
- Clinical Design & Clinical Trial Conduct
- Compliance
- Reimbursement Strategy
- Global Surveillance
- Data Safety Monitoring Board/Clinical Events Committee
Strong Experience History. We've conducted numerous Medical Device studies across a variety of therapeutic areas:
- Cardiovascular. AAA (abdominal aortic aneurysms), arteriovenous grafts, atrial septal defect, catheterization procedure/puncture site closure, cardiovascular intervention, coronary artery lesions, coronary disease, restenosis, septal occluder, stent, thoracic aortic aneurysms, traumatic transection of the descending thoracic aorta.
- CNS. Alzheimer's disease, multiple sclerosis, pain management, Parkinson's disease, stroke.
- Dental Medicine. Dental devices.
- Dermatology. Atopic dermatitis, sun damage, urticario, wound healing.
- Endocrinology. Diabetes, diabetic foot ulcers, obesity.
- Immunology/Infectious Disease. Herpes simplex, immunization, osteoarthritis, sepsis, systemic lupus erythematosus.
- Nephrology/Urology. Chronic renal failure.
- Oncology. Lung cancer, metastatic melanoma.
- Ophthalmology. Contact lubricant, dry eye, LASIK retractive surgery.
- Pulmonary/Respiratory. Asthma, chronic obstructive pulmonary disease, exposure to cigarette smoke.
- Surgery/General.
Combination Market Expertise. Because we are a CRO with business units dedicated to the drug development market, we can leverage that pharmaceutical expertise to successfully meet your combination device needs.
Product Life Cycle Optimization. The development process shouldn't end once your device is cleared by the appropriate authorities.