Clinical Research:
We'll help you design your study and then run it from first submission to final report.
- Design of clinical research protocols
- Creation of site training programs
- Creation of project schedules and budgets
- Assistance with the selection of clinical research organizations
- Monitoring & Auditing
- Institutional Review Board/Ethics Committee negotiations
- Areas of clinical focus:
- Oncology, Cardiology, Neurology, Rheumatology, Orthopedics, Gynecology, Oral Health, Infectious Disease, and Pediatrics/Neonatology
- Oncology, Cardiology, Neurology, Rheumatology, Orthopedics, Gynecology, Oral Health, Infectious Disease, and Pediatrics/Neonatology
Regulatory:
The earlier you know that the FDA wants, the earlier you know what you need to do. We can plan your regulatory strategy, determine your timelines and present your plan to the FDA.
- Creation of regulatory submissions (513g, 510k, IDE, PMA)
- Meetings with the FDA and other competent authorities
- Creation of regulatory strategies
- Experience with:
- Canada, Australia, New Zealand, China, Singapore, Malaysia, India, Switzerland, UK, Germany, Spain, Italy, Benelux, Japan, Thailand, Republic of Georgia, Brazil, Ireland, France