Why Choose CSI?

MEDICAL DEVICE EXPERIENCE

In today’s global market, successful market entry can be very challenging, confusing and costly for companies who are attempting to obtain regulatory approval for a new device or technology.  Most companies cannot provide the expertise and experience that teaming with an experienced and motivated CRO clinical and regulatory staff can offer. Clinical Solutions International (CSI) provides these advantages and looks for the most cost effective pathway for market entry before it suggests which route its clients should take. Regulatory authorities have a prime concern of providing patient safety and ensuring the public welfare. CSI has the experience to ensure that these goals are met and that authorization to market is achieved.  We have the first-hand experience to provide the following answers to our clients:

1. Has the client addressed the risk analysis adequately?

2. Is the information supplied in the technical file adequate for EU market entry?

3. Will it be necessary or advisable to conduct a clinical investigation?

4. Will information gained from an in-depth literature search provide the required clinical data?

5. For the US market, is a 510(k) justifiable?

6. Can an acceptable predicate device be identified?

7. Will a pilot or feasibility study be advisable?

8. What endpoints will require the smallest sample size?

9. How does ISO 14155, 21 CFR 812 and CFR Part 11 effect the requirements for market entry?

What does the FDA require for overseas data to be acceptable?

10.   

CSI specializes in obtaining authorization to market within the global community. Our company has expertise in the EU, Asia, US, UK, Canada, Australia, Japan, and many other countries.  We pride ourselves in the fact that we can serve our customers' needs and address market entry and regulatory issues; all the while developing creative ways to provide a cost effective and successful pathway into the medical device market.

CSI supplies its clients with the experience and understanding of global regulations that govern successful entry into the medical device market place. Whether they apply to FDA CDRH, MHRA, TGA or any other national requirements, CSI has the experience to provide the necessary approach to meet the required regulations. By teaming with CSI, our clients realize the advantages that most other CROs can not provide. Our staff is composed of clinically experienced professionals who understand the necessity of cost savings, a unified approach, statistical validity, and a timely market entry. You are not only our client, but your success is our company’s prime objective.

CLINICAL SERVICES

• Clinical Investigation design and management

• Clinical User Evaluations

• Feasibility or Pilot Studies

• Clinical Data Reviews (literature reviews)

• Protocol design and development

• Principle Investigator and Study Site identification

• IRB and Ethics Committee interaction

• Preparation of Investigators contracts, brochures, and instructions for Use

• Clinical Research Submissions (FDA, MHRA, TGA, and many others)

• Organize Investigator Meetings

• Provide focus groups, advisory boards, risk reviews and physician directed adverse event reviews

• Clinical Project management

• Data Management

• Statistical data analysis

• Site Visits (initiation, monitoring, and close-out)

• Technical and Final Report writing

• US Agent Service

MARKET RESEARCH

• Competitive Market Research

• Market Analysis

• On-line Studies

• Telephone interviews

• Surveys

• Convention Research

• Focus Groups

• Customer Profiling

NEW IDEAS and INVENTIONS

• Medical Device Brokerage

• Market Assessment

• Patent Searches

• Patent Drawings

• Prospectus Development

• Prototype Manufacturing

• Manufacturing partner identification

• Business Agreements

• Sale and Licensing Negotiations