Clinical Evaluations and Investigation Reviews

In Europe, the Notified Body will expect to see a clinical evaluation of the device. This may come from a detailed, objective literature review or de novo clinical data or a mixture of both. In the US, a thorough literature review is needed to justify the use of a predicate device in any submission to the FDA. CSI performs these literature reviews to the required standards. Feedback to date from clients and NBs is that these reviews are excellent and have achieved success for our clients.

Study Design

We work diligently with our clients to produce a study design meeting all regulatory, commercial and technical needs. Our staff also assists with negotiations on the classification of your device. We identify labeling claims best suited to your objectives and write bibliographic reviews that may in the end allow approval to market the device without the need for clinical data. In short, we help clients optimize the design of the clinical research program. We also ensure that there is adequate statistical input to the design to justify the number of patients and ensure the data generated are going to be adequately powered to meet the client’s needs. In some cases, the commercial objectives for a clinical research program are not immediately obvious. CSI works with the client to perform a market assessment allowing the target market to be identified, quantified and qualified. We undertake desk research and then interview key opinion leaders as part of the market assessment. We also organize focus groups and advisory boards, providing short and long term technical, clinical and commercial support for senior management.

Study Protocol/Clinical Investigational

We work from a basic concept to produce a document acceptable to investigators, regulators and IRBs that is compliant with all applicable regulations and therefore suitable for clinical trial submissions. The document can be produced in as little as a week depending on your initial study design. CSI is experienced in liaising with client marketing teams to ensure that commercial objectives are addressed in the study.

Study Site Identification

CSI has access to many of the worlds leading medical facilities. No matter if your investigation is to be carried out in the US, UK, EU, Australia or any other global location, CSI can identify and arrange contractual agreements with the appropriate health care facilities and medical centers. Your specific requirements are considered to ensure that sound scientific data is obtained from reputable investigators and globally recognized medical facilities.

Principle Investigators

Appropriate opinion leader or clinical researcher selection is critical to the success of any clinical study. CSI undertakes a detailed search for qualified individuals (US and Europe) using its own internal database, knowledge and published information. An initial specification is developed with the client and the clinician/surgeon investigators found are rated against that specification. It is important that the specification takes into account all aspects required by the clinician/surgeon investigators (key opinion leaders, senior management advisors, marketing mentors or clinical research investigators). CSI interviews potential collaborators by telephone and/or face-to-face before any agreements are put in place.

Report Writing

CSI prepares clinical research reports to meet all regulatory and commercial needs. These reports include Final Reports, Clinical Data Reviews, Literature Search Reports, technical and scientific reports and manuscript development. The CSI Technical Writer and Graphic Artist can assist you with the design and development of your Instructions for Use, User Guides, Manuals and Patent Applications.

Medical Device Brokerage