Insight Medical

The Insight to Drive Innovation

At Insight Medical, we drive innovation in the most efficient and effective ways possible. We are your partners for the total development and clinical execution cycle, from concept to commercialization. We are distinguished by multi-faceted experience in drug, device, cell therapy and combination products.  We excel in thinking creatively, applying a holistic approach to your innovative medical device or drug product.

Insight’s service offerings include strategic clinical and regulatory consulting, preclinical program design, comprehensive clinical operations, and regulatory guidance.


Strategic Partnering

Successful product launch begins with a strategy that ties key marketing claims to the right regulatory and commercialization pathway.

· Regulatory/clinical consulting

· Clinical study design

· Interpretation of clinical data

· Development of concise and effective key messaging for regulatory authorities


Preclinical

Bench and animal studies are paramount in effectively establishing the initial safety profile of a product to support a clinical trial application.

· Pre-clinical and animal study design

· Guidance on addressing regulatory feedback on biocompatibility, toxicity, etc.


Clinical Operations

An optimized clinical operations team is critical to ensure the effectiveness, safety, compliance and integrity of your clinical trial.

· Program and project management

· Site management, from site selection, qualification, and initiation through close-out

· Full clinical monitoring services

· Trial Master File (TMF) development and maintenance

· Safety management, encompassing review of AEs, medical coding, safety reporting and safety committee oversight

· Data management, including database development through cleaning and analysis

· Statistical analysis plan development and biostatistical services

· Study rescue


Regulatory

Our experts can help navigate the complex regulatory landscape to minimize your risk and increase the likelihood of success with global regulatory authorities.

· Regulatory submission strategy

· Medical writing and preparation of regulatory submissions

· Regulatory correspondent and team lead in interactions with regulatory authorities