A successful clinical development strategy considers not only regulatory needs, but also marketplace expectations around product uniqueness and value. At Medical Imaging Consultancy we help develop and/or refine your clinical & scientific strategy and roadmap for Phase I through regulatory submission. We strive for cross-functional collaborations across medical, scientific, commercial and payor input into your developmental program. Alignment with your strategy with your corporate goals is important to us, aiming for highest impact possible with the minimum expenditure of time and resources.
Your regulatory pathway towards FDA approval is unique to your situation. You understand the technical considerations and risks specific to your product and offering. In collaboration with you, we translate your specific situation to determine the best safety and efficacy evidence needs for FDA approval of your product. We also assess if you may be able to take advantage of any special designations, such as Fast Track and Breakthrough designations.
Via interactions with investigators, thought leaders and your team, we translate scientific/clinical content into actionable information for your company. We help develop and draft scientific materials including scientific papers, summary clinical data for positioning of product with investors or collaborators. If needed, we represent you and present your clinical data to external audiences, including industry partners, investors, regulators and scientific conferences. As the product approaches approval and market launch, we work with you and your commercial team to position and launch your product for the best impact and market penetration.
Among our core strengths are the ability to effectively Integrate the unique aspects of medical imaging into clinical trial design. In collaboration with your clinical team, we will create study designs that will most effectively generate evidence to answer critical regulatory questions, while maintaining alignment with your clinical strategy. Correct quantitative image analysis can make or break an excellent product. We help find the best image analysis methods and standardize reading for eventual clinical translation. In addition, we have expertise in kinetic tracer modeling, clinical biodistribution studies and radiation dosimetry to support your clinical development.
In collaboration with your team, we provide a suite of operations support. We help drafting and review of clinical protocols and all other study related documents. We support interpretation and communication of clinical trial data. With our prior experience with clinical imaging sites across the US, we provide clinical and medical input in site and vendor selection and management. We undertake site visits for initiation, activation, enrollment enhancing activities and engagement, among many other things. We manage your imaging operations or monitor your CRO/IRO's activities.
A very critical piece of moving a product towards FDA approval involves careful Chemistry, Manufacturing and Control strategy and development. We help with your CMC strategy, planning - optimization, validation etc., technical support in manufacturing, QC, QA, regulatory needs, Drug Master File filing, FDA interactions during IND filings, Annual Reports/audits etc. In addition, our consultants can help with lab design and setup, equipment qualification, and process implementation. We can also help with tech transfer, when required.
Are you evaluating a new imaging technology or company to either invest in or partner with? We guide your decisions by assessing the scientific basis and strength of the technology and the competitive landscape. Your business decisions may depend on identifying the next inflection point or key developmental milestones. We support your analysis by evaluating the pipeline products, stage in development and likelihood of full regulatory approval as well as the potential for clinical impact and acceptance.
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