Strategy and Compliance Consulting

MMC has been instrumental in designing and executing early stage clinical trials and working with key investigators in Europe, United States, South America, Australia and New Zealand and Asia. Essential for emerging growth companies in the US, timeliness in strategizing early stage development, study design, approvals and study completion is our focus.

 

MMC recognizes the importance of working with the “right” scientific advisor to assist clients in maximizing the potential of their investigational product. Over time MMC has developed relationships with investigators who have not only conducted and contributed to these studies but, more importantly, have changed the known landscape in the world of interventional cardiology and the transcatheter treatment of structural heart disease.

Broad range of services to include:

  • FDA Early Feasibility

  • FIM (OUS and US)

  • IDEs

  •  PMAs

  • Current latest regulatory requirements

  • Assistance with scientific publication

  • Technical Writing and Study Development 

Clinical Development Consulting

MMC Medical has extensive experience designing numerous clinical development plans and working with study sponsors to conduct research at sites best able to support the specific medical device from entry into clinical development through product launch and into late phase launch.   The key to a successful clinical development plan is to remain focused on the most important clinical objectives and defining key study safety and performance endpoints that will further justify efficacy of the device or novel approach. “This is what we do best”.

Clinical Consulting Services include:

  • Protocol development assistance: consultation on study designs, endpoints, objectives, measurements and statistical analyses

  • Scientific and medical oversight of on-going trials

  • Feasibility assessments

  • Advisory consultant for sponsor with the team of Principal Investigator, co-investigators and site coordinators

  • Milestone and Endpoint monitoring

  • Prepare literature reviews

  • Prepare Investigator Brochures

  • Clinical SOPs and Operations

  •  Investigator meeting

  • IRB/EC submission

       o   Informed Consent

       o   Clinical Trial Agreement

       o   Case Report Form design

       o   eCRF training 

  • Site selection, qualification and support

  • Patient recruitment and retention strategies

  • Electronic Data Capture design and training 

  • Interim Monitoring and Study Close-Out

      o   Clinical documentation and study reports

      o   Routine communications with the sites throughout the study

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