At Novella, there are no “more important” clients.

Dedicated, individualized client service.  Experienced project teams.  Global capabilities. Just three reasons Novella’s Medical Device & Diagnostics division is the fastest growing segment of our business. 

We’ve supported trials from 10 to 7,000 patients and from two to more than 1,100 investigational sites. Yet every client is our most important client. 

Core Services

  • Program Management
  • eCRF Design & Programming
  • EDC Application Hosting (Oracle’s InForm™)
  • Study Start-Up & Investigator Recruitment
  • eClinical Investigator & Staff Training
  • Clinical Monitoring
  • Data Management
  • Biostatistics
  • Medical Writing
  • Medical Monitoring
  • Product Safety and Pharmacovigilance

In addition to our core services, Novella offers expansive consulting services.

Consulting Services

  • IDE Regulatory Assessments (U.S. and Europe)
  • Class II 510(k) meeting request and submission dossiers
  • Pre-IDE Meeting Participation
  • Report of Prior Investigations
  • Protocol Development
  • Class III PMA Support (Medical/Clinical)
  • Clinical Development Support
  • Comprehensive IDE Regulatory Support and Submissions
  • Reimbursement Strategies
  • Centers for Medicare & Medicaid Services (CMS) Guidance and Quantitative Analysis
  • Clinical Development Cost Analysis
  • Agency Audit Support and Warning Letter Resolution
  • SOP Development
  • Health Economic Licensing and Analysis
  • Safety Reporting
  • FDA BIMO Field Inspection Preparation
  • Device Classification/Predicate Device Searches
  • Import/Export Requirements and Management
  • Creation of Technical Design Files
  • Post-Market Support

Outsourcing Services

Supplementing our in-house expertise, through Novella Clinical Resourcing we also have access to more than 700 clinical professionals, including CRAs, with extensive medical device clinical and trial experience. 

  • Expert staffing is provided based on medical device therapeutic experience, clinical background, geographic proximity, and length of assignment
  • Flexible staffing models including:
    • Single position
    • Team resource building
    • Functional outsourcing
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QuoteI feel like I am working with a team rather than consulting with a vendor and am very impressed with the quality of individuals that Novella Clinical employs. I am most pleased with the Project Management coordination and the CRA Resourcing, which has provided exceptional regional CRAs for our project.Quote

Global Project Manager,
Cardiovascular Medical
 Device Company

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