Clinicians, payers, regulators, and patients are demanding clinical evidence to demonstrate safety, effectiveness, and overall value of innovation. Designing and conducting your medical device study requires expertise, from thoughtful study design to efficient execution, in order to demonstrate clinical value.

With a comprehensive clinical development solution encompassing clinical strategy, protocol development/study design, site selection, end-to-end clinical operations, and best-in-class supportive services, we ensure your clinical trials are efficient and successful.

For Clinical Development Services Optimized For MedTech, Veranex Is Your Difference

Services:

  • First-in-human
  • Early feasibility/feasibility
  • Pivotal
  • Postapproval study (PAS)
  • Postmarket surveillance
  • Patient registries
  • Case report forms (CRFs)
  • Informed consent
  • Investigator brochure
  • Clinical management and safety plans
  • Clinical strategy evidence planning
  • Comprehensive literature searchesRisk and complexity assessment
  • Trial design consulting
  • Biostatistical strategy and analysis plan
  • Protocol writing
  • Peer review
  • Identification/selection/activation/initiation
  • Institutional review board (IRB)/ethics committee (EC) submission
  • Interim monitoring/oversight
  • Investigator agreements qualification
  • Regulatory files
  • Study budgets
  • Training
  • Closeout
  • Patient identification
  • Study marketing and patient advertising

  • ClinicalTrials.gov reporting and updates
  • Establishment and management of data and safety monitoring boards (DSMBs) and clinical event committees (CECs)
  • Maintenance of essential documents/central study files
  • Investigator meetings
  • Development of manual of operations
  • Data monitoring plan and oversight
  • Data management and query resolution
  • Reading center/core lab interface
  • Review and classify adverse events (AEs)
  • Generate AE narratives and reporting
  • Bioresearch monitoring (BIMO) inspection preparation and support
  • Site monitoring plans and oversight
  • Data integrity audits
  • Data query resolution
  • Independent reading centers interface
  • Core lab interface
  • Review and compile AE material
  • IDE annual progress reports
  • Statistical analysis reports (SARs)
  • Interim and financial clinical study reports

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