Dedicated Expertise.

Unlike the largest CROs, Novella has a dedicated team that serves only medical device and diagnostic companies. Led by a management team with over 25 years operational leadership, each project team member is a fully dedicated device expert, and most have deep histories with sponsor companies. Novella's professionals understand the intricacies and nuances of device trials, and unlike many niche CROs, Novella has the global footprint, regulatory acumen and quality management systems to serve your trial well.

Novella's corporate experience spans the following:

  • Feasibility/Proof of Concept
  • Pivotal
  • Post Market Support/Registry
  • Class II/510(k) and PMA
  • Class III IDE/PMA
  • Combination Products
  • Biologics
  • Diagnostics

Novella serves the following therapeutic areas:

  • Cardio/Vascular
    • CHF (congestive heart failure), CAD (coronary artery disease), Angina, HTN (hypertension), Dysrhythmia, Aortic Aneurysms, PVD (peripheral vascular disease)
  • Oncology
    • Prostate
    • Liver
  • General Surgery
    • Wound Healing
    • Urology
    • Women's Health
    • Nephrology
    • Endocrinology
  • Orthopedic/Spine
    • DDD (degenerative disc disease), AVN (avascular necrosis), three piece ankle

Medical Device & Diagnostic Experience:

  • Pacemakers
  • Internal cardiac defibrillators (ICD)
  • Cardiac lead replacements
  • Resynchronization therapy (CRT-P/CRT-D)
  • Drug eluting stents (DES)
  • Bare metal stents (BMS)
  • Carotid stents
  • Extra cellular scaffolds
  • Cardiac ablation catheters
  • Vascular stent grafts
  • Ventricular assist devices (VADs)
  • Spinal fixation
  • Orthopedic hip
  • Stem cells
  • Neuromodulation devices
  • Endovascular devices
  • Drug delivery systems
  • General surgery devices
  • Diagnostic glucometers
  • Diagnostic single assay panels

Interesting in learning more about how Novella's Medical Device and Diagnostics division works? 


Bullet Graphic  Download our fact sheet here.

 

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