Preclinical

Our Preclinical Expertise

  • We support the entire development process, from early-stage R&D through non-GLP proof-of-concept and feasibility studies, into GLP regulatory studies, and ultimately facilitating clinical advancements.
  • We utilize both small and large animal models, ensuring that every study is designed in collaboration with the sponsor to tailor models to specific product applications, seamlessly linking in vitro assay development to surgical study endpoints.
  • Our expert regulatory guidance and consulting services provide comprehensive support at every stage of development.

Our Facility

  • Our 30,000+ sq. ft. facility consists of procedure suites with attached conference rooms, livestream video capabilities, animal rooms, and dedicated storage closets for clients.
  • Our Catheterization (cath) lab features a Siemens Artis Zee fixed, flat detector C-arm while our two alternate operating room suites have mobile C-arm capabilities.
  • Element Research Group has a fully equipped necropsy suite and full-time prosector. In addition to full-service necropsy capabilities, we coordinate histological tissue processing. Capabilities include plastic and paraffin embedding and sectioning, as well as common and specialized stains. Pathology services are also coordinated with Board-Certified Veterinary Pathologists.
  • Our laboratory support offerings include in vivo blood loop testing, general laboratory space, clinical pathology, -80 degree storage, liquid nitrogen, and more.

Our Equipment

  • Fluoroscopy (Siemens Artis Zee Digital Cath Lab)
  • Siemens Mobile C-arm
  • 3D Rotational Fluoroscopy with Siemens DynaCT
  • Intracardiac (ICE) and Duplex Ultrasound (Siemens Acuson SC2000, GE Vivid S70N)
  • AD Instruments PowerLab Digital Acquisition System
  • DSI-PhysioTel Digital Equipment
  • Mindray Veta5 Anesthesia Machines and Animal Monitoring Equipment
  • Steam and ethylene oxide sterilization capabilities
  • Cardiopulmonary Bypass Pump System
  • Cardiopulmonary Bypass & Extracorporeal Membrane Oxygenation (ECMO)
  • Intravascular Ultrasound (IVUS) Systems
  • Endoscopic and Laparoscopic Tower

Model Development

Our team’s extensive experience with model development can help identify possible risks and design flaws in your product early on, saving you time and money in the long run. Our areas of expertise include:

  • Thrombectomy
  • Aneurysm
  • Hypertension
  • Heart failure

Training Programs

Provide physicians, engineers, technical staff, and the sales force with critical didactic and hands-on training prior to human use.

Cadaveric Studies

Test the biomechanics of your product utilizing our cadaveric specimens to obtain critical information about device behavior without any risk to patients.

Pre-Clinical Leadership Team

Meet the experienced professionals dedicated to advancing medical research.

Stephanie Fettig-Scholl

Stephanie Fettig-Scholl

Founder and CEO

Cassandra Jarmoluk-Miske (Director of Preclinical)

Cassandra Jarmoluk-Miske

Director of Preclinical

Joanna Nowakowska (Director of Surgical and Animal Services)

Joanna Nowakowska

Director of Surgical and Animal Services

Miranda Dvorak

Miranda Dvorak

Quality Associate

GLP & Non-GLP Expertise

  • Wound Healing & Repair
  • Dental
  • Neurovascular/Neuromodulation
  • Pulmonary
  • Gastroenterology
  • General Surgery
  • Ophthalmology
  • Nephrology
  • Diabetes Care
  • Solid Organ Transplant
  • Orthopedics
  • Pharmacokinetic (PK) Studies
  • Tendon Repair
  • Cardiovascular
  • Cardiopulmonary Bypass
  • Coronary Artery Bypass Grafting (CABG)
  • Coronary Angiography & Stenting
  • Electrophysiology (EPS)
  • Extracorporeal Membrane Oxygenation (ECMO)
  • Ablations
  • Valve Repair & Replacement (TAVR, TMVR)
  • Heart Catheterization & Arteriotomy Closure
  • Pacemaker & ICD Testing
  • Hemostasis
  • Peripheral Vascular/Artery Disease
  • Cardiac Catheters & Guidewires