Services
Efficient Clinical Trial Strategy, Planning, Design and Execution across the full-spectrum of the regulatory paths: IDE, IND, Prospective Randomized, Post Market, Retrospective Cohort or Case Series
Biostatistics and Data management with part 11 compliant electronic data capture
Monitoring
Protocol and CRF Development
Investigator Meetings and Advisory boards
Site Selection and Enrollment
Pre-Clinical and Bench Design and Execution
Experimental Design
Cadaver and/or Animal Experiments
Regulatory Support and Clinical Development Plans
510(k), PMA
IDE, IND
Additional indications or claims language with either new or existing data
Publication Strategy and Medical Writing
How to launch your product with evidence
Peer Reviewed Manuscripts
Abstracts and Presentations
Technical aspects of regulatory submissions
Marketing Materials
Executed Clinical Trials: Drugs, Devices, Combinations, & Diagnostics/IVD
A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection with Alternating Irrigation of Vancomycin HCl and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty: A combination drug and device clinical trial
Magneto-encephalographic Response to Median Nerve Stimulation Correlates with Recovery of Sensory and Motor Function after Stroke
Bi-polar Vessel Sealing in Atherosclerotic Vasculature
The impact of atherosclerosis and vascular collagen on energy-based vessel sealing.
Effect of collagen and elastin content on the burst pressure of human blood vessel seals formed with a bipolar tissue sealing system
Quantifying Inadvertent Thermal Bowel Injury from the Monopolar Instrument
An evaluation of the impact of collagen to elastin ratio on burst pressure of arterial seals created using a bipolar vessel sealing device in a porcine model
Magneto-encephalographic brain mapping as a replacement for the WADA test in pediatric epilepsy patients
Clinical Outcomes After Lobectomy with Bi-polar radiofrequency Energy Sealing of the Lung as an Alternative to Staples
Effect of catechol-O-methyltransferase val(158)met polymorphism on the p50 gating response as measured with Magnetoencephalography
A Phase 2 Multicenter Trial to evaluate the safety and efficacy of Abilify (aripiprazole) in the reduction of psychotic symptoms in patients diagnosed with schizophrenia
A Phase I Feasibility Study of Safety and Efficacy of Sealing of the Cystic Duct with Bi-polar Energy During Cholecystectomy vs. clips
A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Percutaneous Radiofrequency Ablation for Osteoid Osteoma
A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Percutaneous Radiofrequency ablation for Stage I-IIA renal cell carcinoma
A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Percutaneous Radiofrequency ablation for Stage I non-small cell lung carcinoma in inoperable patients
A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Percutaneous Radiofrequency ablation for hepatocellular carcinoma
A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Percutaneous Radiofrequency ablation for colorectal cancer liver metastases
Clinical Outcomes After Lateral Lumbar Interbody Fusion (LLIF) Supplemented with Spinous Process Fixation for Lumbar Degenerative Disc Disease and Spondylolisthesis
Single Center Evaluation of Patients with Degenerative Disc Disease and/or Spondylolysthesis Undergoing Fusion with the Aspen MIS Fixation System
An Investigation of the Promotion of Fusion Following Spine Fixation Utilizing ASPEN with or without Pedicle Screws
Clinical and Radiographic Outcomes in a Retrospective Cohort of Lumbar Fusion Patients with the Aspen Spinous Process Fixation System
A Single-Center Retrospective Review of the ASPEN™ Spinous Process System Compared to Alternate Fixation in Lumbar Fusion
SpF® Implantable Spine Fusion Stimulator Retrospective Medical Record Review
Cellentra™ Viable Cell Bone Matrix (VCBM) Posterolateral Lumbar Fusion Outcomes Study
A Prospective Multi-Center Trial to Assess the Safety and Efficacy of the Impliant Tops System
Dynesys Spinal System Post Market 522 Study
A Single Center Study of Perioperative Economic and Clinical Differences Between Open and Minimally Invasive Approach for Anterior Lumbar Interbody Fusion- NuVasive
Study to Determine Incidence of Large Annular Defects & Volume of Disc Removed in Primary Discectomy Patients
A Prospective Multicenter Study to Investigate Re-herniation Risk Factors and Associated Costs in Primary Lumber Disc Herniation
A Prospective, Efficacy Study of Titan Spine Endoskeleton TT Transforaminal Interbody Fusion Device in Patients Undergoing Single or Multiple Level Interbody Fusion for Disease of the Lumbar Spine
A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection with Alternating Irrigation of Vancomycin HCl and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty
Retrospective Analysis for Safety and Efficacy of 4WEB Cervical Truss System in Multiple Level Cervical Spine Fusion
Prospective Single Center study of 4WEB® Medical Lateral Spine Truss System Compared to Retrospective Analysis of PEEK Implants: Clinical and Radiographic Outcomes
A Prospective Clinical Trial Evaluating Safety and Effectiveness of Lumber Discectomy with the addition of an Annular Closure Device in Patients with Large Post-Surgical Annular Defects for the Prevention of Re-herniation
A Prospective Randomized Multicenter Study To Demonstrate the Superiority of Barricaid to Discectomy for Primary Disc Herniation- OUS
Retrospective Review with Prospective Surveillance of Safety and Efficacy in a clinical series of Spinal Tethering patients
A Multi-Center Prospective Randomized Study to Evaluate the Efficacy of the ASPEN™ Spinous Process System for use in Anterior Lumbar Interbody Fusion (ALIF)
A Multi-Center Prospective Randomized Study Comparing Supplemental Posterior Instrumentation, Aspen™ Spinous Process System versus Pedicle Screw Fixation, in Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
A Multi‐Center Prospective Study Evaluating Aspen™ Spinous Process Fixation System for use in Posterolateral Fusion (PLF) in Patients with Spondylolisthesis
DHEA augmentation of musculoskeletal adaptations to exercise in older women
Improving Symptoms and Quality of Life in Advanced Chronic Heart Failure
A Stepped Care Intervention to Reduce Disparities in Mental Health Services among Underserved Lung and Head-and-Neck Cancer Patients and their Caregivers
An Assessment of the Impact of Motivational Interviewing via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence
Health Information Technology to Support Clinical Decision Making in Obesity Care (pragmatic trial) Online Social Networking for HIV Prevention
Alcohol, Marijuana, and Risky Sex: Group Interventions with Detained Adolescents
HIV prevention with adolescents: Neurocognitive deficits and treatment response
Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment
Effect of holding on co-regulation in preterm infants: A randomized controlled trial
Muscle Treatment for Management of Pain & Disability in Tension-type Headache
DSMB Involvement/Other Service
NIH/NHLBI 1R01HL136403 A Multicenter Trial of a Shared Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators (PI: D. Matlock)
Member, Independent Monitoring Committee, NIH/NCCIH R0AT00954 An observational study of effects of edible cannabis and its constituent cannabinoids on pain, inflammation, and cognition (PI: L.C. Bidwell)
Roche CT/NG (Molecular Dx)
Roche TV/MG (Molecular Dx)
Ventana MMR IHC Panel
Ventana ALK CDx
Bulhmann Labs (Calprotectin)
Multiple Clearances (10+) for additional Indications in PD-L1 diagnostics
Agilent-Dako and Ventana
Roche HPV ATHENA Trial
Biomerieux - BACT/ALERT® BPA and BPN have received 510(k) clearance from the FDA for quality control testing of LRAP units with BACT/ALERT® VIRTUO®