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Evidion Clinical Research Partners
Evidion Clinical Research Partners
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We remove the struggle out of cost vs data credibility

Therapeutic Areas

Startup Friendly, Flexible & Scalable Services

Startup Friendly, Flexible & Scalable Services

We provide clinical and regulatory support across a wide range of medical specialties, including: 

  • Structural Heart & Vascular 
  • Neurovascular 
  • Orthopedics & Sports Medicine  
  • Robotic Surgical Systems 
  • ENT, Urology & Neuromodulation 
  • Orthobiologics 

Startup Friendly, Flexible & Scalable Services

Startup Friendly, Flexible & Scalable Services

Startup Friendly, Flexible & Scalable Services

We envision a future where healthcare is more accessible and effective. We partner with startups and small to mid-size companies offering cost-effective end-to-end pre-clinical, clinical & regulatory expertise. We also offer fractional and tiered consulting packages.

Faster Time-to-Market

Startup Friendly, Flexible & Scalable Services

Faster Time-to-Market

MedTech companies must move fast. 

We help streamline regulatory and market access strategies—leveraging adaptive trials, meaningful clinical and health economic endpoints, and real-world PMCF data as smart alternatives to large, expensive trials 

Our Services

Global Clinical Strategy

Market Access & Reimbursement

Global Regulatory Strategy

  • Evidence Generation Plans
  • Design Pre-clinical, First-in-Human/ Early Feasibility, Pivotal IDE, and Post-market Trials
  • Prioritize Clinical Endpoints & KPIs 
  • Statistical Analysis Plan
  • Cost-Effective & Efficient Protocols
  • Investigator brochure
  • eCRF development
  • Enrollment & Retention strategies
  • Real-world evidence collection

Global Regulatory Strategy

Market Access & Reimbursement

Global Regulatory Strategy

  • Navigate FDA, EU-MDR, UK MHRA, Health Canada, and APAC regulatory pathways
  • FDA IDE, PMA, 510k, and De Novo submissions
  • Pre-submission support to de-risk clinical trials
  • CEPs, CERs, PMCF Plans, PSUR, SSCP
  • Benefit-Risk assessment
  • Annual study reports

Market Access & Reimbursement

Market Access & Reimbursement

Market Adoption & Evidence Dissemination

  • Build value-based evidence to differentiate your device/therapies for investors, buyers, and payers
  • Align clinical strategy with payer expectations
  • Support health economics and outcomes research (HEOR)

Market Adoption & Evidence Dissemination

Market Adoption & Evidence Dissemination

Market Adoption & Evidence Dissemination

  • KOL Engagement
  • Identify opportunities for new clinical evidence 
  • Set up Clinical Advisory Boards
  • Define Podium/Publication Strategy
  • Create podium presentations, white papers, manuscripts and abstracts

Medical Affairs

Market Adoption & Evidence Dissemination

Fractional Services

  • KOL Development
  • Investigator-Initiated Research 
  • Medical Safety
  • Clinical Advisory Boards planning
  • Develop medical education curriculum for surgeons 

Fractional Services

Market Adoption & Evidence Dissemination

Fractional Services

  • Clinical Operations Oversight
  • CRO selection and oversight
  • DSMB/CEC/Corelab selection
  • Identify KOLs for clinical areas 
  • Manage Investigator Meetings
  • Monitoring of trial metrics
  • Build in-house clinical teams
  • Interface with regulatory bodies for clinical study discussions 

  • Contact Us

Evidion Clinical Research Partners LLC

vbhal@evidionx.com

+1 901.201.9114

Copyright © 2025 Evidion Clinical Research Partners - All Rights Reserved.

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