purple background
What We Do Clinical Development Study Types

Study Types

Your MedTech Champion for High-Quality Evidence Across Every Study Type

Avania supports the full spectrum of MedTech study designs, each requiring operational models that reflect how devices are used in real clinical environments. From early feasibility through post-market surveillance, our teams align technique, workflow, and investigator engagement to produce evidence that is accurate, contextual, and regulator-ready.

Medical Team Meeting

Need Flexible Support for Your Study?

See how Avania’s FSP model extends your internal team with dedicated expertise in operations, monitoring, data, safety, and more.

Clinical Study Models We Support

FIH studies demand tightly coordinated execution, where small variations in technique, workflow, or site readiness can influence early safety and performance outcomes. Avania builds operational control into every step to protect early data quality and device understanding.

Our operational model includes:

  • Targeted site identification and qualification
  • Detailed workflow mapping before first use
  • High-touch onboarding of procedural teams
  • Field Clinical Specialist support during early and high-risk cases
  • Rapid communication across Operations, Safety, and Project Management
  • Usability and user-interaction documentation
  • Heightened safety monitoring
  • Early-phase data validation designed to capture operational variability

Outcome: Early evidence that is safe, contextual, and credible.

Diagnostic studies require precision across sample handling, timing, workflow, and comparator methods to ensure analytical accuracy reflects real-world conditions. Our approach is grounded in operational detail across pre-analytic, analytic, and post-analytic phases.

Our operational model includes:

  • Workflow-informed site and lab selection
  • Training for sample collection, timing, processing, and result handling
  • Oversight of sample management from receipt through reporting
  • Comparator method coordination and reference testing oversight
  • Real-time quality checks to detect timing or handling deviations
  • Data capture aligned to diagnostic workflow
  • MDR/IVDR clinical performance documentation

Outcome: Diagnostic evidence that is reproducible, accurate, and operationally sound.

Pivotal trials require consistent execution across all sites. Avania reinforces disciplined operational control and investigator alignment to ensure reproducible, regulator-ready evidence.

Our operational model includes:

  • Comprehensive site initiation and training
  • Ongoing alignment of procedural technique
  • Monitoring designed to detect operational drift early
  • Structured communication across investigators and sites
  • Integration of central review processes, including imaging and adjudication
  • Device-specific data quality programs
  • Rigorous follow-up management
  • Safety oversight grounded in procedural context

Outcome: Reproducible evidence suitable for regulatory submission.

Post-market programs must capture long-term performance and safety under real-world conditions, where variability is higher and workflows differ across sites. Avania structures PMS delivery to manage ongoing complexity and support global regulatory expectations.

Our operational model includes:

  • Sustained long-term follow-up strategies
  • Workflow-aligned real-world data capture
  • Oversight of device use patterns and technique variability
  • Trend analysis across diverse clinical environments
  • PMCF/PMPF support under MDR/IVDR
  • Integrated signal detection processes
  • Reporting structures for regulatory and commercial needs

Outcome: Meaningful real-world evidence that supports safety, performance, and lifecycle value.

Medical workers analyzing medical images

Strategic Guidance Embedded Across Every Study Type

Avania’s clinical development teams work in direct partnership with our strategic advisory experts, ensuring each study is shaped by deeper regulatory, engineering, and market insight. This integration strengthens protocol design, anticipates workflow and submission risks, and aligns evidence generation with long-term commercial and regulatory needs.

The result is a study approach that is operationally sound, context-aware, and positioned to support your device throughout its lifecycle.

doctors talking about new medical practices in a meeting at work

Explore Avania’s Clinical Development Capabilities

Review the full set of integrated functions behind high-quality study execution, from early feasibility through post-market follow-up.


Ready to Plan

Your Next Study?

Connect with Avania’s clinical and operational experts to review your program, assess the right study design, and define a clear path to high-quality evidence and timely execution.

Tell Us About Your Project