Clinical Development Capabilities

Project Management provides the operational structure that keeps a study aligned and moving. At Avania, PM is a strategic leadership function: coordinating teams and vendors, managing risk, and maintaining consistent communication across all stakeholders.

Our PM teams:

• Maintain cross-functional alignment, timelines, and issue escalation
• Lead risk oversight and decision pathways
• Coordinate operational components of Data Monitoring Committees and Clinical Events Committees, including scheduling, documentation, and charter implementation
• Ensure information flow remains secure, independent, and compliant

This approach keeps complex device studies organized, responsive, and inspection-ready.

Clinical Operations is the operational core of every device trial. Our model is built around deep site partnership and detailed understanding of procedural and diagnostic realities.

Key elements include:

• High-touch site engagement that supports protocol fidelity and accountability
• Alignment on procedural technique and workflow accuracy
• Monitoring approaches that distinguish device performance from operator, workflow, or patient variability
• Rapid communication loops for real-time clarification and correction
• Close collaboration with Field Clinical Specialists during early and complex cases
• Full readiness planning to ensure sites are prepared for device use
• Comprehensive data review to support accurate endpoint collection

This ensures evidence reflects both performance and the operational context in which a device is used.

Field Clinical Specialists provide real-time procedural insight and hands-on reinforcement of technique, a critical differentiator in MedTech clinical development.

FCS teams:

• Support investigators during early and key cases
• Train procedural teams with methods aligned to real-world workflows
• Conduct pre-case planning and post-case debriefs
• Identify technique, usability, and workflow challenges as they occur
• Partner closely with Clinical Operations for closed-loop issue resolution

Their presence elevates device technique consistency, safety evaluation, and performance data quality.

Data Management captures and validates the operational realities of device use.

Our teams:

• Design CRFs that reflect actual procedural and diagnostic workflows
• Oversee clinical, imaging, timing, and assessment data
• Apply validation checks that detect workflow deviations and timing inconsistencies
• Work with Clinical Operations and FCS to contextualize anomalies
• Produce clean, inspection-ready datasets representing true device behavior

This ensures analytic clarity grounded in what occurred at the point of care.

Avania’s biostatistics group designs and interprets data with an understanding of device performance, operator technique, and measurement-based endpoints.

Capabilities include:

• Device-appropriate study design, including operator effects and learning curves
• Safety and performance analyses
• Diagnostic accuracy evaluation, including sensitivity, specificity, predictive values, and ROC methods
• Modeling of procedural or site-level variability
• Oversight of missing data, follow-up patterns, and adherence
• Statistical support for DMC activities, interim analyses, and closed/open session reporting

The result is statistical output that stands up to regulatory and scientific scrutiny.

Our Clinical Regulatory and Medical Writing team produces documentation that accurately reflects study conduct and supports global submissions. This group works alongside Clinical Development and remains distinct from Avania’s advisory regulatory consultants.

We prepare:

• Protocols tailored to procedural and diagnostic workflows
• Investigator Brochures, risk materials, and IFUs
• Clinical Study Reports grounded in verified operational insight
• CERs and PMCF/PMPF documentation
• IVD performance evidence packages
• Submission-ready clinical documentation for regulators worldwide

Every deliverable aligns clinical reality with regulatory expectations.

Safety Management incorporates procedural and operational context into every assessment. Device studies generate safety signals from technique, usability, workflow, or device behavior; our model accounts for all pathways.

We manage:

• Procedural complications and technique deviations
• Device performance concerns and malfunctions
• Diagnostic or measurement anomalies
• Human factors and usability issues
• Workflow-related safety patterns
• Study-level and cross-site trend detection

Our team supports CEC and DMC activities, preparing adjudication packages, narratives, and evidence summaries. Recommendations are incorporated quickly and accurately into ongoing safety oversight.

Avania provides full clinical, operational, and statistical support for CECs and DMCs.

Support includes:

• Charter development
• Member identification and qualification
• Operational management, logistics, and secure information exchange
• Preparation of adjudication files and narratives
• Blinded and unblinded review support
• Interim and trend analyses
• Documentation and follow-up of committee actions
• Integration of outcomes into Safety, Data Management, and study operations

This gives independent reviewers clear, structured information to guide decisions.

Quality Assurance provides oversight across the study lifecycle to maintain alignment with ISO 14155:2020, MDR/IVDR, FDA requirements, and sponsor-specific standards.

Activities include:

• Document and process review
• Risk assessments that support operational quality
• Audit planning, execution, and follow-up
• Monitoring oversight and vendor qualification

QA ensures consistency, compliance, and readiness for inspection.

RBQM is embedded across Clinical Development to identify and mitigate operational, data, and safety risks early.

Our model includes:

• Early cross-functional risk identification
• Centralized and trigger-based monitoring
• Detection of operational or procedural drift
• Integrated reviews with Operations, FCS, Data, Safety, Biostats, and PM
• Clear mitigation pathways and documentation
• Continuous trending to maintain study integrity

This supports high-quality, reliable safety and performance evidence.

Imaging Core Lab services provide standardized, independent evaluation of imaging endpoints, reducing site-to-site variability and strengthening the reliability of clinical evidence. Our platform is built to regulatory standards and designed for efficient, secure data flow across all trial stakeholders.

Our capabilities include:

• Image transfer encryption and pseudonymization compliant with CFR 21 Part 11 and ISO 27001:2017
• Centralized review by radiologists and nuclear medicine specialists
• Consistent evaluation of imaging-based endpoints to minimize variability
• Integrated query management for streamlined communication
• User-friendly access for hospital staff, CRO teams, and sponsors
• Rapid support from a dedicated imaging operations team

This centralized model ensures objectivity, consistency, and high-quality imaging data. Reviews are delivered with the rigor needed for regulatory submission and the clarity required for clinical decision-making.