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What We Do Clinical Development IVD/Diagnostic Studies

IVD/Diagnostic Studies

Your MedTech Partner for Advancing Diagnostic Evidence with Confidence

IVD development demands precision across analytical performance, clinical validation, regulatory strategy, and market access planning. The margin for error is narrow, timelines are unforgiving, and evidence must withstand scrutiny from regulators, notified bodies, payors, and laboratory stakeholders alike.

Avania accelerates diagnostic development through a MedTech focus and an integrated clinical, regulatory, and market access model. From early feasibility and analytical validation through pivotal clinical studies, we help diagnostic innovators move from milestone to milestone with clarity, rigor, and control, ensuring every study supports approval and long-term adoption.

Key Differentiators:

  • Dedicated IVD team with deep experience across analytical validation, clinical study design, regulatory strategy, and IVD-specific biostatistics
  • Global reach with regional experts fluent in IVD requirements across the U.S., EU, and key international markets
  • Integrated regulatory and market access strategy ensuring studies support approval, coverage, coding, and reimbursement
  • End-to-end MedTech focus that eliminates vendor fragmentation and preserves operational continuity
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Navigating the Complexities of IVD & Diagnostic Studies

Developing an IVD requires navigating analytical performance standards, clinical validation expectations, evolving regulations, and multiple submission pathways, including CLIA waivers, 510(k)s, De Novo classifications, and PMAs. Each pathway carries distinct evidence requirements, and misalignment between study design and regulatory strategy can lead to costly delays or rework.

The stakes are high. Diagnostic companies must demonstrate clinical utility, establish regulatory clarity early, and generate evidence that supports both approval and reimbursement. Avania brings structure to this complexity, ensuring your studies are designed with the end in mind — not just regulatory acceptance, but real-world adoption.

Why Avania: A Specialized Strategic Partner for Diagnostic Studies

Our Experts

The Minds Behind Your Success

Your diagnostic program is supported by leaders with deep experience across IVD regulation, clinical validation, and market access strategy.

Charu Ramkumar

Director, Regulatory

Charu Ramkumar, PhD, MBBS

  • 20+ years of global healthcare experience
  • Expert in oncology and cancer biology and cardiovascular diseases
  • Doctorate degree in general surgery
  • Specialized expert in implantable and minimally invasive surgical devices
Subo Perampalam

Senior Regulatory Consultant

Subo Perampalam, PhD

  • 20+ years of Global Regulatory program leadership for FDA and Health Canada
  • Expert in pulmonary, respiratory, and infectious disease
  • Led multiple Emergency Use Authorizations (EUAs) and Humanitarian Device programs
  • Specialized expertise in IVD diagnostics and EU IVDR CE marking
Eric Lam

SVP Market Access & Reimbursement

Eric Lam, PhD

  • 20+ years of global healthcare experience
  • Doctorate Degree in Pharmacology
  • NIH-sponsored post-doctoral fellowship in Pharmacology and Medicine
  • Specialized expertise in IVD market access
Tom Zimmerman

IVD Principal Consultant

Tom Zimmerman

  • IVD Project Manager qualified and monitored sites/laboratories for every study managed.
  • Authored protocols, monitoring plans/reports and clinical study reports.
  • Managed the clinical study teams for all IVD projects – Data Management, CRAs, Biostatisticians.
  • Project Manager on the first HLA DNA sequencing system and kits approved in the U.S.
  • Project Manager on the original Oncomine CDx study (Ironman) for NSCLC and the approval of the Ion Torrent PGM.

Continuum of Expertise

Avania supports the full IVD journey: from early protocol development and feasibility through analytical and clinical validation, regulatory submissions, and market access strategy. Our teams align study objectives to downstream requirements, reducing risk and preserving momentum across the program lifecycle.

MedTech Focus

Avania is purpose-built for MedTech. Our SOPs, regulatory frameworks, and clinical operations are designed specifically for medical devices and diagnostics, not adapted from pharmaceutical models. This focus translates into studies that reflect how diagnostics are developed, validated, and commercialized in the real world.

Comprehensive IVD & Diagnostic Study Capabilities

Analytical performance studies aligned with CLSI guidelines, including precision, accuracy, linearity, sensitivity, specificity, and robustness testing. Programs are scaled appropriately to device risk and intended use.

Early-stage studies designed to validate assay performance, workflow feasibility, and clinical relevance while informing regulatory and development strategy.

End-to-end clinical performance studies supporting regulatory submissions across IVD classifications. Study designs reflect intended use, target populations, and real-world clinical environments.

Integrated regulatory planning across CLIA waivers, 510(k), De Novo, and PMA pathways. Evidence strategies are aligned with FDA, IVDR, and global expectations from the outset.

Established partnerships with clinical sites, central laboratories, and specialty labs. End-to-end logistics, specimen handling, and sample management tailored to diagnostic studies.

Statistical planning, SAP development, and data management designed for diagnostic performance endpoints, including sensitivity/specificity analyses and agreement studies.

Extensive experience across oncology, endocrinology, infectious disease, cardiovascular, transplant diagnostics, hematology, molecular diagnostics, immunoassays, point-of-care platforms, and companion diagnostics.

Regional regulatory and clinical experts supporting studies across the U.S., EU, UK, Canada, Australia, and global markets, ensuring alignment with local requirements and review expectations.

our approach

Avania’s Integrated Approach to IVD & Diagnostic Studies

Strategic & Collaborative Partnership:

We operate as a true extension of your team, emphasizing transparency, shared accountability, and early problem-solving. Challenges are surfaced quickly, addressed collaboratively, and managed with your long-term objectives in mind.

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Purpose-Built Expertise:

Our diagnostic programs are guided by specialists across regulatory affairs, clinical operations, biostatistics, engineering, and market access. This multidisciplinary depth ensures study designs reflect how diagnostics are built, evaluated, and commercialized.

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Flexible Engagement:

Engage Avania for turnkey diagnostic study execution, targeted gap-filling expertise, or full end-to-end clinical and regulatory support. Our model flexes as your program evolves — start, stop, and scale as needed.

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Operational Excellence & Quality Assurance:

All diagnostic studies operate under robust quality systems aligned with ISO 14155:2020, FDA 21 CFR, MDR, and IVDR requirements. Our SOPs are purpose-built for MedTech and diagnostics, ensuring consistent, inspection-ready execution.

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Ready to Advance Your Diagnostic Program with

Confidence?

Move your IVD or diagnostic study forward with a partner purpose-built for MedTech. Avania integrates clinical execution, regulatory strategy, and market access insight to keep your evidence generation aligned, efficient, and approval-ready.

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