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Diagnostics & IVD Services

IVD & Medical Device CRO Services for FDA-Aligned Clinical Documentation

Specialized CRO Services Built for Diagnostics, IVDs, and Medical Devices

Dynamill Research is a specialized CRO designed for companies developing diagnostic tests, IVDs, medical devices, point-of-care technologies, Software as a Medical Device (SaMD) and regulated digital health products, and AI-enabled device software functions, including clinical evidence to support a Predetermined Change Control Plan (PCCP).

Diagnostics and medical device clinical studies are not the same as traditional drug trials. They require study designs built around the intended use and the indications for use statement, the right patient population and sites, fit-for-purpose endpoints, device accountability or specimen integrity, controlled workflows, and regulatory-ready documentation from the beginning.

At Dynamill Research, we help diagnostics and medical device sponsors move from concept to clinical evidence with a lean, high-touch CRO model built around speed, transparency, and compliance.

Fast. Predictable. Smart.

Why IVD and Medical Device Sponsors Need a Specialized CRO

Diagnostics and medical device studies are highly operational. A strong protocol is important, but success also depends on selecting capable sites, enrolling the right patients, controlling product and clinical workflows, capturing reliable safety and performance data, and maintaining traceable, submission-ready documentation.

A general CRO may understand clinical trials, but diagnostics and medical device studies require specialized execution.

As a diagnostics and medical device CRO, Dynamill Research supports sponsors with:

  • Diagnostic and medical device study design and protocol development
  • Clinical operations aligned to the intended marketing pathway 510(k), De Novo or PMA conducted under an IDE (21 CFR 812), or under an IDE-exempt design where 21 CFR 812.2(c) applies.
  • Site feasibility and investigator selection
  • Endpoint planning: safety and effectiveness endpoints for therapeutic devices (21 CFR 860.7); analytical and clinical performance endpoints sensitivity, specificity, precision, limit of detection and interference for IVDs.
  • Comparator and reference method selection, predicate benchmarking, biospecimen chain of custody, device accountability records (21 CFR 812.140), and central or core laboratory coordination.
  • EDC, CTMS, and live dashboard visibility
  • Risk-based monitoring and sponsor oversight under 21 CFR 812.40 and 812.46, with independent data quality review, and GCP oversight
  • Clinical study reports, IDE progress and final reports (21 CFR 812.150), and analytical and clinical performance summaries prepared for submission.

Our model is built for diagnostics and medical device innovation, not cookie-cutter pharma.

IVD & Medical Device CRO Services We Provide

Clinical Study Design and Protocol Support

Dynamill Research helps sponsors design studies around intended use, target population, risk profile, device or specimen workflow, comparator or control strategy, safety and performance endpoints, and regulatory expectations.

We support:

  • Protocol development
  • Study design consultation
  • Inclusion and exclusion criteria planning
  • Endpoint selection for safety, performance, effectiveness, and usability
  • Sample size and feasibility input
  • Visit schedule and workflow planning
  • Risk-based monitoring strategy
  • Study documentation planning

Our goal is to help sponsors avoid unnecessary delays, amendments, and operational gaps before the study begins.

FDA-Ready Diagnostics and Medical Device Clinical Trial Planning

Diagnostics and medical device sponsors may need evidence to support 510(k), De Novo, PMA, IDE, or other regulatory and lifecycle strategies.

We support sponsors by helping translate regulatory requirements into practical study execution plans, including:

  • Intended use, indications for use, and claims alignment
  • Comparator, predicate, control, and performance benchmark planning
  • Clinical safety, performance, and effectiveness evidence
  • Site readiness
  • Source documentation strategy
  • Inspection-ready trial files
  • Data quality controls
  • Final report readiness

When regulatory strategy and clinical operations are aligned early, sponsors can move forward with greater confidence.

Site Selection and Investigator Network Support

The right site is not just a site that can enroll. It is a site that can execute the protocol correctly.

Dynamill Research supports precision site and investigator selection for diagnostics and medical device studies. We evaluate sites based on patient access, relevant clinical expertise, device and diagnostic workflow, equipment and training needs, specimen handling, staffing, documentation quality, and study-specific feasibility.

Our site selection process considers:

  • Access to the intended patient population
  • Device, procedure, and diagnostic workflow compatibility
  • Equipment, product accountability, laboratory, and specimen handling capability
  • Comparator, control, and follow-up feasibility
  • Investigator experience
  • Start-up timelines
  • Enrollment potential
  • Protocol compliance readiness

Comparator, Device, and Procedure Oversight

Comparator selection, investigational device control, and consistent procedural execution are critical to credible diagnostics and medical device evidence.

If testing, device use, procedures, follow-up, or documentation are inconsistent, the study's safety, performance, or effectiveness evidence can be weakened.

Dynamill Research helps sponsors manage these critical workflows with clear plans, training, documentation, oversight, and issue escalation.

We support:

  • Comparator, device, procedure, and control workflow planning
  • Reference method, predicate, and control coordination
  • Site, investigator, lab, and sponsor communication
  • Device accountability, procedure completion, and result tracking
  • Discordant results, device deficiencies, and safety event escalation support
  • Clinical, device, laboratory, and data reconciliation
  • Documentation quality review

Strong operational oversight helps protect the credibility of diagnostics and medical device study results.

Biospecimen, Device Logistics, and Core Lab Coordination

Studies can be compromised by incorrect specimens, delayed processing, incomplete labels, temperature excursions, weak chain of custody, uncontrolled device inventory, incomplete training, device deficiencies, or inconsistent procedural execution.

Dynamill Research supports biospecimen, investigational device, and core lab coordination, including:

  • Specimen collection and device-use workflows
  • Sample labeling and device identification requirements
  • Storage, shipping, device distribution, and return planning
  • Chain-of-custody and device accountability processes
  • Lab coordination
  • Sample, device, and inventory reconciliation
  • Specimen deviations, device deficiencies, and accountability issue tracking
  • Core lab, depot, and site communication

This is especially important for molecular and infectious disease diagnostics, oncology and companion diagnostics, point-of-care tests, implantable and non-implantable devices, surgical technologies, ophthalmic devices, digital health products, and combination workflows.

Real-Time Study Visibility

Sponsors should not have to wait until the end of the study to discover operational issues.

Dynamill Research uses transparent oversight tools, including CTMS/EDC systems, live dashboards, and proactive communication to help sponsors see what is happening during the study.

We track:

  • Enrollment progress
  • Site performance
  • Data entry status
  • Query trends
  • Specimen, device, and procedure status
  • Comparator, control, and follow-up progress
  • Protocol deviations
  • Monitoring findings
  • Study risks and action items

Real-time oversight allows sponsors to make decisions earlier and reduce avoidable study delays.

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Who We Support

Dynamill Research supports diagnostics, IVD, and medical device sponsors including:

  • Diagnostic test developers
  • IVD companies
  • Molecular diagnostic companies
  • CLIA waiver and Dual 510(k)/CLIA Waiver study design, including untrained-operator and flex studies.
  • Companion diagnostic (CDx) developers, including drug and device co-development programmes running alongside a therapeutic IND.
  • AI-enabled diagnostic companies
  • Medical device companies across Class I, II and III and all clinical specialties.
  • Digital health, software as a medical device, and digital diagnostic companies
  • Clinical laboratories and laboratory instrument developers.
  • Emerging health technology innovators

Whether you are preparing for a feasibility, first-in-human, pivotal, clinical performance, usability, post-market, comparator, or FDA-ready evidence program, Dynamill Research can support your next step.

The Dynamill Difference

Diagnostics and IVD's First
We are built for diagnostics, IVDs, medical devices, digital health products, and AI-enabled technologies. Our model is not repurposed from traditional pharma CRO operations.
Lean and High-Touch
You work directly with experienced clinical research professionals who understand your study, your timeline, and your regulatory goals.
Faster Site Start-Up
Our curated investigator network and feasibility-driven approach help accelerate study start-up while protecting quality.
Transparent Oversight
Live dashboards, proactive communication, and clear reporting help sponsors stay informed at every stage.
Regulatory Readiness
Studies conducted to ISO 14155:2026 for medical device investigations and ISO 20916:2019 for IVD clinical performance studies.
significant / Non-significant risk determination
Significant risk / non-significant risk determination (21 CFR 812.3(m)) and IDE strategy, including abbreviated and exempt pathways.
IRB submission
IRB and ethics committee strategy, informed consent design under 21 CFR 50, including consent considerations for left-over and de-identified specimens.

Our IVD & Medical Device CRO Process

Why Choose Dynamill Research as Your IVD & Medical Device CRO?

Diagnostics and medical device studies demand speed, precision, strong operational control, and regulatory clarity. Dynamill Research brings these together through a CRO model designed specifically for diagnostics and device innovation.

Sponsors choose Dynamill Research for:

  • Diagnostics and medical device-specific clinical operations
  • Senior-level engagement
  • Faster and smarter study start-up
  • Strong site and investigator networks
  • Comparator, biospecimen, device accountability, and procedural oversight
  • Real-time study dashboards
  • FDA-ready documentation support
  • Transparent communication
  • Practical, sponsor-focused execution

We work as an extension of your team, focused not only on getting studies done, but on getting them done right.

If your company is preparing for a diagnostics, IVD, or medical device clinical study, Dynamill Research can help design, execute, and oversee a program that supports regulatory, clinical, and commercial decision-making.

Ready to Plan Your Diagnostics or Medical Device Clinical Study?

Contact Us

  +1877- DYNAMILL (3962 6455)


Our Location

16W285 83rd St. STE D-1 Burr Ridge, IL 60527

Email

info@dynamillcro.com

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    Frequently Asked Questions

    A diagnostics and medical device CRO is a clinical research organization with specialized expertise in studies for diagnostic tests, IVDs, medical devices, software as a medical device, point-of-care technologies, and related health technologies.

    A diagnostics and medical device CRO focuses on intended use, device safety and performance, comparator or control strategy, specimen and product workflows, usability, traceability, and regulatory-ready evidence. Pharma CROs typically focus on drug safety, efficacy, dosing, and therapeutic outcomes.

    A sponsor should involve a CRO before the protocol is finalized. Early involvement helps align study design, endpoints, site feasibility, device or specimen workflows, budget, timelines, and regulatory expectations.

    Dynamill Research supports IVD and diagnostic clinical performance studies, comparator studies, AI validation studies, medical device feasibility and pivotal studies, usability and human factors studies, software and digital health studies, and post-market clinical evidence programs.

    These controls help ensure the investigational product is evaluated against an appropriate reference method, predicate, control, or clinical standard and is used consistently. Weak planning or execution can undermine the final evidence package.

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