Ethical.
Efficient. Expert.

Fast & ethical IRB approvals for your research.

Elemental Institutional Review Board ensures your research meets the highest ethical and regulatory standards with fast, cost-effective reviews. Whether you’re conducting clinical trials for pharmaceuticals, biologics, real-world evidence, wellness products, medical devices, or other innovations, our expert team streamlines the review process so you can move forward with confidence.

With expertise in FDA-regulated research for regulated products and FTC considerations for health & wellness products, we provide thorough, compliant, and ethical evaluations to support your
study’s success.

Why choose Elemental IRB
for your research?

Ethics first,

always

We champion ethical research

and not just tick boxes. Our board prioritizes participant safety, rights, and well-being at every stage, ensuring your study meets the highest ethical standards with

integrity and care.

Expertise

that sets us apart

Not all IRBs understand the nuances of your research, but we do. With dedicated chairs and reviewers for pharmaceuticals, biologics, supplements, skincare, and medical devices, our board brings specialized knowledge to ensure a seamless, informed review tailored to your industry.

Lightning-fast reviews without cutting corners

Deadlines matter, and slow reviews shouldn’t hold you back.

Our proprietary technology accelerates approvals while maintaining meticulous oversight, helping you move from submission to market faster than ever.

Cost-effective

without compromise

Traditional IRBs come with hefty price tags and unnecessary delays. Our streamlined approach is designed for efficiency, offering significant savings without sacrificing quality, compliance,

or ethical rigor.

Radically

transparent process

No guesswork, no surprises. From submission to final decision, we keep you informed at every step, providing clear communication and dedicated support so you always know what’s next. We lead by example, so please check out our pricing page.

IRB oversight and ethical research support for your study

Through our thorough review process, Elemental IRB empowers researchers to conduct ethical, compliant, and meaningful research with confidence. Our expert board ensures your study is not just approved but
set up for success.

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Here’s how we support you every step of the way

Comprehensive protocol reviews

We meticulously assess every detail of your study to ensure full compliance with ethical guidelines, regulatory standards, and best practices, helping you move forward without unnecessary delays.

Informed consent, perfected

Clear, participant-focused consent documents are critical.
Our board refines and evaluates your materials to safeguard participant autonomy and enhance study enrollment.

Proactive study monitoring

Compliance isn’t a one-time event. We provide ongoing oversight, catching potential issues early so you can adapt quickly and keep your study on track.

Seamless protocol modifications

When changes are needed, we guide you through the process to ensure adjustments maintain participant safety, regulatory compliance, and study integrity.

How our IRB review process works

At Elemental IRB, we provide efficient, ethical, and expert-driven reviews for all types of human subject research. Whether your study involves early-phase drug development, pivotal or late-stage clinical trials, real-world-evidence studies, medical devices, or consumer wellness products, our experienced board ensures a thorough, compliant, and streamlined review process so you can focus on advancing your research with confidence.

What types of studies do we review?

Pharmaceutical clinical trials (all phases)

From Phase I safety studies to large-scale, pivotal Phase III and IV trials, our board provides comprehensive IRB oversight to ensure your study meets FDA regulatory standards while prioritizing participant safety and data integrity.

Real-world evidence (RWE) studies

We support real-world evidence research, including post-market surveillance, pragmatic trials, and retrospective data analyses.

Medical device research & trials

Whether you’re conducting pre-market investigations or post-market surveillance studies, we offer specialized IRB review to support regulatory approval and ongoing product evaluation.

Clinical trials for supplements

Testing a dietary supplement, topical formulation, or functional food? Our board brings deep industry knowledge to ensure credible, ethical, and regulatory-compliant research that supports your product claims.

Survey-based & behavioral research

For studies collecting consumer insights, self-reported health outcomes, or behavioral data, we ensure ethical compliance while making the process as seamless as possible.

Observational & longitudinal studies

Tracking health trends, user experiences, or real-world product effects? Our board ensures your study meets ethical and regulatory standards while maintaining scientific integrity.

Interventional & experimental research

Whether testing a new treatment, device, or behavioral intervention, our IRB provides rigorous review to safeguard participants and ensure compliance with ethical and regulatory guidelines.

Other human subject research

From usability studies to biomarker collection and beyond, Elemental IRB supports a wide range of study designs, offering expert guidance, transparent communication, and fast turnaround times.

Our review process:
fast, transparent, and researcher-friendly

Streamlined submission
with built-in efficiency

Submitting your study is simple and secure. Whether through our online portal or via email, our intelligent submission system ensures all required documents, including protocols, consent forms, and supporting materials, are complete and ready for review.

Our technology streamlines this step, reducing back-and-forth and getting
your study into the review queue faster.

Fast, flexible, and expert-driven review

Expedited Review

Minimal-risk studies may qualify for a faster turn-around, allowing you to move forward without unnecessary delays.

Full-Board Review

For more complex research, our expert panel provides

a rigorous, high-quality evaluation, ensuring compliance with ethical and regulatory standards while keeping efficiency

at the forefront.

Ongoing support for every stage of your study

IRB approval isn’t the finish line, it’s just the beginning. We stay engaged throughout the lifecycle of your study, providing:

Rapid review of amendments and protocol modifications to keep your research adaptable and compliant.

Oversight for adverse events and safety monitoring to ensure participant protection.

Guidance through final reporting and study closure to meet regulatory and ethical obligations with ease.

Elemental IRB helps you navigate the entire research process with confidence, speed, and expert support.

Submit your study to
Elemental IRB with confidence

Partner with Elemental IRB for fast, cost-effective, and expert-driven reviews that keep your research moving forward. Whether you’re conducting a pharmaceutical trial, real-world evidence research, medical device study,
or wellness research, our streamlined process ensures ethical compliance without unnecessary delays. With faster turnaround times, transparent pricing, and dedicated support, we help you navigate the IRB
process smoothly, so you can focus on bringing innovations to market with confidence.

IRB oversight across all research areas

Elemental IRB is built to support all types of human subject research, from pharma-ceutical and medical device trials to supple-ments, skincare, and consumer health studies. Our specialized expertise in wellness research sets us apart, but our flexible, researcher-friendly approach ensures fast, ethical, and reliable oversight for studies across industries.

Ethical. Efficient. Expert.