Clinical Trials R&D Tax Credits

Innovate your clinical trial operations and verification science. Sponsors, contract research organisations (CROs), biotech and pharma companies across the U.S. are consistently designing new protocols, digital patient‑engagement workflows, decentralised trial models and analytics‑driven endpoints. Many of these initiatives satisfy the criteria for the federal R&D Tax Credit under IRC §41 (and often corresponding state‑level credits).

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Examples of qualifying activities in clinical trial operations

Protocol & Design Innovation Developing adaptive trial arms, decentralised site models, novel biomarker or digital‑endpoint tracking, side‑by‑side validation of alternative designs.
Digital Monitoring & Data Capture Integrating wearable sensors, remote monitoring platforms, e‑CRF upgrades, real‑time analytics for patient‑data streams, patient‑engagement apps.
Analytics & Simulation Developing or validating patient‑stratification algorithms, recruitment‑simulation models, predictive retention modelling, subgroup‑analysis methodologies.
Recruitment & Retention Experiments Testing new digital‑engagement workflows, remote consenting platforms, decentralised trial recruitment pilots, side‑by‑side conversion rate comparisons.
Regulatory Submission Support & Emerging Modalities Piloting trials for new therapeutic modalities (gene therapy, advanced biologics), creating analytics and monitoring workflows for novel endpoints, conducting side‑by‑side comparator studies.
Quality, Risk & Trial‑Operations Optimisation Automating monitoring workflows, predictive risk monitoring, side‑by‑side manual vs automated monitoring trials, pilot runs of adaptive data‑flow architectures.

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What qualifies as R&D in Clinical Trials?

To qualify, your clinical trial activities must:

Aim at a permitted purpose — such as a new or improved trial design, adaptive randomisation strategy, digital‑patient monitoring system, or novel endpoint analytics.
Tackle technical uncertainty — for example: “Will this AI‑driven patient‑recruitment algorithm achieve statistically meaningful enrichment?”, “Can the remote‑monitoring sensors maintain valid data integrity across sites?”, “Can an adaptive arm safely reduce cycle‑time while still meeting regulatory acceptability?”
Use a process of experimentation — pilot cohorts, side‑by‑side arms, simulations of recruitment/retention, successive protocol refinements, system integrations and analytic benchmarking.
Be technological in nature, grounded in biostatistics, data science, clinical pharmacology, regulatory science, sensor/telehealth engineering or trial operations engineering.

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Qualified Research Expenses (QREs)

Expense Type

Examples in Clinical Trials

Eligibility Notes

Wages

Clinical scientists, biostatisticians, data managers, trial‑tech engineers

Direct, supervisory or support personnel performing qualified research tasks

Supplies

Sensor modules, patient‑monitoring kits, trial‑platform licences, prototype digital tools

Materials/consumables consumed in the experimentation or trial environment

Software / Cloud

Analytics platforms, simulation tools, e‑CRF upgrades, remote‑monitoring software

Eligible when used to support the qualified research

Contract Research

CRO costs for pilot cohorts, external analytics vendor contracts, digital‑platform vendors

Subcontracted research generally up to applicable percentage of cost qualifies

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Roles commonly involved in qualifying activities

Principal Investigators, Clinical Scientists, Biostatisticians
Data Scientists, Analytics Engineers, Digital‑Patient‑Engagement Specialists
Study Operations Managers, Trial Coordinators, Recruitment/Retention Specialists
Sensor/Device Engineers, Telehealth Platform Engineers
Regulatory/Clinical‑Operations Engineers, Pilot‑study/benchmark‑study Leads

What does not qualify

Routine trial execution or site monitoring under established protocols without innovation or experimentation
Standard patient‑recruitment or data entry operations that do not involve new methods or technical uncertainty
Sales, marketing, general management, administrative tasks
Land acquisition, standard site build‑outs or capital improvements not tied to a documented research/experiment process

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Compliance and Documentation

§174 Update

Following the One Big Beautiful Bill Act (OBBBA) signed July 4, 2025, §174 now allows immediate expensing of domestic research expenses for tax years beginning on or after January 1, 2025. Taxpayers may also elect optional amortization under new §174A. Foreign research expenses must still be amortized over 15 years. This is separate from the §41 credit but impacts overall tax planning.

The regulatory environment for R&D requires robust documentation. Key records include:

Protocol briefs, design hypotheses, versions and amendments reflecting experimentation and iteration
Pilot‑run logs, recruitment/sensor/data‑platform trial summaries, side‑by‑side comparisons of alternative methods
Analytics simulation reports, model‑validation logs, sensor/data‑capture performance comparisons
Time‑tracking records for R&D staff and trial personnel, payroll tied to research activities
Materials/consumables logs consumed during trial pilots, device/test‑kit consumption, iteration logs Even “failed” trials, abandoned designs or iteration logs provide evidence of experimentation. These records support the four‑part test for R&D: permitted purpose, technical uncertainty, process of experimentation and technological nature.

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Frequently Asked Questions

Do sponsors, CROs or biotech companies qualify for the R&D Tax Credit in the context of clinical trials?

Yes — if they design or pilot new trial protocols, digital or sensor‑enabled monitoring systems, adaptive trial designs, or novel data‑analytics workflows rather than simply executing standard trials.

What types of expenses can be claimed?

Wages of scientists/engineers involved in research activities; consumables or materials used in pilot study/monitoring kits; software/cloud platforms used in analytics or monitoring; third‑party R&D contracts (e.g., pilot cohorts, analytics vendors).

Which phases or trial activities are eligible?

Activities in Phase I through IV may qualify provided they involve new methods, analytics, digital monitoring, recruitment/retention innovations or process improvements—not just routine trial conduct.

What kinds of activities do not qualify?

Standard trial execution under an established protocol, routine patient‑monitoring without innovation, general operations, marketing, administrative or management tasks.

How should a clinical trial team document their research?

Maintain detailed trial‑design/hypothesis logs, pilot‑cohort trial summaries, data‑platform integration logs, employee time by project segment, material/test‑kit consumption in experimentation, version histories of protocols and monitoring workflows.