Clinical Research by Deloitte

We are a full-service clinical research organization (CRO) focusing on start-ups and small to large-size MedTech companies. Our goal is to make your medical device or software available for patients faster.

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About Clinical Research by Deloitte

Clinical Research by Deloitte helps MedTech companies accelerate product launches and maximize commercial success. As a clinical research organization we provide strategical clinical and strategical regulatory planning advice, support the full clinical investigation cycle, and help companies simplify complex quality management (QM) and design control. Our digital QM Handbook (QMH) makes it also easier for start-ups to implement their first QM System (QMS).

We are committed to providing our services in the way that is most valuable to our clients. You can strengthen your team with our talent, outsource individual tasks or the entire clinical function to us and focus on your core business.

Clinical Research Offerings

Strategic Clinical and Regulatory Planning

We advise on the development of a lean clinical and regulatory strategy, considering novel/adaptive trial designs to generate the clinical evidence for successful market access and sustainable growth.

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Real-world Data (RWD)

Real-world data provides essential support throughout the product lifecycle, from ideation to post-marketing surveillance.

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Clinical Investigation Plan (CIP)/Bench Tests for SaMD

Following a systematic approach we help you to design a targeted and efficient CIP/Bench Test Plan.

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Execute your clinical investigation

With our experienced team we can support the entire clinical investigation/bench testing and post-marketing clinical follow-up cycle.

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Medical Writing

We create or update documents for your medical device technical file and clinical evaluation and write scientific publications.

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Post-market Surveillance & Post-market Clinical Follow-up

Deloitte helps you plan and execute post-marketing activities that are ideal for your product(s) to generate real-world evidence for decision-making throughout the product lifecycle.

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Digital QMH

Deloitte offers an End-to-End traceable digital QMH, which is based on industry best practices, resulting in elevating regulatory compliance and faster time-to-market.

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Health Economics and Outcomes Research

Deloitte can help shape successful market access and reimbursement strategies for your medical device.

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Clinical Research by Deloitte