Clinical

No matter what stage of clinical development you are in, trust the experts at EMMA International to ensure complete GCP compliance of your clinical trials and activities.

From developing early-stage clinical strategies, to monitoring and analysis of clinical trials and data, the experts at EMMA have supported a variety of complex therapies and devices through the clinical development process.

Our clinical consulting services include:

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Regulatory Submissions applicable to clinical trials (IND, IDE, Pre-BLA)

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Clinical Strategy Development

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Medical Writing

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IRB Applications and Management

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Informed Consent and Investigator Brochure Writing

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Clinical Trial Protocol Authoring, including advanced biostatistical methods

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Project Management of Clinical Trial Sites

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Site Monitoring and GCP Audits

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Data Analysis and Management

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GCP Training

From study development to closeout, we offer clinical support to streamline processes, monitor progress, and address challenges proactively. With EMMA International’s clinical consulting services, you can rest assured that your product will move seamlessly through the clinical development process to commercialization.

Ready to learn more about EMMA’s Clinical and GCP Compliance services? Connect with our clinical experts at 248-987-4497, info@emmainternational.com, or click the link below.

Ready to learn more about working with us?

Clinical Resources

The IND Process: An Overview

The IND Process: An Overview

Prior to drugs being commercially available, manufacturers often conduct pre-clinical studies to obtain data ...

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