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Clinical Trial Regulation

We Understand the Regulatory Framework of Your Study

Our regulatory team take into consideration the regulatory environment of the sponsor company to provide highly compliant clinical research from the study design through to reporting.

Clinical Trial Regulation
Clinical Trial Regulation

Clinical Trial Regulatory Services

Regulation Research

Regulation Research

We help you to understand what regulatory considerations are important when designing the trial and guide the trials registration process.

Ethics In Clinical Trials

Ethics In Clinical Trials

The Atlantia Scientific Team will prepare and submit the application to the Independent Ethics Committee or Institutional Review Board on the sponsors behalf.

Claim Application

Claim Application

We maintain full compliance within EU & USA regions to gain clinical trial approval for sponsor companies. We can help with the dossier preparation, submission and application management.

Regulatory Bodies in Clinical Trials

Atlantia operates within the regulations of EU standards in accordance with EFSA. We operate to ICH-GCP standards and can help companies with novel food applications, EFSA dossiers, or research statements falling within the advertising standards association (ASA). Atlantia operates within the remit of FDA also. We can help with GRAS applications, NDIs, Structure Function Claims as well as Qualified Health Claims. We understand the various regulations between Europe and the USA and maintain full compliance within both regions to gain clinical trial approval for sponsor companies.

Regulatory Bodies in Clinical Trials
Discuss Your Project
Take the First Step

Discuss Your Project

Looking for a research partner to conduct your clinical study? Our expert team is here to help. Get in touch today!

Regulatory Bodies In Clinical Trials

Clinical Research is regulated differently across countries, regions and amongst major regulatory bodies such as the EU Commission and FDA who continuously update and change legislation associated with conducting clinical trials. Their mission is to ensure safety, effectiveness and high-quality treatments within the clinical studies.

Regulatory Bodies In Clinical Trials
Our Process

Our Clinical Trial Process

Clinical Design

01. Clinical Design

Study design is a significant phase of any clinical research project. At Atlantia we can plan and guide you to design a successful trial depending on your focus: to increase sales, to obtain a health claim or as a proof of efficacy.

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Trial Regulation

02. Trial Regulation

Our regulatory services include ethical submissions and approvals, our team takes into account the regulatory environment of the sponsor company to provide highly compliant study design.

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Study Recruitment

03. Study Recruitment

Atlantia offers a proven ability to meet recruitment milestones. We have access to populations of all age groups and we are experienced in recruiting populations from 20 to 600 participants per trial on budget, and on time.

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Study Conduct

04. Study Conduct

Our unique model maximises control, reduces the risk of data inconsistency, and brings a sense of assurance to our clients dealing with one competent organisation as opposed multiple contract research organisations.

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Trial Analysis

05. Trial Analysis

At Atlantia your clinical data is at the centre of our service. When the samples are collected either during study visits or remotely they are prepared and stored at our facilities at -80*c, -20*C or refrigerated temperature and analysed by our research partners.

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Study Reporting

06. Study Reporting

The Atlantia Clinical Research team provides a comprehensive study reporting service. Our statisticians adhere to ICH-GCP standards to produce a statistical study report, and if the client requests, a full clinical study report.

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EC & IRB Submissions

The study will not begin until the IEC has approved of the protocol and the subject consent form along with any advertisements, diaries and instructions to the subjects, if applicable. The IEC approval will be documented in writing to the investigator.

A Research Ethics Committee is the acknowledged international best practice structure for overseeing the conduct of ethical standards in healthcare research. An application will be submitted to the Ethics Committee for approval of the study, prior to study starting. The Atlantia Regulatory team will prepare and submit the application to Ethics Committee on the sponsors’ behalf.

Media & Resources

More From Atlantia

Case Studies

Case Studies

Our team has put together these clinical trial case studies in multiple topics to help you understand how we have assisted other sponsors in the past to tailor their clinical research programs.

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Latest News

Latest News

Learn more about our company through our latest news. Articles have been worked on by members of our team. For media inquiries, please reach out to: marketing@atlantiatrials.com

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Publications

Publications

Many of our clinical studies conducted are translated to published research papers in some of the top nutrition journals. You can discover our latest published work under this section.

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