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 regulatory services

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

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

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.

Contact UsLearn More

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.

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.

Clinical trial regulation

EFSA & FDA Health claim assistance

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.

Our Process

Our Clinical Trial Process


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.

Execution - Inbound X Webflow Template

Trial Regulation

Our regulatory services include ethical submissions and approvals as well as regulatory compliance with global health agencies.

Growth & Scale - Inbound X Webflow Template

Study Recruitment

Atlantia offers a proven ability to meet recruitment milestones of healthy, pre-diseased and diseased participants. 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.

Growth & Scale - Inbound X Webflow Template

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.

Growth & Scale - Inbound X Webflow Template

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.

Growth & Scale - Inbound X Webflow Template

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.

Get in touch!

Our team can guide you. Schedule a meeting with our research experts to discuss your clinical research program today.

Video camera endoscopy (VCE) clinical trial

The results speak for themselves

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.

Danisco : logo
Unilever: logo
Aker Biomarine: logo