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ICH GCP Trials

Discover our Good Clinical Practice Expertise

We are a functional service provider for clinical trials, fully ICH-GCP compliant. Clinical trials should be conducted using Good Clinical Practices (GCP) with appropriate Human Subject Protections (HSPs) and all products used in human testing should be produced under Good Manufacturing Practices (GMP) using a well-established Quality Management System (QMS).

ICH GCP Trials
ICH GCP Trials

What is Good Clinical Practice in Clinical Trials?

Safe Products

Safe Products

Investigational products need to be proven to be safe for human testing

Trial Registration

Trial Registration

Completion of the online study registration process in the relevant databases (e.g. clinicaltrials.gov)

Informed Consent Form

Informed Consent Form

To provide participants with the trial information they need to decide to volunteer for a research study.

Recruitment

Recruitment

Participant flow and data collection needs to be as per protocol

Appropriate Trial Designs

Appropriate Trial Designs

Including a comprehensive review of past trials, study objectives, test methods, eligibility criteria, dosing schedules, randomisation methods, performance criteria or endpoints, outcomes and statistical methods

Adverse Events

Adverse Events

Identifying, evaluating, categorizing, reporting and following all adverse events

Statistical Methods

Statistical Methods

Using Good Data Practices for statistical planning, data analyses and reporting

Monitoring And Auditing Trial Activities

Monitoring And Auditing Trial Activities

To ensure patient safety, data integrity, study compliance and data quality

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!

Our Gold Standard Clinical Trials

In any research, whether drug or food, it is important to find a research partner that understands the key differences. These differences will have a large impact in terms of budget and timelines. All clinical trial protocols should clearly define the objectives, inclusion/exclusion criteria, study measurements and statistical analysis. Your research partner should have a diverse expert team capable of executing all study functions to maximize your chance of success.

Our Gold Standard 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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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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