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

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

Trial registration

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

Informed Consent Form

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

Recruitment

Participant flow and data collection needs to be as per protocol

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

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

Statistical methods

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

Monitoring and auditing trial activities

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

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 Process

Our Clinical Trial Process

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.

Execution - Inbound X Webflow Template
02.

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
03.

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
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.

Growth & Scale - Inbound X Webflow Template
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.

Growth & Scale - Inbound X Webflow Template
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.

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
CLINICAL TRIAL Case studies

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