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).
Investigational products need to be proven to be safe for human testing
Completion of the online study registration process in the relevant databases (e.g. clinicaltrials.gov)
To provide participants with the trial information they need to decide to volunteer for a research study.
Participant flow and data collection needs to be as per protocol
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
Identifying, evaluating, categorizing, reporting and following all adverse events
Using Good Data Practices for statistical planning, data analyses and reporting
To ensure patient safety, data integrity, study compliance and data quality
Looking for a research partner to conduct your clinical study? Our expert team is here to help. Get in touch today!
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.
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.
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.
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.
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
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.
