Regulatory Expertise

Regulatory Expertise
Product Description

Health Clinical Research is regulated differently across countries, major regulatory bodies such as the EU Commission and FDA continuously update and change legislation associated with conducting clinical trials. However, ICH GCP Standards are unique in bringing together the regulatory authorities as well as the industry requirements. Their mission is to ensure safety, effectiveness and high-quality treatments within the clinical studies.

Medical Association Guidelines and Ethical principles such as The Helsinki Declaration which is prepared in line with WHO policies and guidelines (international and /or national) play a key role in our regulatory process. 

At Atlantia, we take into consideration the regulatory environment of the sponsor company to provide a highly compliant clinical research from the study design through to reporting. Our regulatory services include ethical submissions and approvals as well as the main health agencies health claims submissions 

Atlantia Clinical Trials

  • IE
  • 2017
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service
Specifications
  • Supplied from
    Ireland; United States

Atlantia Clinical Trials

  • IE
  • 2017
    On CPHI since
  • 100 - 249
    Employees
Company types
Contract Service

More Products from Atlantia Clinical Trials (4)

  • Clinical Trial Conduct & Management

    Product Clinical Trial Conduct & Management

    Prior to the conducting of the clinical trial, the study must be approved by the Research Ethics Committee. Then a Site Initiation Visit (SIV) will be performed and the clinical staff (Medical Doctor, Research Nurses, Clinical Trials Assistant, Nutritionist, Research Technician etc.) will be...
  • Clinical Trial Design

    Product Clinical Trial Design

    Study design is a significant phase of any clinical research project. At Atlantia we feel that our careful planning and guidance to our clients coupled with our extensive experience with regulation, pre diseased and diseased populations, is what brings our clients back time and again to trust us with their...
  • Clinical Trial Reporting

    Product Clinical Trial 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.Atlantia maintains no rights to Intellectual Property generated from this study...
  • Clinical Trials Services

    Product Clinical Trials Services

    At Atlantia our expert research team provide a range of services to carry out clinical trials for Medical Food products. Atlantia’s team of qualified professionals has extensive experience in carrying out clinical trials on many different substrates across many different health areas such as Digestive heal...

Atlantia Clinical Trials resources (2)

  • News State-of-the-art Chicago-based clinical site

    This article will briefly discuss the many benefits of conducting a multi-centre human clinical trial, while also touching on the industry leading capabilities and processes of Atlantia Clinical Trials.
  • Video What's the regulatory landscape for OTC products in Europe?

    Nutraceuticals and over-the-counter (OTC) products are regulated by EFSA. The European Food Safety Authority (EFSA) states that human intervention studies are ‘central’ to health claim substantiation and are also the ‘top of the hierarchy’ that informs decisions. Just how much data is necessary to deliver a positive health claim opinion and what can we learn from tracking past published opinions of EFSA’s NDA Panel. What are the key deliverables for any human intervention study or package of human studies?

    The key takeaways:
    Health claims may not be quite as challenging to achieve as some people may think - as long as you design and deliver a consistent package of good quality human intervention studies. Published scientific opinions from EFSA’s NDA Panel covering previous health claim applications offer a great resource to future health claim applicants. The principle of GCP (Good Clinical Practice), is vital to delivering a study that will meet the expectations of EFSA reviewers.


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