Clinical Trial Reporting

Clinical Trial Reporting
Product Description

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. We maintain ownership over procedures and software, but not the data generated. The study reporting phase or close-out phase includes biostatistics analyses and a clinical study report along with a final presentation.

Atlantia Food Clinical Trials Ltd.

  • IE
  • 2017
    On CPhI since
  • 1
    Certificates
  • 50 - 99
    Employees
Specifications
  • Supplied from
    Ireland; United States

Atlantia Food Clinical Trials Ltd.

  • IE
  • 2017
    On CPhI since
  • 1
    Certificates
  • 50 - 99
    Employees

More Products from Atlantia Food Clinical Trials Ltd.

  • 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 updated on all aspects of the study. Our services include subject recruitment and screening, study conduct, electronic data capture, data and quality management and independent study monitoring.
  • 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 scientific validations.

    Our scientific team will work with our sponsors to agree on the most suitable research design depending on the desirable outcomes. We have experience designing acute, bioavailability, observational and interventional studies.

  • 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 health (constipation, IBS, motility, intestinal mucosal damage, use of probiotics/live biotherapeutics) as well as sports nutrition, immunity, metabolic health, weight management, dermatology, cognition, stress, and a host of other areas. Atlantia is ICH GCP compliant and has sites in Cork, Ireland and Chicago, Illinois, USA, at which we are able to recruit patient populations for clinical trials.
  • Regulatory Expertise

    Product Regulatory Expertise

    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 

  • Sample Analysis & Interpretation

    Product Sample Analysis & Interpretation

    All the samples are collected prepared and stored at our facilities at -80*c, -20*c or refrigerated temperature and analysed by our research partners. The most common analyses provided are dietary and microbiota analysis. As a spin out of the APC microbiome Ireland, Atlantia has extensive experience in the microbiota; skin, oral, digestive, vaginal and the newest research, organ microbiota. The human gut microbiota is emerging as a primary focal point for a diverse array of disciplines, principally due to its contribution to health and risk of disease throughout life. We work with specialist partners to provide our clients metabolomic services, including but not limited to

    Shotgun analysisLibrary preparationData analysisDe Novo 16-Sequencing of GenomesTranscriptome AssemblyFunctional GenomicsRe-Sequencing of Genomic FragmentsRe-Sequencing of GenomesStandard and Custom Library GenerationProject DesignBioinformatics and Metabolomics

Atlantia Food Clinical Trials Ltd. resources

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