Clinical data is central to what we do: Biosamples are analysed to yield data which is then transferred to our biostatistics team whereby the data is analysed to generate a statistical study report. A clinical study report can be generated if so desired.
Many studies look at the impact of diet on the condition being researched.
We commonly analyse fecal, skin, vaginal and oral microbiome, using state of the art techniques.
Biomarkers vary dramatically and are specific to different health areas, such as immunity, cardiovascular or endocrine. We commonly collect blood, fecal, urine, skin and saliva for biomarker analysis.
Many trials include questionnaires or scales such as Quality of Life (SF36), Gastrointestinal health (GSRS), etc.
The final element of a clinical study is the statistical analysis which generates the statistical report through the use of mathematical tools.
Certain measurable outcomes require tools such as cognitive battery tests, DXA scans, MRI, BP monitoring, etc.
The Atlantia team is comprised of nutritional scientists who are trained and experienced in administering validated Food Frequency Questionnaires, 3-day Diet Diary, 24-hour dietary recalls, and instructing volunteers on how to complete weighed/non-weighed food diaries. Atlantia uses specialised software to generate data on both macro-nutrient intakes and an extensive breakdown of micro-nutrient intakes. The Atlantia team has the expertise to recommend a bespoke plan to ensure the most relevant and accurate dietary data is collected for your unique study.
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 microbiome services, including but not limited to:
• Shotgun analysis
• Library preparation
• Data analysis
• De Novo 16-Sequencing of Genomes
• Transcriptome Assembly
• Functional Genomics
• Re-Sequencing of Genomic Fragments
• Re-Sequencing of Genomes
• Standard and Custom Library Generation
• Project Design
• Bioinformatics and Metabolomics
The Atlantia team along with several biostatisticians with expertise in a wide range of health areas, are able extract and analyse data from the electronic data capture system. A statistical analysis plan is tailored to the sponsors study to ensure the most accurate analysis of primary, secondary and/or exploratory outcomes is conducted.
The Statistician will prepare and finalise the Statistical Analysis Plan (SAP), including mock tables, which will be signed by the sponsor, in advance of database lock. Once the database is locked, the statistician will perform the statistical analysis and provide a draft of the Tables, Figures, Listings (TFLs) for review. The dataset will be available on SPSS, Excel Compatibility or CSV formats. Once approved by the sponsor a final version will be issued.
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 as well as regulatory compliance with global health agencies.
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.
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.
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.
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.
Our team can guide you. Schedule a meeting with our research experts to discuss your clinical research program today.
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.
