Clinical trial design

Clinical Trial Planning and Design Experts

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 scientific team works in accordance with ICH GCP Standards, Regulatory agency guides, Medical Agencies Guidelines, Ethical principles and peer-to-peer journals.

Clinical trial design

What’s involved in study design?

Clinical trial budget

Many types of clinical trials can yield scientifically valid results. We provide you with a detailed breakdown of the study budget based on your requirements.

Preliminary research

We help you to understand what research has been completed up to date, with regards to your product and health area of interest.

Study feasibility

​Our expert team will work to assess the study feasibility in accordance with ICH GCP Standards, ethical principles, regulatory and medical agency guidelines, your budget and the preliminary research.

Power calculation

Studies designed by our team ideally include a statistical calculation to estimate how many participants are needed in the trial in order to gather significant results.

Clinical trial protocol development

We develop a comprehensive plan with the input of our multidisciplinary experts and the sponsor. This document will be the main guide for all the trial activities.

Study document preparation

Clinical trial documentation includes the eCRF (electronic Case Report Form), source documents, Trial Master File (TMF), study logs and study specific Standard Operating Procedures (SOP’s).

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Protocol development in clinical trials

The study protocol developed by our team includes:

• Background information about the research topic and the investigational product;

• A comprehensive description of the objectives, duration of the study, the population, inclusion and exclusion criteria;

• The randomisation, blinding and treatment allocation, as well as the unblinding procedure if applicable;

• Investigational product formulation, packaging, labelling, handling, dosage and compliance;

• Procedures such as recruitment, screening, eligibility, visits, measurements, assessments and sample collection protocols;

• Data processing, statistical considerations, confidentiality and monitoring methods;

• Reporting and publication agreements;

Apps for clinical research

Atlantia has developed a number of customised Apps to collect daily data on subject’s symptoms, compliance and AE reporting.  A profile screen can let participants edit data that can change during the course of the study, such as weight. The profile screen is also used to give participants an easy way re-visit on-boarding screens, contact help & support and to view any consent/privacy policies associated with the study.

  • Customisable apps: the look and feel (branding, colours logo etc.) can all be personalised - as part of the development process, the optimal UI and UX for each study will be taken into consideration.
  • Push Notifications: The Apps will also feature Local & Remote Push Notifications - To keep study participants on track and engaged, a local push notification in the App that would appear at a set time each day if the user has not yet completed the survey. Additionally, via the Admin Portal, a push notification can be generated to a study participant - either manually or following a set of rules.
  • Syncing Data: data is  stored in local encrypted device backup, and this can also be retrieved manually should it be required (e.g. on a visit date) for audit purposes.

Clinical trial design
Our Process

Our Clinical Trial Process


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.

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Trial Regulation

Our regulatory services include ethical submissions and approvals as well as regulatory compliance with global health agencies.

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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.

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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.

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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.

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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

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