Activities - Health studies
Serving its tasks, Biognosis has the capacity to conduct and support carefully organized clinical studies on novel products and nutritional supplements, pursuing the most contemporary design at all levels of a trial setting carefully all necessary clinical studies milestones.
A clinical study is a complex project with many anticipating potential issues, need for effective planning, budgetary and timeline considerations demanding open communication and collaboration with all partners.
Planning and executing a clinical study that achieves a project’s goals requires strong management and strategic oversight at different stages, as:
A. Setting goals and timelines
A carefully created proposal scenario leads to the correct determination of study objectives. A good proposal is a detailed and transparent proposal including wisely chosen endpoints, duration and estimated number of subjects.
B. Proposal’s start-up
The start-up phase is a rather intensive period, describing study design and procedures to be followed, preparing of all necessary documents and leading to the finalization of the working protocol including:
Site selection: The correct choice of site will lead to the correct choice of necessary volunteer numbers and the use of correct inclusion/exclusion criteria for the selected population.
Ethics and regulatory: In this phase for the proposal’s finalized protocol and ethics assessment are submitted to relevant regulatory authorities. They review the study’s scientific background and justify proposed safety/ethics for subjects.
C. The study
Study initiation: ensuring the product has been sent to the site, and all approvals are in place prior to initiating.
Subject recruitment: During the study period, subjects are screened, eligible subjects are registered and subject visits begin. Recruitment continues until the last visit of the last volunteer has taken place. This is the official end of the study period phase.
Study end: Is the time for the correct data management and statistical analysis. When all data entered, reviewed and checked, for transparency reasons the database can be locked. The appropriate statistical analysis will be followed by the report after one round of revisions.
We conduct each trial according to a comprehensive plan, or protocol outlining the:
- types of volunteers who can enter the trial
- schedule of procedures, dosages, and tests
- length of the study and the results to be measured
- necessary follow up and the type of information to collect
- adequate marketing approval
Clinical studies can unlock incredible market opportunities for products and dietary supplements. Studies are performed in human volunteers to provide important information, on how a treatment improves quality of life, as well as its cost-effectiveness and its clinical value.
Consequently, companies aiming to gain access to new markets, or support unique claims, valuate a lot of a trial with the right design, able to recruit enough subjects and meet budget and timeline goals.