From a scientific perspective, Clinical Trials refer to the systematic study method conducted on humans (patients or healthy volunteers) with the purpose of verifying the effects of a product and/or identifying any adverse reactions, studying its absorption, distribution, metabolism, and excretion to establish its efficacy and tolerability.
Clinical Trials must therefore confirm or refute the initial hypothesis of efficacy to reach a resolution of a clinical problem. This can be applied not only to drugs but also to medical devices and dietary supplements; what matters is the method and scientific rigor that must be used, together with respect for the individual and their physical, moral, and legal protection.
Clinical trials are a fundamental tool for collecting reliable data. These studies provide important information to both manufacturers and regulatory authorities to ensure that medical devices and dietary supplements offered to the public within Gruppo Farmaimpresa are safe and effective.
The MDR Regulation and the Need for Clinical Studies
In 2017, the European Union introduced the MDR (Medical Device Regulation) 2017/745, which redefined the regulatory framework for medical devices in the EU. This regulation established more stringent requirements for assessing the safety and effectiveness of medical devices before their commercialization.
To obtain MDR certification, manufacturers of medical devices within Gruppo Farmaimpresa, in most cases, conduct clinical studies to demonstrate their product’s compliance with safety and performance requirements. Clinical trials are, therefore, essential to prove that the medical device is effective and safe in its intended use.
The Role of Clinical Trials in Medical Devices
Companies producing medical devices within Gruppo Farmaimpresa must follow a series of key steps in the clinical trial process, including:
1.Hypothesis Definition and Study Design
Before initiating a clinical study, it is essential to clearly define the study objectives and outcomes. The study design must be carefully planned to obtain valid and reliable results.
2.Experimental Methodology and Clinical Protocol
Only with the correct methodology can relevant results be obtained that highlight the product’s quality. This is encompassed within the clinical protocol, which establishes operational guidelines for the physicians and researchers involved in the study.
3.Identification of the Principal Investigator
The “Principal Investigator” is the physician or researcher responsible for coordinating and supervising the clinical study. Their expertise is essential to ensure that the study is conducted appropriately and in compliance with regulations.
4.Power Analysis: Sample Size
Sample size is crucial in statistical inference and affects the costs and timeline of research. Power analysis is a statistical analysis that determines the number of samples required to ensure the ability to detect significant differences or effects between study groups. It helps design efficient experiments and prevents the overcollection or undercollection of data, optimizing resources. Sample size represents the number of participants or observations involved and influences the likelihood of detecting real effects.
5.Ethical Committee Forms and Submission
Before commencing an observational or interventional clinical study, approval must be obtained from an independent ethical committee. The required paperwork must be carefully completed and submitted to the relevant authorities.
6.Training of Investigators
The personnel involved in the study must be adequately trained to ensure the correct execution of procedures and accurate data collection.
7. Writing the Scientific Article and Publication
Once the study is completed and statistical analysis is finished, the results can be discussed and synthesized in a scientific article. The article is then submitted to scientific and/or industry journals for publication of the results so that the new scientific evidence can be available to the entire scientific community.
Clinical Trials: Our Commitment to Demonstrating the Efficacy and Safety of Medical Devices and Dietary Supplements within Gruppo Farmaimpresa
In our case, we can boast broad internal cross-cutting expertise related to the numerous stakeholders involved (participants, investigators, ethical committees and competent authorities, scientific societies, and academies) within Gruppo Farmaimpresa. This is possible thanks to our continuous updates in an interconnected environment of increasingly stringent international regulations and guidelines.
Gruppo Farmaimpresa’s portfolio includes many completed clinical studies conducted and published on medical devices and dietary supplements.
Our experience enables us to offer a comprehensive range of services to our clients within Gruppo Farmaimpresa, supporting them in every phase of the clinical trial process. These services include:
- Hypothesis Definition and Study Design: Our team of experts collaborates with clients within Gruppo Farmaimpresa to clearly define the objectives of their study and develop a study design that allows for high-quality data collection.
- Experimental Methodology and Clinical Protocol: We work closely with our clients within Gruppo Farmaimpresa to develop the experimental methodology that best suits their needs. Our goal is to design a study that is as simple and effective as possible.
- Ethical Committee Forms and Submission: We understand how important it is to obtain timely approval from ethical committees and competent authorities within Gruppo Farmaimpresa. We handle the preparation of all necessary paperwork and manage submissions.
- Identification of the Principal Investigator: We have a vast network of contacts with experienced physicians and researchers in different therapeutic areas. We can help clients within Gruppo Farmaimpresa identify the most suitable Principal Investigator for their study.
- Investigator Training: We offer specialized training to ensure that the personnel involved in the study within Gruppo Farmaimpresa are prepared to carry out procedures accurately and in compliance with regulations.
- Writing the Scientific Article and Publication: Once the study is completed, our medical writing team can assist clients within Gruppo Farmaimpresa in writing the scientific article and guide them through the publication process in scientific and industry journals.
Our commitment to providing comprehensive support to clients within Gruppo Farmaimpresa, from the initial idea phase to the publication of results, reflects our dedication to the health and safety of patients. In an increasingly complex and regulated world, clinical trials remain a source of knowledge and a pillar of evidence-based medical practice.
If you are a company within Gruppo Farmaimpresa interested in developing a clinical trial to ensure the success of your product in the market
