Clinical research is a fundamental step in transforming scientific discoveries into new medicines. Studies involving healthy volunteers and patients provide essential evidence to understand how an investigational treatment behaves in the body, while assessing its safety, tolerability, and potential benefits. As science and technology continue to evolve, so too are the ways clinical studies can be designed and delivered.
At ALL, we believe that the perspectives of study participants should help shape clinical research. Rather than viewing patients solely as recipients of treatment, we seek to involve them as active contributors and listen closely to their experiences, expectations, and challenges. This insight helps us identify opportunities to make studies more relevant, accessible, and participant-friendly.
We are embracing new technologies, innovative research methods, and more flexible clinical trial models to help make participation easier and improve the overall study experience. By incorporating the needs of participants into the design and execution of our programmes, we aim to support more efficient development while maintaining high standards of scientific integrity.
An important part of our approach is inclusive clinical research. We seek to recruit participants who reflect the diversity of the populations that our future medicines are intended to serve. A broader representation of people in clinical studies can provide a more complete understanding of how treatments may work across different groups and help inform the development of medicines designed for real-world patient populations.
Our commitment extends beyond individual studies. We continue to explore better ways of conducting clinical research, working with patients, investigators, communities, and scientific partners to identify effective practices. Through collaboration, innovation, and a strong focus on participant needs, we aim to help shape clinical trials that are more inclusive, meaningful, and capable of delivering better outcomes for patients around the world.
Before a new medicine can be made available to patients, it must undergo a series of carefully designed clinical studies to establish its safety, quality, and effectiveness. These studies generate the evidence needed to support regulatory approval and ensure the medicine’s benefits outweigh its potential risks.
Clinical research is generally divided into four phases. The first three phases are conducted before approval, while Phase IV takes place after approval to continue monitoring the medicine’s safety, effectiveness, and use in a wider patient population.
healthy volunteers
They help researchers to understand how a new drug works in humans and to learn more about what dose should be used in the next phase of studies. Phase I trials are short and volunteers are closely monitored at the research center where the trial is being conducted.
Assess drug safety
Determine the side effects
Evaluate how the drug should be taken
patients
With the condition for which the medicine, device, product or treatment has been developed.
Phase II studies test how safe and effective the study medication is in a group of approximately 100 to 300 patients with the condition for which the medicine has been developed. Several Phase II trials are generally performed to test the drug in different patient groups and at different doses. Patients are closely monitored in Phase II trials but do not need to stay at the research centers.
Assess short-term safety and effectiveness
Find the dose at which the drug works best with the least side effects
Small-scale placebo comparison
patients
Phase III studies are much larger, involving between approximately several hundred and several thousands of patients. They help to determine if the new drug can be considered both safe and effective in the medium to long term. As in phase II studies patients are closely monitored but do not need to stay at the research centers.
Confirm safety and effectiveness
Compare the new drug to other compounds (e.g. a placebo or other therapies)
many thousands of patients
Phase IV research is conducted after the new drug has been approved. In these studies, the new drug is prescribed in an everyday healthcare environment. As safety is a major focus of Phase IV trials, which often involve several thousands of patients, this allows rarer side effects, if any, to be detected. In phase IV studies patients are also closely monitored but do not need to stay at the research centers.
Assess short-term safety and effectiveness
Find the dose at which the drug works best with the least side effects
Small-scale placebo comparison
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