Phase II in clinical studies
Advancing Drug Development with 3S Pharma
Phase II of clinical trials is part of the Early stage in clinical studies and is focused mainly on the therapeutic efficacy and safety of the drug, but it is also the initial stage in which we start to collect data. This phase may last from several months, up to two years.
Phase II is conducted on hundreds of participants, healthy subjects, but mostly patients who have the disease or condition that it is being developed to treat, at the safe dosage found to be in the first phase of the clinical study. So, treatment and dose response studies may therefore be carried out and confirmed in the Phase II trial.
These trials often include randomized and controlled methodologies to compare the new treatment against a placebo or standard therapy.
The results from this phase, the effectiveness and safety of a new medicine, are very important for the product to advance into Phase III. This is the stage of the clinical trial in which scientists start refining the methodology for standards and optimum design for the larger third Phase study.
Phase II of clinical trials also gather relevant data concerning any adverse effects that may have been underseen in previous stages, but also their interaction with other medication.
Phase II of clinical studies has, usually, two stages, Phase 2a and Phase 2b. At 3S Pharma, we are proficient in Phase 2a studies focused on dosing requirements, with excellent outcomes.
The data collected in Phase II trials are crucial for designing larger Phase III trials and for making decisions about the drug’s future development.
Advantages of Phase II in clinical studies:
- Efficacy Assessment: we can establish if the treatment is effective for the targeted condition through the clinical trial participants.
- Safety Monitoring: we assess the treatment’s safety characteristics in a larger group of participants, healthy people and people diagnosed with the disease.
- Dosage Determination: we can establish the optimal, efficient and safe dose.
- Informed Decision-Making: we can provide relevant essential data for regulatory bodies and partners to decide on progressing to Phase III clinical studies.
Why Choose 3S Pharma for Your Clinical Trial
3S Pharma is a company moving beyond traditional Contract Research Organization (CRO) services, offering comprehensive clinical development and bio-analytical services through a comprehensive and unique clinical study design.
Our team has an unitary vision that is based upon deep understanding of the process in order to conduct and implement complex clinical trials, looking beyond the surface and personalizing every step and decision made through the journey.
At 3 S Pharma we are problem solvers and we value true and long lasting partnerships. We couldn’t set this goal if we couldn’t deliver high standards processes and transform problems into opportunities.
- With dedicated clinical research units in Romania and Moldova, we conduct Phase I-IV trials across Eastern Europe.
- Our specialized team of over 100 professionals, including medical doctors, pharmacists, and biologists, ensures high-quality execution of clinical studies.
- We are proficient in delivering authentic and personalized study design, which can be, most of the times, more efficient than the standard existing designs.
- With a strong presence in both EU and non-EU countries, we offer efficient patient recruitment and compliance with regulatory expectations, making us a reliable Phase II clinical trials partner.
We have strong regulatory compliance, an asset that allows our company to ensure that the clinical trials we conduct have ethical standards while yielding high-quality data.
By choosing 3S Pharma, you choose a CRO partner with over 25 years of tradition in delivering excellence in clinical studies worldwide, a partner that combines scientific expertise, state-of-the-art facilities, ensuring the success of your Phase II clinical trials.
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