Phase III clinical studies
Phase III clinical studies are pivotal in the new medicine design process and can, in various cases, be the last stage upon drug approval. In this phase of clinical trials, a large-scale study with hundreds to thousands of participants, the scope is to confirm the efficacy and monitor the safety of a new treatment across diverse targeted subjects.
Why choose 3S Pharma for your clinical studies
- 3S Pharma is a Contract Research Organization (CRO) with more than 25 years of experience, offering comprehensive clinical development and bio-analytical services worldwide
- Our quality work is proven by over 100 audits conducted by customers and third parties, all with positive conclusions and stating GCP compliance, and 18 GCP inspections in The Netherlands (1) and Romania (6). Out of the 18 inspections, 10 were performed in Romania and 8 in Moldavia (last inspection was performed recently by EMA in June 2024). All inspections concluded with GCP compliance and data acceptance.
- From Protocol and CRF development to final report, at 3S Pharma we can deliver the complete package of services with full customized studies design.
- We can conduct simultaneous large clinical trials through our facilities that include a privately owned clinical research facility in Romania with a 74-bed capacity and a bio-analytical laboratory equipped for advanced analyses. Also, in Moldova, we operate BE units in collaboration with public hospitals from Chișinău, providing an additional 86 beds.
- In case of studies requiring a large specific group of patients, we have several contacts with other hospitals from Armenia, Bosnia, Georgia and we keep on developing new collaborations.
- Our team comprises over 50 professionals, including medical doctors, pharmacists, and biologists, ensuring high-quality execution of clinical studies.
- With a strong presence in both EU and non-EU countries, we offer efficient patient recruitment and regulatory compliance, making us a reliable partner for your clinical trial needs.
Not sure what CRO partner to start your Phase III clinical study? Our specialists are here for you.
More about Phase 3 clinical studies
In Phase III of clinical studies, the specialists compare the new experimental treatment to existing standard therapies or placebos to determine its relative effectiveness, the safety level, and potential side effects that are not seen in the early phases, which are vital for regulatory approval and may also study how well a new treatment works over a long period of time.
Advantages of Phase III clinical studies for companies
- Comprehensive care: regular monitoring and assessments ensure close oversight of participants’ health.
- Contribution to medical research: advancing medical knowledge and improving future treatments.
- These trials are essential for determining a treatment’s effectiveness and safety in a broader patient population, ultimately leading to better healthcare outcomes.
An important aspect is that the extensive data collected in Phase III helps identify less common side effects and ensures the treatment’s benefits outweigh any risks, without adding significant harm.
In Phase III, a key aspect in the studies is the inclusion of a control group that receives either a placebo or the standard treatment. That is why, through a customized design engaging a significant number of participants, Phase III trials provide a more accurate representation of the drug’s effectiveness.
Other important aspects in the design of a Phase III study are randomization and blinding, methods that help eliminate any potential bias influencing the clinical study’s results.
Also, in Phase III of clinical trials, we can test new drugs, already approved medicine, or other forms of treatments. The scope of clinical studies, in the end, is to provide the real environment for researchers to learn if a new drug, treatment, or combination works and is safe to use for specific people.
Other factors that may be considered in Phase III of clinical trials include improvement in patients’ quality of life and secondary benefits of the drug.
This Phase of clinical studies takes longer than Phase I and Phase II, usually over 2-4 years, with multiple study sites and a diverse patient population, and it is, commonly, thE last stage for the approval of a new drug for market usage.
