Phase IV clinical studies
Phase IV of the clinical trials include post-marketing surveillance and pharmacovigilance and has no determined period of time, as we are talking about continuous study of medicine already approved by regulatory institutions to be released on the general market.
The main objective of our team in Phase IV studies is to monitor the drug’s long-term effectiveness and safety in a broader, real-world population. These trials provide valuable data on rare or long-term adverse effects, interactions with other medications, and the drug’s performance across diverse patient demographics.
Why Choose 3S Pharma for Your Clinical Trial
- Our CRO offers deep expertise, personalized study design, standardized workflows and proven experience in managing Phase IV clinical trials. By overseeing these critical activities, we ensure a flawless and efficient clinical studies process.
- 3S Pharma is a Contract Research Organization (CRO) with more than 25 years of experience in the market, offering customized clinical studies design and bioanalytical services. Our long experienced team has successfully managed over 1500 clinical studies across Europe, North America, and Asia.
- Through our facilities in Romania and Moldova, with a total of 160 beds that serve the purpose of Phase I-IV clinical studies design, we are capable of accommodating study subjects from short to VERY LONG (8-12 weeks) confinement periods. The clinical units are equipped with freezers (-20, -80 Celsius degrees), cooling centrifuges, thermostatic cabinet for study medication storage, UPS, fuel power generator etc.
- Dedicated to the long term safety of our study subjects, we are also equipped with two emergency units and specialized personnel.
- Our bioanalytical laboratory is well equipped with innovative technologies in order to provide advanced techniques such as HPLC-MS/MS and ICP-MS alongside other robotic technologies, ensuring precise, accurate and reliable science based data.
- We have been inspected by various European authorities and the FDA, reflecting our adherence to international regulatory standards.
- Fast Track Approvals: Experience expedited regulatory approval in Moldavia just 2 weeks from submission
By choosing 3S Pharma, you get a CRO trustworthy partner that combines scientific expertise, state-of-the-art facilities, and a commitment to excellence and to health, ensuring the success of your Phase IV clinical trials.
More about Phase IV clinical studies
Unlike earlier phases, Phase IV trials often involve thousands of participants all over the world. They may also explore new therapeutic uses, optimal dosing strategies, and comparisons with other treatments.
Besides the clinical objectives, Phase IV studies ensure that healthcare providers and patients have the most comprehensive and complete relevant data to make informed treatment decisions.
Advantages of Phase IV clinical studies
Continuous monitoring: continuous monitoring of the drug helps identify rare or long-term side effects that may not have been identified in earlier phases.
Real-world effectiveness: using the drug in everyday clinical settings on a wide range of participants with various demographics offers relevant insights about the medicine’s real efficacy and safety.
Regulatory compliance: collected data in Phase IV of clinical studies can be used to update the medicine prescription information, ensuring that treatment guidelines are in accordance with the latest evidence. Furthermore, if safety surveillance uncovers any concerns, the drug may be removed from the market and cease to be available by prescription.
Safety surveillance: Phase IV clinical trials are considered to be one of the safest types of trials taking into consideration that the medicine has already been extensively tested and used, so one of the main focuses is on long-term safety of the population using the medicine.
