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Recognizing the complexity of modern trials, we navigate challenges and ensure seamless, accurate outcomes.
The drug development continuum involves scientific innovation and rigorous validation, starting with drug discovery to identify novel molecules or biologics for disease treatment, and progressing to the preclinical stage once a promising candidate emerges.
Preclinical studies in new drug development are crucial. Conducted in laboratories and using animal models, these studies are designed to:
Once a compound successfully clears preclinical studies, it enters clinical drug development, a highly structured series of phases involving human participants:
This initial phase of clinical drug development involves a small group of healthy volunteers or patients. The primary goal is to assess the drug’s safety, determine a safe dosage range, and study how the drug is absorbed, metabolized, and excreted by the body (pharmacokinetics).
In Phase II, the drug is administered to a larger group of patients who have the disease or condition the drug is intended to treat. The core attention changes to assessing the drug’s conclusiveness, further evaluating safety, and ascertaining the optimal dosage and treatment plan.
Phase III trials are large-scale, often multi-center studies involving hundreds to thousands of patients. It confirm drug efficacy, monitor adverse reactions, and compare it to existing treatments or a placebo, requiring regulatory approval for successful completion.
Even after a drug is approved and marketed, clinical drug development continues with Phase IV studies. These involve ongoing surveillance to monitor the drug’s long-term safety and effectiveness in diverse populations, and to identify any rare or long-term side effects.
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Streamline Your Drug Development with Curexbio CRO Expertise
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