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cro.novosolitairefoundation.com
Assessing the efficacy of therapies on larger patient populations.
Conducting post-marketing studies to monitor safety and effectiveness.
Tracking long-term patient outcomes and drug performance.
Our experienced researchers and clinicians ensure precise execution.
Equipped with cutting-edge facilities for early-phase studies.
Adhering to global guidelines like GCP and ICH for safety and compliance
Early-phase clinical trials, including Phase I studies, focus on assessing the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a new drug or therapy in humans for the first time.
We offer protocol development, First-in-Human (FIH) studies, bioavailability and bioequivalence studies, dose-escalation studies, and comprehensive safety assessments.
This phase is crucial for understanding the safety profile and optimal dosage of a drug, which are essential for progressing to later phases of clinical development.
We strictly adhere to global guidelines like Good Clinical Practice (GCP) and International Council for Harmonisation (ICH), ensuring ethical practices and regulatory compliance throughout the trial process.
Our trials are managed by a team of highly skilled researchers, clinicians, and regulatory experts, supported by advanced infrastructure and cutting-edge technology.
We implement rigorous safety monitoring protocols and maintain constant oversight to ensure participant well-being at every stage of the trial.