Kresnier Perez

Celerion is a prominent name in the realm of clinical research, recognized for its commitment to advancing medical science through rigorous and innovative studies. Founded in 1979, the organization has established itself as a leader in early clinical research, providing essential services that support the development of new therapeutics. With a focus on pharmacokinetics, pharmacodynamics, […]

Investigational Device Exemptions (IDE) clinical trials represent a critical phase in the development of medical devices, allowing for the evaluation of new technologies that may not yet have received full regulatory approval. The IDE process is governed by the U.S. Food and Drug Administration (FDA) and is designed to ensure that new devices are safe

Clinical trials are structured research studies conducted to evaluate the safety and efficacy of new medical interventions, including drugs, devices, and treatment protocols. These trials are essential for advancing medical knowledge and improving patient care. They typically follow a rigorous protocol that outlines the study’s objectives, design, methodology, and statistical analysis plan. Clinical trials are

Clinical trials are structured research studies conducted to evaluate the safety and efficacy of new medical interventions, including drugs, devices, and treatment protocols. These trials are essential for advancing medical knowledge and improving patient care. They typically involve human participants and are designed to answer specific questions about how a treatment works, its potential side

Risk management in clinical trials is a critical component of the drug development process, serving as a systematic approach to identifying, assessing, and mitigating potential risks that could jeopardize the integrity of the trial or the safety of participants. The complexity of clinical trials, which often involve multiple stakeholders, diverse patient populations, and intricate regulatory

Clinical trials are structured research studies designed to evaluate the safety and efficacy of new medical interventions, including drugs, devices, and treatment protocols. These trials are essential for advancing medical knowledge and improving patient care. They typically follow a rigorous protocol that outlines the study’s objectives, methodology, and statistical analysis plan. The phases of clinical

Phase 1 studies represent a critical juncture in the drug development process, serving as the initial step in evaluating the safety and pharmacokinetics of new therapeutic agents. These studies are primarily conducted in healthy volunteers, although certain conditions may necessitate the inclusion of patients with specific diseases. The primary goal of a Phase 1 study