Study design, study execution, interpretation and report writing (related to PK and PK/PD assessment). Knowledge of evolving PK/PD regulatory requirements and climate in US, Europe and Africa.
Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
Provide expert advice and act as a reference for all medical operational activities
Write/contribute/review/QC/ validate study related documents: clinical protocols, written subject information, trial disclosure form, case report form, study plans (e.g. : study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigator meetings).
Standard and specialized PK/PD analyses, use of validated software, and reports that meet FDA requirements.
Compartmental and non-compartmental PK analyses to inform dosing selection/optimization, Identify mechanism of action, model probability of adverse effects as function of exposure and covariates.
Developmental PK/PD (pediatrics)
PK/PD in special populations (obese, renal failure etc)
Extensive expertise in bioanalytical assay development , validation and quality control based on FDA/EMA guidance.
We perform audits, pre-qualify labs, review SOPs, validation methods, summaries and reports.
More than 90% of of drugs approved within the past 5 years had pharmacometrics in their programs. We support drug pharmacometric programs including Clinical pharmacology and bioanalytical consulting. We have expertise in modelling/simulation, population and physiologically based pharmacokinetic (PK) and pharmacodynamic (PD) modelling especially in special populations (preterm, neonates, infants and children).
Work with GLP labs that can process, analyze and store specimen. They handle all facets of specimen management, including chain of custody
We accurately analyze, and interpret data from preclinical and clinical trials humans using industry-standard methods. We use streamlined approaches to data analysis and reporting of all phase studies using real-time safety monitoring and FDA reporting requirements
Please reach out to us with any concerns or special requests.
Monday -Friday: 6am - 10pm EST
Saturday - Sunday: 8am - 8pm EST
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