- Protocol implementation and maintenance (development of standard physician orders; building computerized laboratory tests; refining sampling and processing procedures.)
- Set-up of Cerner mnemonics and instructions
- Set-up of laboratory procedures and tracking mechanisms
- Communication with sponsors and investigators
- Refinement of Pharmacokinetic sampling schedules
- Pharmacokinetics nursing assistance
- In-servicing of clinical departments
- Implementation of standard orders.
- Research sample acquisition (centralized receiving, initial processing, storage, and distribution of clinical samples.)
- Computerized tracking and labeling systems for acquisition, tracking, and sendouts initial centrifugation
- Preparation of tissue fractions, ultrafiltrates and cell lysates
- Long- and short-term storage
- Distribution to other investigators within St. Jude and outside of St. Jude.
- Assay implementation & ongoing quality control/ biomedical modeling.
Biomedical modeling of pharmacologic data has two main aspects - clinical and preclinical.
Clinical modeling includes three main phases:
- Model Design - The model design phase involves determining the most appropriate pharmacokinetic/pharmacodynamic model which adequately describes the data, considering historical, and preliminary clinical.
- Sampling Strategies - The sampling strategies phase involves determining the most appropriate sampling times (using D-optimality methods): those that provide the most pharmacokinetic/pharmacodynamic information with the least inconvenience to the patients and staff.
- Data Analysis - The data analysis phase involves determining and using the most appropriate nonlinear curve fitting techniques to best describe the data. These include maximum likelihood estimation, maximum a posteriori probability (MAP) estimation for individual results, and linear and nonlinear mixed effects modeling methods for population results.
Preclinical modeling involves many of the clinical aspects along with developing appropriate sampling strategies and parameter estimation methods appropriate to sampling.