In the life sciences field, Document QC Teams need to possess an in-depth understanding of many different therapeutic areas, as well as extensive experience in the QC work that goes along with the documents these areas generate. Attention to detail and clear communication must be among the highest priority.
Considered by many the “Father of Modern Statistics,” Fisher laid the foundation for using different variables simultaneously in experimentation. He was the first to plan for the unexpected in testing, driven by the quest for certainty in the presence of uncertainty.
Outsourcing is quickly becoming one of the most utilized business practices in today’s challenging economy and has saved many businesses from failure by cutting costs, improving revenue and boosting operations. By outsourcing document QC, you can save time and costs by allowing your employees to continue their day-to-day activities, while document QC is completed by highly experienced, dedicated professionals in an efficient and timely manner.
Delayed CSR preparation can result in the sponsor’s loss of considerable revenue each day the marketing application approval is delayed. Mistakes can cause the regulatory reader to question the validity of the content, and may lead to errors in interpretation. A good QC review takes time, but is well worth the effort. Real lives depend on us collectively to meet deadlines and to facilitate the process of getting life-saving drugs to market.
Just about everything from ballpoint pens to lima beans have their own “days” on the calendar each year. As statisticians, we feel that it goes without saying that statistics, the system of collecting, analyzing, interpreting, presenting, and organizing data, is far more deserving of recognition than ball point pens and lima beans! We are thrilled to be celebrating National Statistics Day today, and we honor the man for which this wonderful day is commemorated.
This paper will give a preview of the soon to come non-compartmental pharmacokinetic analysis CDISC ADaM standard (ADNCA). ADNCA will be the submission data set that is sent to the PK scientist for calculation of non-compartmental PK parameters. We will present the proposed guidance and give an overview of the steps involved in developing this standard for analysis and submission to the FDA.
Pharmacokinetics, or PK, is the monitoring of the concentration level over time of an analyte within a human (or animal) body. The analyte is typically an active ingredient of a drug, or an element such as sodium or potassium, or a chemical compound which occurs naturally in blood or other body fluids, such as creatinine or bilirubin. PK data collection for an active drug compound is performed routinely in all clinical trials since it is a critical part of measuring the safety and efficacy of an experimental treatment and in determining the treatment dose amount, frequency, and time-release profile.
No matter what anybody thinks about remote workers, employers should understand the growing impact of flexible work arrangements. About 43 percent of survey takers said that they worked remotely at least sometimes, according to a recent Gallup poll.
In Part 1, we will discuss a general overview of how Pharmacokinetics and Pharmacodynamics (PK/PD) plays a key role with 3 key stakeholders: Patients, Drug Companies, and the Federal Drug Administration.
Florence Nightingale began to record data on patients, most notably, credited as being one of the first to use picture graphs and statistical analysis reports (something DataCeutics knows a bit about!).