I am trying to find software vendors who provide a complete workflow package for managing pk studies in non regulated discovery environment. Components should include:
study designer
study scheduler (scheduling multiple legs of a study on different days and a common calendar)
Dose calculator
collecting in life data and observations
identifying samples in 96 well collection plate
enabling processing of samples on liquid handler for LCMS analysis
collecting and reporting concentration data from LCMS
Importing concentration data into pk software like winnonlin
Is a software used by more than 5,000 researchers and 2,000 institutions world-wide, including multiple global regulatory agencies, Phoenix® WinNonlin® is a complete solution with data management, statistical, modeling and graphics tools. With it, researchers can perform:
1-Non-Compartmental Analysis (NCA)
2-Individual compartmental PK/PD modeling and simulation
3-Other types of analysis including bioequivalence
Functionality
Data import and preparation
-Import data from Excel and ASCII files. Phoenix WinNonlin 6.4 allows users to create smaller project file sizes and use less memory by importing only selected worksheets and columns from raw data files.
Organize data with tools that can filter, join, merge, pivot, rank, split, and stack data
PK/PD Analysis
-Analyze multiple matrices (plasma or urine), dosing schedules, and dosing routes using NCA
-Perform compartmental modeling using built-in models or self- generated ones, either graphically or using the Phoenix Modeling Language (PML)
-Evaluate the bioequivalence of averages, individuals, or populations
Graphics capabilities and report generation
Generate report-ready graphs, tables, and figures with full user formatting control
Insert bar, column, and box plots; histograms; XY, lattice, XYY plots, QQ plots, and/or scatter plot matrices easily into workflows
Export worksheets and figures to Microsoft® Excel® or Word®, SAS®, graphic files, or text with one click
I agree that Phoenix WinNonlin is a great package, (I am the lead trainer for this software in EU!), for the PK elements of your question however regarding the LIMS functionalites I personally have had very good experience with Watson since it is designed from the beginning to support bioanalysis in the pharma industry.
As a leading LIMS with which many of out users interact we have recently enhanced our direct import functions so that users with Connect license can pull directly from Watson and also apply business rules to the imported data. If you want to find out more about this function please look at our user forum;
Naguibou and Simon - Thanks for the responses. We are currently using Phoenix WinNonLin for clinical studies but my need is in the discovery space. I have seen Phoenix WinNonLin, Connect, and PKS in action and it only covers item 8 and 9 on my original list.
I am looking for a system that allows us to design discovery small/large animal studies, assign resources (people, room, equipment) to the study, Schedule the In Life portion on a shared calendar, Collect in life observations, create 96 well plate map and sample list, consumes the sample list to create analytical run (Watson Capability). In addition, it needs to manage approval workflow that with ability to transition studies to different phases of its workflow.
The discovery groups run through 3500 studies per year and time/ease of use is of critical. While PKS/WinNonLin/Watson can do most of these, they are not flexible enough to handle on the fly changes needed in discovery.
from my experience I thought discovery groups found they could get pretty close with Watson (or Galileo, does Thermo still sell that?)- have you asked on the linkedingroups for LIMS and Watson - maybe they have some tips ?