Our additional services fall into three major areas: training, validation and consulting.
Beyond the basic introductory training that takes place so that you are comfortable with using PDS software, we have also developed focused and customizable training programs. These programs are centered on areas that have been identified to help drive even more efficiency into their workflow. The benefits of these types of training sessions are both immediate and enduring. Additionally, most of the classes offered can be provided at a GLP level, which means a certification of attendance that is appropriate for inclusion in the attendee’s training folder is available.
- Pathology software training for study directors, technicians, IT, QAU and administrators
- Data assurance/report generating team training
- Toxicology software training for study directors, technicians, IT and QAU
- Reprotoxicology software training for study directors, technicians, IT and QAU
- Clinical pathology training for supervisors, technicians, IT and QAU
- Database training for toxicology, clinical pathology, reproductive toxicology and pathology
- DrugBase training: Administration of compounds and formulation of compounds and linking to studies
- Reporting training on a per-module basis
- Creation of templates for study types on a per-site basis
- Necropsy training for technicians
- QAU-specific training for electronic log files and audit trails
- New hire system training customized to job description
Most PDS users conduct GLP studies, and the scope of the validation required depends on the manner in which they have licensed PDS software. PDS will assist with any validation steps during your installation process.
For customers that have traditional licenses and are running the software from within their own IT infrastructure using their own servers, a complete initial validation is necessary and includes installation qualification, operational qualification and performance qualification.
For customers utilizing our hosting center for subscription or hybrid access to PDS software, installation qualification and operational qualification are covered as part of our qualification process as GLP, while a performance qualification will still be required.
As one of the world’s leaders in the design, development and deployment of preclinical software, we truly understand how our software plays a critical part in the advancement of your science. Therefore, we offer customized and focused consulting services in a broad range of areas to help advance your research even further. Below are some examples of the areas in which we can assist you. Read more about our consulting services >
- Project planning
- Product training for the IT team that includes GLP considerations
- Development of additional interfaces to integrate existing software and/or devices at your request
- Device training: Balances, chip readers, Hamilton pumps, clinical pathology instruments, etc.
- CSS: Training on how to modify cascading style sheets
- Creation of templates for study types per site
- Support staff availability on site at first necropsy or toxicology study initiation
- PDS webinars on release notes for new software releases and other topics of interest customized to your needs
- Training documents on a per module or package basis
- Toxicology and pathology report authorship and review
- Preclinical toxicology and pathology consulting for large and small molecules
- Reproductive toxicology: Skills experts, skeletal, visceral, startup reprotoxicology lab
- SENDv3 pilot for FDA submissions (More on our SEND services)
- Creation of SENDv3 files for legacy data
- Data conversion into SEND-ready format for FDA submission
- SEND terminology mapping
- Glossary migration
- Study migration