The PDS team is comprised of more than programmers — we have scientists and IT specialists, which means we do more than software. We offer a variety of consulting services, both as a complement to our software and as stand-alone solutions to help you manage and analyze your data better.
SEND Guidance and Implementation
In addition to TranSEND™, your complete submission management solution, we also provide guidance on SEND requirements, as well as methodologies to create SEND files and support to compile Reviewer Guides. The PDS team consists of active members of PhUSE and other relevant standards implementation groups — we maintain awareness of the latest information. Our experts will educate your team on the SEND process, helping to give them an understanding of their LIMS outputs and whether they meet SEND requirements. We’ll also help familiarize your team with the FDA portal for trial SEND submissions.
System and Equipment Validation
PDS offers comprehensive assistance in performing and documenting validations of systems and equipment, including drafting and review of documents, determining what to validate and understanding requirements. Our team has developed automated validation tools that can help reduce your software validation to weeks instead of months or even years.
General Toxicology Studies
Our team can provide general advice on toxicology studies and logistics, with recommendations to make work practices efficient, e.g., recording data, reporting data, performing procedures, etc. PDS can also help you refine dosing and bleeding techniques, study setup and design, logistics, and more.
We offer guidance on the logistics and conduct of infusion studies, e.g., documentation, setup, use of infusion equipment, etc.
Data Collection Systems
Our experts can advise you on best practices for data collection and also identify ways to improve workflow and documentation via either work practices or data collection methodology.
Developmental and Reproductive Toxicology (DART) Processes
We provide assistance with all DART processes from protocol drafting, to review of data and most processes in between, especially C-section and necropsy endpoints. PDS also provides technical assistance training in C-sections and fetal evaluations. This can include protocols, processes and SOPs. PDS experts also provide general advice on collection and recording of fertility and teratology studies.
Toxicology Laboratory Operations
PDS offers general consultation in toxicology laboratory operations, including resource scheduling, study scheduling, operational process improvement, etc.
Other Consulting Services
- Data integrity: Design processes to best ensure high integrity data
- IT infrastructure: Server architecture for PDS products now and in the future
- Software development life cycle (SDLC)
- Staffing models for technology (insourcing/outsourcing/near/far)