We provide consulting services:
Computer System Validation: Whether commercial or in-house developed; desktop, client-server, or server-based; new or old; validated previously but now you've upgraded, or never before validated, we can efficiently validate your computer system to meet regulatory authority and/or your client's requirements and expectations.
CDISC Standards: With a strong background in SDTM and ADaM, we focus on the handling of pharmacokinetic data analysis and reporting. We can help you define or improve your processes and tools. We can recommend solutions to close process gaps and to streamline processes around CDISC. CDISC-based workflows and SOPs are our expertise! Ultimately, we want to help you meet the FDA requirements for submitting data in CDISC format.
Solution Development: With nearly 50 years of combined software development and script development experience (R, Python, MATLAB), we can develop your specified solution using our agile software development methodology. Our advances degrees in Statistics, Computer Science, Physics, and Engineering, and our extensive experience in the life sciences industry, make us your perfect development partners.
Quality Assurance Services: We can help you develop/implement/ refine your Quality Management System, help you prepare for a client/customer/regulatory authority audit, draft policies and SOPs, and identify and solve issues. With over 25 years of GCP/GMP experience, our experience becomes your advantage!
We provide training:
- Need an introduction to CDISC? Need to know the background and regulatory requirements for computer system validation, as well as why it is a good business practice? Need to know what a Quality Management System is?
- Whether in person or over the internet, a one-hour session or a lunch-and-learn session, or something more in-depth, we can provide training to you, your team, and your extended network.
We provide coaching:
- Have a PK scientist who is new to CDISC? Have a computer system validation person who needs some guidance on how to approach a validation project? Need a CDISC workflow SOP reviewed? Need some training materials reviewed? Need a Validation Plan reviewed?
- We can provide as much or as little as you need, to help your new personnel get up to speed, to help existing personnel expand their capabilities, to give some direction.