After a decade of managing regulatory inspections, we decided we deserved better tools. We developed Ready Room with the intention of using it ourselves.
As customers, we knew that Ready Room had to be quick to set up, intuitive to use, and flexible enough to handle the processes that ebb and flow as team members switch in and out of the inspection room.
We use the most up-to-date software tools and development methodologies to ensure that your data is secure, user access is tightly controlled, and information can be safely shared outside of your organization.
As consultants with budget-conscious start-ups, we knew it had to be priced for availability in the years leading up to the inspection, when critical institutional knowledge was potentially lost for lack of a central storyboarding tool.
Ready Room has transformed the way we help our customers prepare for and manage inspections. We know it can do the same for you.
Denise has over twenty years of experience in clinical quality assurance and clinical development operations. Her consulting practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharma, medical device, biotech, and CRO clients. She has held senior positions at Vertex Pharmaceuticals and Radius Health.
Pete has thirty years of computer industry and software development experience across a broad spectrum of technologies. He specializes in application design and development of multi-tiered Web applications, especially using robust application frameworks, lean design principles, and modern tooling. He previously held development, analyst, and management positions at Liberty Mutual, Burton Group, Cisco, and Netscape, as well as a number of start-up software companies.
Pam has thirty years of experience in software sales, tailoring solutions to manage risk and create efficiences for domestic and international companies. After starting her career in commercial banking, Pam pivoted to software to help improve risk management in banking’s front office. She specialized in bridging the gap between business needs and solutions, leading her to success at Moody’s Analytics, where she worked with many of the top banks in the world. She spearheaded new business development for Algorithmics and PayNet/Equifax.
A clinical program is inspection-ready when the inspection team can deliver documentation to the inspector that tells a quality story about its execution. Prepare with this practical step-by-step guide to GCP inspection readiness.