The study registry module of Pristima XD Operations & Compliance allows you to write protocol and includes the required fields to create a master schedule as defined in the CFR Title 21 Part 58 GLP requirements.
Add an unlimited number of fields to automate the protocol and report writing process. Within Pristima XD Operations & Compliance, you can select specific fields during report generation and create master schedule report templates to save time and improve efficiency.
Protocol creation is easily managed through the study registry module. The cloud-based digital platform allows you to configure specific forms for creating protocols through a self-guided questionnaire process. These fields are automatically populated into a protocol document.
The protocol can then be sent through various workflow configurations for review, approval, and distribution.
Instead of re-typing content from your protocol into a report, the system automatically generates reports based on your protocol data. Use the system to generate reports for:
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.
Head of Sales: APAC | Head of Operations: India
Priya is responsible for Xybion business growth in APAC region. She brings over two decades of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.