Promoting excellence in clinical research
Rho is committed to integrating quality into all aspects of our organization, including every clinical trial, every service we offer, and from the very start of every clinical program.
Our goal: help customers put quality worries aside so they can focus on the life-changing work they do.
Our in-house Quality Assurance & Compliance (QA&C) team stands fully independent of our operations organization. With knowledge, guidance, a detailed Quality Management System, and the best tools of our trade, we assure adherence to optimal processes, local and international regulations, and Good Clinical Practices. We are proud of our team’s quality and compliance expertise and their passion for this vital aspect of our business.
Rho’s quality assurance and compliance system includes a Quality Board comprised of company-wide cross-functional leaders. Together, the QA&C team and the Quality Board identify business needs and the related quality risks and requirements. This approach to continuous improvement is indispensable to embedding quality by design throughout Rho. Our collaboration has a measurable impact on launching customer projects on the path to compliance from the very first steps.
Guided by Principles
Rho’s Quality Policy is fully aligned with Rho’s purpose to improve health, extend life, and enhance the quality of life through corporate and research excellence. The detailed policy outlines employees’ shared principles and goals, including:
- Understanding and taking responsibility for our customers’ quality needs.
- Creating and maintaining a sustainable quality culture.
- Embedding quality in every aspect of our business.
- Developing agile processes that support an ever-evolving regulatory environment and delivering services with the highest quality and integrity.
- Contributing to the innovation and quality by design approach in accordance with International Council for Harmonization (ICH) guidelines.
Quality Assurance Value
Rho’s focus on quality began the day we were founded and evolves as the industry evolves. New technologies, complex protocols, global expansion, and increased focus on patient wellbeing—especially when vulnerable subject participations are involved—have raised the focus on quality across our industry, especially at the start of any project. Building in quality from Day 1 through the lifecycle of the program can minimize expensive, disruptive re-work and delayed milestones.
Rho’s Quality Assurance & Compliance team can help customers identify compliance risks and, when necessary, develop a program to bring them back into full compliance. Provided exclusively by our quality professionals, our contracted services include:
- Clinical Investigator Site Audits
- Review of site internal processes for implementation and effectiveness
- Data validation and verification
- Study staff training and compliance review
- Inspection Readiness Preparedness for Clients and Sites
- Trial Master File Audits
- Clinical Study Report (CSR) Audits
- 3rd party Vendor Qualification Audits
- Software and Computer System Validation Audits
- Independent Database Audits
Our customers can be confident that their projects comply with the protocol and regulations, that they and their sites are always “inspection ready,” and that the programs minimize or avoid quality risks that affect program timing, cost, and efficiency.