CLINICAL TRIAL SOLUTIONS
Get support from an experienced quality assurance team
Through our clinical quality assurance (QA) services, PharPoint helps sponsors strengthen oversight, align teams, and build the proactive quality culture that modern regulators expect. We provide practical tools, tailored guidance, and thorough auditing support to ensure clinical trials operate with participant safety and data integrity in mind.
PharPoint combines extensive knowledge of GxP, ICH standards, and FDA regulations with proven quality-improvement methods to drive risk-based thinking, operational efficiency, and sustainable quality culture.
How can PharPoint’s QA team help?
QA Consulting
Our quality consultants have deep expertise within GxP and can help sponsors assess current workflows, identify risk areas, and guide teams through practical improvements.
Auditing
PharPoint has a long history of supporting sponsors through audits. Our auditors are highly experienced and deeply familiar with GCP, FDA regulations, and ICH guidelines.
ICH E6(R3) Compliance
Is your team prepared for ICH E6(R3)? Work with a consultant to assess your current status and build practical, organization-wide changes that support a shift toward proactive, risk-based quality.
Is your team inspection-ready?
PharPoint’s QA specialists partner with sponsors to strengthen inspection preparedness at every level. This can include:
- Assessing and mitigating regulatory risks before they become findings
- Outlining and supporting remediation activities with clear, actionable guidance
- Facilitating cross-functional team trainings
- Hosting mock inspections to surface gaps and build confidence
Everyone talks about “quality culture.” But can you be certain your team and vendors have it? Discover the practical indicators that separate the buzz from the real thing.
→ Read: Evaluating Quality Culture in Clinical Research: Beyond the Buzzword
Related Resources
Explore resources and perspectives from our clinical QA team
Evaluating Quality Culture in Clinical Research
Evaluating Quality Culture in Clinical Research: Beyond the Buzzword While it’s one thing to discuss a culture of quality in clinical research, it’s much more complicated to make it a reality – embedded into the way teams think, act, and make decisions across an entire organization. This echoes timeless guidance from
Why Deming’s Out of the Crisis Still Shapes My Approach to Clinical Quality
QA Director Melisa Williamson talks about "Out of the Crisis" by W. Edwards Deming and how it has influenced her approach to quality.
Meet Melisa Williamson, Director of Quality Assurance
Get to know PharPoint's new Director of Quality Assurance, Melisa Williamson, with a quick Q&A.