The story behind CENTOGENE's 90% reduction in Audit burden

About CENTOGENE 

CENTOGENE is a global biomarker laboratory providing specialized testing services for the pharmaceutical industry. 

The Challenge 

As a clinical service provider managing complex diagnostic testing and biomarker analysis, CENTOGENE faced a common challenge across growing providers: scaling up meant an exponentially higher audit volume, which placed an immense burden on their team. 

Every pharma client required an on-site qualification audit before CENTOGENE could begin work. With approximately 20 audits per year at $35,000 each, CENTOGENE faced a $700,000 annual audit burden that created significant operational strain.  

Each on-site qualification required shutting down laboratory operations, pulling senior executives from critical work, coordinating multi-location employee travel, and multi-day preparation. As their client base grew, the audit calendar became a bottleneck—new clients waited months for available slots, delaying partnerships and revenue. 

CENTOGENE needed a way to eliminate this redundant burden while maintaining the rigorous qualification standards pharma clients require. 

The Solution 

CENTOGENE partnered with Diligent Pharma to transform their qualification model. Instead of hosting 20+ individual client audits per year, CENTOGENE now hosts a single comprehensive on-site audit conducted by Diligent Pharma. 

• Single Qualification, Multiple Clients: Diligent's audit report is released to every pharma client needing to qualify CENTOGENE, eliminating redundant on-site audits while maintaining rigorous standards. 

• Accelerated Onboarding: Pharma clients receive detailed qualification packages in days rather than waiting months for audit slots. 

The Results 

In approximately 18 months, CENTOGENE achieved: 

• 85% reduction in audit burden, eliminating 17 on-site qualification audits 

• $595,000 in cost savings, reinvested in laboratory capabilities and growth 

• Faster client onboarding, with qualification packages delivered in days instead of months 

• Scalable growth model where expanding the client base no longer requires proportional increases in audit management resources