Insights for FDA Regulated and HIPAA Compliant Organizations
11 Steps on the Path to Fulfillment for Diagnostic Testing Organizations
The genomic and diagnostic testing sector is playing a critical role in shifting the healthcare and drug discovery landscape. Rising healthcare costs and consumer demand have created a need for advanced tools that are fast, accurate, informative, affordable, and less invasive for clinical decision making.
Ongoing significant technological and scientific advances, and changes within global healthcare systems are leading the world into a diagnostic revolution. The promise of precision medicine and treatments is closer than ever before.
Today, more than ever, there is an increase of consumer awareness, acceptance, and understanding of the incredible importance and value of diagnostic testing.
Companies are finding that by outsourcing their test kitting and distribution programs to dedicated industry experts, they can achieve fast and effective market reach on a global scale.
True fulfillment requires finding a provider with these 11 capabilities:
- Full sourcing and procurement of all medical components in a kit
- In-house production of kit boxes, instruction sheets, bar-coded labels
- In-house design and engineering teams for both internal and external kit construction and graphics
- World-class warehousing and inventory control systems with real time access
- Seamless IT / API ordering mechanisms with reverse feeds for package tracking
- Kit assembly in ISO 13485 certified facilities including date and lot control of all components
- Redundant operational and quality systems in each facility to ensure a seamless customer experience
- Vast experience in temperature control, chain of custody, and temperature integrity of specimen samples during transport
- Customization and personalization of kits to individual patients including TRF's
- Relationships with all major shipping carriers with significant discounts anywhere in the world
- An electronic invoice process (Paperless Trade); and a global standard customs clearance process for your program providing no more paperwork for clinics
Genomic and diagnostic testing organizations are in need of answers of how to reach their patients and customers world-wide with products that can positively impact lives and improve outcomes. With the help of the right partners, those answers are available now.