Driving the Future of Diagnostics: ACENTH to Showcase IVD Clinical Research Excellence at ADLM 2026
FOR IMMEDIATE RELEASE
ACENTH Showcases End-to-End IVD Clinical Research Solutions at ADLM 2026
Lancaster, South Carolina — July 13, 2026 — ACENTH, a specialized Contract Research Organization (CRO) focused exclusively on in vitro diagnostics (IVD) and medical device clinical research, is proud to announce its participation in ADLM 2026. The company will showcase its comprehensive clinical research capabilities designed to help diagnostic manufacturers efficiently navigate regulatory pathways from concept through commercialization.
With extensive experience supporting CLIA-waived, over-the-counter (OTC), prescription-use, and laboratory-based diagnostic devices, ACENTH provides tailored clinical development solutions for companies seeking FDA 510(k), De Novo, PMA, and other regulatory submissions.
"Our mission is to simplify and accelerate the clinical development process for diagnostic innovators," said Dr. Amrendra Kumar, Founder and CEO of ACENTH. "By combining deep regulatory expertise, experienced clinical operations, and access to high-performing research sites, we help our partners bring high-quality diagnostic technologies to market faster and more efficiently."
Comprehensive IVD Clinical Research Services
ACENTH offers a full spectrum of services, including:
- Clinical study design and protocol development
- Regulatory strategy and FDA submission support
- Site selection and study management
- Clinical monitoring and project management
- Data management and biostatistics
- Medical writing and clinical study reports
- Quality assurance and inspection readiness
- Risk management and vendor oversight
Dedicated Focus on In Vitro Diagnostics
Unlike general CROs, ACENTH focuses specifically on IVD and diagnostic device development. The company has experience supporting studies across multiple diagnostic areas, including:
- Respiratory infectious diseases
- Women's health
- Gastrointestinal diagnostics
- Urinalysis
- Cardiometabolic testing
- Rapid point-of-care testing
- Home-use and OTC diagnostics
- Digital and reader-based diagnostic platforms
Strategic Clinical Network
Through its network of experienced research sites, including MDFirst Research in South Carolina, ACENTH offers rapid study startup, diverse patient recruitment, experienced investigators, and high-quality data collection while maintaining strict compliance with FDA regulations, Good Clinical Practice (ICH-GCP), and applicable quality standards.
Meet ACENTH at ADLM 2026
ACENTH invites diagnostic developers, medical device manufacturers, biotechnology companies, and strategic partners attending ADLM 2026 to meet with the team to discuss upcoming clinical development programs and explore collaborative opportunities.
Whether developing a novel point-of-care assay, an OTC diagnostic, or a laboratory-based platform, ACENTH delivers flexible, cost-effective solutions tailored to each sponsor's regulatory and commercial goals.
About ACENTH
ACENTH is a specialized Contract Research Organization dedicated exclusively to in vitro diagnostics and medical device clinical research. The company provides end-to-end clinical development services, including regulatory consulting, project management, clinical operations, data management, biostatistics, medical writing, quality assurance, and FDA submission support. By combining scientific expertise with operational excellence, ACENTH helps innovators accelerate the development and commercialization of diagnostic technologies worldwide.
Media Contact
Dr. Amrendra Kumar
Founder & CEO, ACENTH
Email: info@acenth.com
Website: www.acenth.com