We can help with clinical trial execution end-to-end: preclinical through phases 1-4, subject and site identification, site training, sample collection kit creation with temperature monitoring available, lab manual creation, study protocol design and execution, bioanalytical method validation, laboratory testing, LIS integration, data management, resulting to treating physician, FDA-compliant final study report, study and site monitoring, audits, study close out and archival.

We provide services to all 50 U.S. states and have served over 20 other countries including European countries, Japan, Malaysia, Singapore, Canada, Australia, Latin American countries. We have 3 sites in distinct geographical regions of the U.S. to support 510(k) studies.

We are CAP and CLIA accredited, multi-state licensed and follow GLP and GCP guidelines. We have experience with hundreds of trials and submitting paperwork to the FDA.

Machaon Diagnostics prides itself on providing industry-leading turnaround times to provide clinically actionable results. For each individual test, the website lists the routine and STAT turnaround times. In general, all biochemical and cell biological assays can be turned around within 24 hours of receipt of samples and all genetic tests within 48 hours of receipt of samples.

We put in place the needed documents: confidentiality agreement (CDA) and master services agreement (MSA). In parallel, we communicate with clients to understand the scope of their study. This is used to build a work order, which allows for us to start the study. For expedited studies, this process from CDA to work order can be completed in 1-2 weeks. Machaon Diagnostics, as a rare disease CRO, is known for being nimble and flexible.