Clinical Trial Services
Helping Clients Access Special Patient Populations
ProblemFDA Letter requires a new client to perform an additional double blinded, controlled, randomized study following completion of a Phase III trial in ITP.
SolutionIn 5 weeks we were able to write a protocol, obtain IRB approved, recruit/enroll rare disease and normal subjects, test and generate a report for the FDA.
Drug approved within 6 months of the FDA letter.
Change the Unchangeable
ProblemClient is prevented from operating due to risk of staff infection by COVID-19 virus.
SolutionWithin 2 months we validated a genetic COVID-19 assay for field deployment in mobile BSL-2 lab van and received regulatory approval to enable client to protect staff with same-day, on-site testing.
99.9% of the hundreds of thousands of genetic COVID-19 swabs we've tested, have resulted on time and same-day from the start of the pandemic.
Strategic Technical and Clinical Advice
ProblemA well-funded, dominant pharmaceutical firm was in Phase II clinical trial for an orphan disease and a small, new pharmaceutical firm entered late for the same indication.
SolutionMachaon supported their trial with the fastest-in-the-industry NGS and MPLA testing to genetically confirm the diagnosis with a 2-5 day turnaround time.
A small pharmaceutical firm was able to be first to the FDA with its drug.
Trials built to Budget
Client (almost all of them) need a trial solution that was on time and within budget.
Testing cadence, budgeting tools and subject recruitment were all optimized to maximize cost saving, reduce time requirements, and minimize risks of change orders.
Over 70% of Machaon's clients return for future studies, beating the industry average of 40%.
State-of-the-art Innovation Leveraging Science and Technology
ProblemA pharmaceutical firm with a drug on the US market that treats a genetic, lethal, quickly progressive disease asked Machaon to improve the industry standard 72-day turnaround time for gene sequencing multiple complement genes.
SolutionWe studied the market and in several months, we launched a next-generation sequencing panel that improved the 72-day TAT to a 48-hour TAT.
Approximately 60% of the US clinical market uses Machaon's patented aHUS gene sequencing panels for diagnosing aHUS.
MD, Chair, Pediatric Neurosurgery
Chapel Hill, NC