Innovative Trial Solutions
Clinical Trial Services
Helping Clients Access Special Patient Populations
Problem #1
Problem
FDA Letter requires a new client to perform an additional double blinded, controlled, randomized study following completion of a Phase III trial in ITP.Solution
In 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.Outcome
Drug approved within 6 months of the FDA letter.
Change the Unchangeable
Problem #2
Problem
Client is prevented from operating due to risk of staff infection by COVID-19 virus.Solution
Within 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.Outcome
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
Problem #3
Problem
A 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.Solution
Machaon 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.Outcome
A small pharmaceutical firm was able to be first to the FDA with its drug.
Trials built to Budget
Problem #4
Problem
Client (almost all of them) need a trial solution that was on time and within budget.
Solution
Testing cadence, budgeting tools and subject recruitment were all optimized to maximize cost saving, reduce time requirements, and minimize risks of change orders.
Outcome
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
Problem #5
Problem
A 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.Solution
We 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.Outcome
Approximately 60% of the US clinical market uses Machaon's patented aHUS gene sequencing panels for diagnosing aHUS.
Delivering results when they matter most.
“We are VERY happy; Great job in getting out the ADAMTS13 level & inhibitor screen! We are VERY happy – great quality results and turnaround time. Love the interpretive comments. Thanks – good job!”
MD, Chair, Pediatric Neurosurgery
Chapel Hill, NC
Challenge Us.
Click here to see examples of our Innovative Trial Solutions that we have created for clients.
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