The cost of introducing the drug exceeds USD 2.3 billion. Despite this, investments worth billions depend on subjective declarations made by study participants. 

Cost of Error: On average, 30% of participants in a DCT study do not take the drug according to the protocol.

• This necessitates costly over-recruitment.

• It generates an avalanche of queries that paralyse DB Lock

• It makes it impossible to assess causality in Adverse Events.

MITERION™ provides biochemical proof of drug intake by verifying physiology rather than declarations.

• The participant activates the packaging [opening registration].

• The participant swallows the drug with the marker.

• A short exhalation into the Docking Station confirms the presence of the marker.

• The result is immediately sent to the eCRF system [eSource].

For the Sponsor and CRO, Miterion is a ‘Plug & Play’ tool for cost optimisation:

• Less monitoring: Automated verification of medication intake eliminates the need for manual SDV.

• Faster DB Lock: Data is complete, accurate and time-stamped. Eliminating audit risk allows for faster study closure.

• Confidence in safety: Hard evidence of dose intake at the time of adverse events (AE/SAE) allows for rapid causality assessment and elimination of false alarms.

• Zero-MDR: The system functions as a ‘Research Tool,’ ensuring rapid implementation without medical certification at launch.

• Functional PoC of the docking station – TRL 5.

• Scientifically confirmed physicochemistry of detection – TRL 3.

• Provisional Patent Application [Patent Pending]

• The goal is to acquire a strategic partner/funding for the finalisation of engineering work and pilot implementation.

MITERION™ becomes a strategic acquisition target for CRO giants [IQVIA, Labcorp] as the missing link in their Decentralised Clinical Trials offering.