Background
Clinical trials are a lengthy and complex process with an estimated expense between $19,000 and $26,000 per participant. Drug regimen compliance is crucial during the trial process to determine efficacy and recommended dosing strategies for specific indications. Consequently, inaccurate or missing data during clinical trials can result in a potentially effective drug being unnecessarily abandoned, or conversely, lead to the approval of a non-effective drug. Clinical trial sponsors seek ways to reduce costs of conducting trials, shorten the duration of the trial, and increase participants’ compliance and adherence to the investigational medication.
2P2D is developing ClinicAid, a wireless telemedicine system that provides real-time monitoring and documentation of participants’ drug compliance and adherence. The system dispenses drugs in personalized dosages according to the study protocol treatment regimen. It provides the clinical trial management team with real-time information such as patient compliance, accountability, and drug supply and delivery schedule.
ClinicAid’s components: drug dispenser system, data collection and distribution system, blister folding and packing system, and monitoring and accountability system.
Value Proposition
ClinicAid’s proprietary telemedicine system offers—
- improved accuracy, quality, authenticity, and speed of medical data collection in clinical trials
- real-time control of all aspects of drug distribution to patients in all settings (ambulatory and medical centers)
- ability to handle different types and numbers of medication simultaneously or separately
- full interface with patients’ electronic data diaries and Clinical Trial Management Systems (CTMS)
- ability for CROs, sponsors, and investigators to fully comply with GCP guidelines
- improved safety and quality of life for participants’
- ability to remotely and instantly halt all further drug dispensing at the patient level due to safety concerns
While there are several consumer compliance
systems that monitor patients’ medication schedules and act as a reminder, there are no comprehensive systems especially designed for the problems inherent with compliance in clinical trials.
Market
2P2D seeks to partner with CROs that offer pharma companies and hospitals a range of clinical trial management services.
Globally, an estimated 2.5 million people are participating in more than 9,300 open trials (phases II through IV) with drug intervention.
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Life Sciences/ Medical Devices
