Secure, Connected, Monitored
Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Clinical trials may be conducted directly by the Pharmaceutical company or contracted out to specialized research organizations. A contract research organization (CRO) is such an organization and provides direct support to the pharmaceutical, biotechnology, and medical device industries in the form of outsourced research services.
The challenges facing a pharma company or CRO in running a clinical trial such as consistency, accuracy, persistence, data capture, anonymity, and security, it’s good to know that help is on the way.
Benefits for Clinical Trials
RxPense® has been designed from the ground up as a secure, connected, medication dispensing and management system, simple enough for seniors with mild cognitive impairments and chronic disease sufferers to use. RxPense® keeps the medications secure and locked up until needed, controls the release of medications to the patient/study participant, records the consumption and health data provided by external sensors or patient interaction with the touch screen.
Regardless of ethnicity, race, language or location, RxPense® can be deployed anywhere to better manage your clinical trials.
With up to 66% of the costs for Clinical Trials Research going to Data Collection and Monitoring, it’s easy to see how an automated, secure, medication dispensing and remote monitoring hub, like RxPense, can save Sponsors and CROs a lot of money.
Supporting All Four Phases of Clinical Trials
Phase I studies assess the safety of a drug or device. This initial phase of testing, is primarily designed to determine the effects of the drug on humans and also investigates the side effects that occur as dosage levels are increased. RxPense® can assist with this phase by controlling the dose and monitoring vitals, reporting anomalies as soon as they occur.
Phase II studies test the efficacy of a drug or device. This second phase of testing can up to two years and are randomized trials where one group of patients receives the experimental drug, while a second “control” group receives a standard treatment or placebo. RxPense® can assist with this phase by controlling the release of the real or placebo medications and monitoring vitals, reporting anomalies as soon as they occur.
Phase III studies are usually large-scale tests involving randomized and blind tests which can last several years in order to provide the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device. Following a successful Phase III, the company can request FDA approval for marketing the drug. RxPense® can assist with this phase by controlling the release of the dose, amount and frequency, monitoring patient vitals and reporting anomalies as soon as they occur.
The final phase of a clinical trial, Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. RxPense® can help pharmaceutical companies (1) to compare a drug with other drugs already in the market; (2) to monitor a drug’s long-term effectiveness and impact on a patient’s quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Since RxPense® can accommodate all drugs, patient anonymized (Big) data can be collected and provided to the industry in support of Phase IV.
Return On Investment
Justification for the inclusion of new technology is not simply a matter of lease verses buy. It must first present a real business case and answer some pointed questions like: Can the technology reduce program cost? Can it reduce risk? Will the product or service increase reliability and accuracy of data?
In the case of RxPense® we have prepared a sample ROI sheet, in our whitepaper, for a 24-month clinical study of a new oncology (or other) drug. We highlight some of the typical cost drivers and how they impact the study, with and without the inclusion of an RxPense® Medication Management solution. The actual cost will vary market by market and county by country.
Clinical Trials FAQ
Q: How can you improve trials with your device?
There are many ways in which an RxPense® can improve clinical trials. As an example, we help reduce common errors of over/under dose, forgetfulness and timing by ensuring the patient is notified, securely identified, and takes the correct medications, in the correct amounts, at the right time. When they do not, an alert is raised and recorded. The device is interactive and records a complete audit trail, with patient images, dose and dispensing information each time the patient touches the screen to release or confirm consumption. All data is securely stored in the Cloud, abiding with PIPEDA in Canada and HIPAA in the USA.
Q: The RxPense® is multilingual and offers multiple levels of security and user access.
Through our Bluetooth interface, we are able to connect with other sensors, collect vitals, store and transmit this data in the cloud. The patient profile will have a consolidated view of the patient’s medication and health history. Alerts can be raised when pre-establish levels are exceeded (Blood Pressure, Temp, SpO2, Heart rate…). We can even connect to other devices that are already connected to another Cloud and pull in that data to a provide concise, consolidated view of the whole patient profile.
Q: What kind of data can you supply to the pharma during a trial that they can’t have today?
Today, Pharma can usually obtain any information they want, but this may be extremely difficult or too costly. Without the cost of an onsite nurse, RxPense® can more easily and objectively, dispense medications, monitor health and record all events for remote access, by pharma.
RxPense® operates in real-time, with built-in 3G/LTE, WiFi or Ethernet connectivity to the Cloud. Pharma can monitor the dispensing, consumption, regularity, timing and correlated health data in real-time, across all connected devices, worldwide. Imagine a patient with a Hexoskin wearable, with all data collected and correlated with the medication data and uploaded real-time. An amazing true picture of the condition of the patient during a trial.
Depending on the phase of the trial, we can stop, start or skip consumption of doses during a trial, remotely. We can prevent abuse and theft of medications by family members and others. We can present and record surveys and data collection, video, voice and data 24×7. We can ensure a strict regimen is followed by the patient during trials and immediately report abnormal events. We can also secure the trial data permitting only those authorized persons to access.
Since all data is collected and reported in real-time, pharma can start data analysis/big data mining at anytime.
Q: Is your Portal 21 CFR Part 11 Compliant?
The software development methodology and quality system that is in place at Medipense along with the functionalities of the cloud-based software have been independantly reviewed for ability to comply with FDA 21 CFR part 11. The conclusion is that the software is part 11 ready and if configured properly by the client will meet 21 CFR part 11 expectations for compliance.
If you would like to explore RxPense® and how it can help with your next Clinical Trial, please: