Medication nonadherence is highly problematic in pharmaceutical studies. Without direct observation of pill-taking patterns, clinical investigators are often misled by reported adherence and may falsely interpret a protocol’s true efficacy.

is an integrated system that tracks real-time intake of medications and provides passively monitored data captured in naturalistic settings. It offers a unique and optimum toolset for pharmaceutical researchers to:

• Improve data collection reliability and ease. Reduce attrition. Identify and remedy non-performing participants early.  Export data anytime.
• Conduct polydrug efficiently. Tracks 1-4 drugs simultaneously (1-12 drugs after January 2008)
• Converts quickly from regimen delivery to a control condition data collector
• Remotely monitor home-based biosensors (January 2008).
• Cut  costs, labor, and participant burden.
• Set  devices remotely.  Two-way communications lets you change settings when prescriptions change, without an office visit.
• Reuse devices with new participants, new studies.
• Accelerate time to market for a new drug. Continuous data collection enables adaptive trials and overnight data analysis.
• Optionally, execute customized study treatments with reminder signals.
• Match device models and functions to your study protocols. Choose frequency of uploads to match your needs and budget.

The Problem:  Pill counts fail to reveal timing of intake, lost or hoarded medications, “white coat compliance” (compensating for missed doses by dumping or over-dosing just before appointments).  Self-reported adherence is notoriously flawed.  Re-orders and claims data provide even less reliable information.

The Solution: With MedSignals, every lid opening is time-stamped and recorded in memory – accurately, indelibly, and real-time

• Usage data are uploaded automatically to a host server (on immediate, daily or weekly basis.)
• Investigators can observe protocol adherence and export data remotely 24x7
• Comma delimited time-stamped event data easily exported to your spreadsheets
• Reduced "white coat compliance"

MedSignals puts an end to guesswork.

• No more recall questionnaires and self-reported summary data
• No more paper diaries and autobiographical and recall bias
• No more exaggerations to please coordinators

The Problem: Some studies involve multi-drugs or co-morbid conditions.  Observing only one pill in a polydrug study – to save costs – may not accurately represent intake of all drugs.

The Solution:  MedSignals allows several drugs to be monitored simultaneously – all for the price of one drug.

• Monitor daily doses of up to 4 medications
• Reminder signals can be turned on or off, for treatment or control conditions
• Data uploads through participant’s phone line as often as you wish
• Remotely monitor progress on participants’ charts or on aggregate dashboards of all participants.
• Exports comma delimited values anytime, 24x7, to your spreadsheets

The Problem: Conducting a clinical trial in a traditional manner is costly, time-consuming, and only marginally representative of real-world use of a drug.

The Solution: MedSignals allows a clinical trial to reduce costs and labor intensity, as well as participant burden

Cut Costs and Labor Intensity

• Uploaded data collection from the field decreases office visits
• Less equipment to purchase (1 device : 4 drugs)
• Quickly identify and manage non-performing participants
• Copyright technical text furnished for grant applications

Ease Participant Burden

• Fewer office visits
• No need to bring meds to office visits for pill counts
• No diary keeping
• Less autobiographical bias and recall loss
• Less guilt and "evidence tampering" associated with poor compliance

UPLOAD COSTS:
3 optional frequencies to fit your budget and priorities:	Cost/Month
Daily uploads from a participant’s home	$15 / month
Weekly uploads (up to 5 uploads per month) pre-paid on 12-month basis	$3.50/ month
Immediate uploads (when new data are generated)	$75 / month

The Problem: Prescriptions change. How can you avoid clinic visits to reprogram?

The Solution: MedSignals Dashboard lets you program each bin on the web, remotely and effortlessly. The next time the device dials up the server, the new settings will be programmed into the device automatically.

• Scheduled settings are displayed for each bin on a patient's charts.
• You can visually spot when pill patterns change, suggesting a possible prescription change,
• When prescriptions change, you are able to reset times, quantities, and warnings for each drug.

Bands are superimposed over a window of time on user charts to display optimal dosing time. At a glance, investigators can observe a participant’s adherence patterns.

The Problem: Existing electronic data collectors insist on wasting perfectly good devices after monitoring only one drug on only one person for only one study. Then, because the embedded battery expires in 18 months, this $100-investment is cast to the trash. Needlessly.

The Solution: MedSignals are not disposables. You can reuse devices because risk of contamination is controllable. Call MedSignals Help Desk to learn how to sanitize bins yourself. Or, return device to MedSignals to sterilize bins at a nominal fee. Contact MedSignals to learn more about your options.

The Problem: Demonstrating a drug’s true efficacy in FDA trials is a costly, risky, and time-consuming challenge. Demonstrating that the lack of treatment effect is not a result of poor compliance requires sophisticated feedback --and a monitoring device that you can count on.

The Solution: MedSignals is an innovative med-minding device that captures and stores real-time medication compliance data.

• More reliable and frequent measures save time in the field
• Fewer skipped doses for faster results
• Reduce the evaluation period, digitalization time, and specialized personnel before a drug can be commercialized
• Alleviate suffering sooner

The Problem: Using technology to test your own new therapeutic method has not been easy, self-manageable, or inexpensive until now. Programming of a device to execute your new treatment approach often requires pricey consultants and expensive PDAs that are not designed for your intended use.

The Solution:   
When improving adherence is the aim, MedSignals is unrivaled.
Either on the device or online on the webpage, you can individually program each bin to signal and voice-announce instructions according to your study protocols.Ask MedSignals Help Desk how to personalize your instructions simply, record them into devices, and let the pillbox instruct participants right when they open lids to take pills.   

In this crossover study, the difference between experimental condition with signals and control condition with no signals is apparent.

The Problem: Testing injectables, creams, many drugs, and biometrics related to pill-taking?  

The Solution: MedSignals’ pipeline is full of new models with never-before capabilities. You need it -- we probably have it in the works!

Plus the elegant technological platform allows you to mix and match models with functionalities in reasonable volume orders. Drop a note to Marketing and discuss what you have in mind.

Wanting help describing the technology in your grant application? Ask MedSignals Research Manager for our copyrighted tech text that has been used in six successful NIH grant applications.

Needing to talk to a programmer or engineer? Email Help Desk staff to help identify the right expert for your challenge.

Want a proposal for your application? Contact Marketing for volume discounts and ordering online or by phone.

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