AdhereBookTM is our simple, cost-effective software as a service (SaaS) that helps you better manage Clinical Trials, locally or remotely. From Patient recruitment and anonymization, survey data & vitals collection, medication reminders, notifications and adherence reports, remote monitoring and tele-conferencing, AdhereBookTM helps clinical trial participants adhere to your remote or decentralized clinical trials (DCT) regimen and schedule.
Meet patients where they are! Participants never miss their meds, remain connected and monitored 24×7 and you never miss a data point!
No more paper forms to fill, you can remotely interview patients or deliver schedule surveys, online. Data is collected and summarized in real-time. No transcriptions, no personal contact. Better data means a better trial!
With AdhereBookTM:
- Add (unlimited) Participants: add newly recruited participants, invite new ones or assign existing participants to new trials, anywhere in the world;
- Informed consent: readily obtain and archive consent for each participant;
- Establish Projects: Easily setup and manage projects or trials, internationally;
- Record and schedule all medications, regardless of packaging;
- Manage meds in vials, blister packages, sachets, injectables, liquids, in fact any-consumable, anywhere;
- Receive reminders by Email or SMS to any device;
- Communicate securely via video conferencing with those in the circle of care, privately;
- Record medication adherence;
- Record, store and monitor vitals and other health data from any manual or digital health device or sensor;
- Deliver and Complete surveys digitally;
- Record treatment progress & test results;
- Automatically notify clinicians, administrators or caregivers when a dose is missed;
- View adherence reports in real-time;
- Record personal medical history and allergies;
- Record doctors’ appointments or any calendar event as a reminder;
- Manage and monitor 1 or thousands of patients and trials;
- Accessible via mobile phone, tablet/iPad, computer or any internet connected device, anywhere;
- Automated, continuous, secure, encrypted backups;
- Speed up clinical trials, improve participant experience!
AdhereBookTM has a very simple email reminder service that will send you an email or SMS every time you need a reminder to take medications, vitamins, or other participate in other events. Set up reminders as needed. These may be recurring, daily or specific days, or they may be one-time reminders. Enter as much or little details you would like to manage and monitor.
AdhereBookTM includes complete medication management scheduling, confirmations when consumed, and notifications to your circle of care including caregivers, health care providers, clinicians and family. Help is available instantly – when you miss a dose, everyone will be alerted.
AdhereBookTM is a unique service. You can manage all patients and their medications with additional information like medical history, allergies, primary caregiver, family contacts and detailed information for first responders to help you quickly.
Health Care providers and research organizations can use AdhereBookTM to manage and remotely monitor their patients. Instant, secure video conferencing is included, regardless of location. AdhereBookTM is completely integrated with the RxPense®. In fact, you can use AdhereBookTM with or without an RxPense®.
Why AdhereBookTM?
Clinical trials can now support decentralization to broaden access and increase participation. Participants may be directly observed and monitored at a distance, with the most modern videoconference and data capturing technology, AdhereBookTM. Patients are no longer required to “self-report” as technology can assist them automatically. Medication measurement, dosing and Rx records are, similarly, automatic and offer very significant improvements.
Non-compliance has been the subject of much research and the various dimensions of adhesion, and the lack thereof, are well documented. Failure to take medications, to failing to take them at the prescribed time and in the prescribed dose, to therapy discontinued by the patient, all amount to non-adhesion and “bad data”.
The failure of therapy to achieve the desired outcome results, very often, in the clinical assumption that drug failure has occurred when non-adhesion is often the true culprit.
Further, the regulatory compliance for accurate reporting of clinical studies is severely compromised as a result of bad data. Technology, like AdhereBookTM, can assure that “good data” is both collected and available.
ROI
Considering AdhereBookTM for a clinical trial can reduce project costs by tens of thousands of dollars per participant. In addition, schedules can be reduced and compliance to protocols enhanced.
Remote Patient Monitoring and Control
AdhereBook™ Advantage in a Clinical Trials Environment
| Cost Item | Without AdhereBook™ | With AdhereBook™ |
| Home Visits: nurse, assistant or HCP visit to the participant’s home. Once or twice weekly. | Weekly: $200/visit Labour+ T&L (24 months = $20,800 – per participant) | $0 Video, Telemedicine communications and real-time data collection. |
| Participant Site Visits: should participants need to visit the Site. | Weekly: $25 Travel cost, Participant time is unpaid | Weekly: $25 Travel cost or $0 if virtual, Participant time is unpaid |
| Vitals collection | $200/visit nursing to visit remote participant site. Assume 1 visit per week = $20,800. | $0 can be continuously monitored |
| Surveys: submission, data capture, complete, review | Email? Paper, complete and mail in, or telephone survey required: $50/survey. Assume 1 survey / wk = $4,000 p.p. | $0 pushed to AdhereBook™ in the Cloud, completed instantly, data captured and reviewed electronically. |
| Reports: generation of detailed individual and population data | Huge data entry and analysis effort required including transcription of manual diaries. Limited Daily, Weekly or Monthly reports. Eg. Weekly reports: $20,800 p.p. | Included. Real-time and flexible reports can be generated for entire population or subsets. |
| Security: Medication Theft, Loss | Can invalidate participant results. Can poison family, friends or visitors. | Meds are locked and secure if RxPense® is included at participant site. |
| Non-adherence: Participant does not follow the regimen. | Wrong dose (high or low), truthfulness = False data, Errors, Inconsistencies, may invalidate study | Instantly noted and alerts CRO to take proactive action. |
| Hospital Re-admission: when participant is non-adherent or adversely affected by the meds | 10-25% re-admissions due to non-adherence. 1 day=$4000. | Reduced to $0 for non-adherence. Adverse reactions caught rapidly. |
| Integrity: Cost avoidance, data invalidity, should participant not adhere to program | Stipend and costs associated with non-adherent participant data are lost. This also has the effect of increased risk to the project. | By ensuring adherence, study integrity and validity of results are maintained. |
| Study Protocol: complex to follow | Usually difficult to implement and ensure quality assurance. | Benefits of increased automation, real-time monitoring, tracking results and reporting. |
| Recruitment: attracting participants to your clinical trial | Difficult and costly to recruit. Participants view inconvenience, complexity and possible health risk as deterrent. | Easier due to technology advantage. Less work required by participant. Less intrusive to their daily life. Quick response to adverse events. |
AdhereBookTM Features
Patients
This lists all patients accessible to the logged-in user. A Caregiver may have 1 or many Patients to monitor.
Surveys
This presents the survey function and access to existing surveys. Surveys may be customized for each patient and delivered at various times by email or SMS.
Today’s Doses
Displays a summary of medications and dispensing statuses for the current day.
Adherence
A quick view of adherence – taken, missed or skipped.
Vitals
Quick view of recorded vitals with the ability to record new ones.
Contact Information
View, update & validate Patient Telephone Numbers, Email Addresses and Locations.
Emergency Contacts
Displays Emergency Contacts such as Primary Caregiver, Physician, Pharmacist…
NOTE: Emergency contacts are set via circle of care membership profiles. Clinicians, physicians and administrators may receive alerts and notifications to help them better monitor those in their care.
Circle of Care
Patient-authorized caregivers and others who may interact with the patient and portal based on their permissions. You may OPT-IN to receive email and SMS notifications for EACH PATIENT via their CIRCLE OF CARE settings
Care Profile
Patient details including DOB, height, weight, blood type, identifications such as health, insurance and government, Dose settings, location etc…
Allergies
Details and listing of allergies.
Medical Conditions
Details and listing of medical conditions
Notes & Comments
Date and time-stamped notes log. Enter test results, prognosis or personal comments in the patient file.
Video Conferencing
Secure video conferencing, one on one, between patient and caregiver or circle of care member is available, regardless of what platform you access the portal.
Calendar
Displays past and future patient events and appointments. New events can be added and will generate notifications & alerts.
Dose History
Details and status of prior doses.
Prescription Details
Add/view details and listing of prescriptions along with dose and dispensing information.
Reminder Settings
Enable/disable/set time for reminders including dose, notification and other calendar events.
AdhereBookTM Surveys
In addition to monitoring and administering capabilities, AdhereBook can deliver custom-configured surveys to the participant. Before or After dispensing the medications, participants can be asked simple or more advanced questions about their well-being, health or consumption habits.
Clinicians set up the survey online in the portal, to be delivered at specific times, to 1 or many participants. Data collected may be stored with the participant profile or anonymized for further, confidential analysis and processing.
Surveys are displayed to the participant on their mobile phone, tablet or any web accessible device. Participants may respond by tapping the appropriate answer or using their voice to indicate their choice.
Surveys may be a simple as a single yes/no question or as complex as ratings and conditional display logic conditions. Consolidated reports are available to the administrator with a simple click.
AdhereBookTM Simple, No-nonsense Pricing
Research Organizations: $500/Clinical Trial, setup of dedicated portal and URL.
Participants: $10/patient/month, min $100/yr until project completion.
Consulting, Training, Bulk Imports, Archiving: Request a Quote.
AdhereBookTM – How to Get Started
Patients access the Portal with their favorite tablet or personal computer and can then enter all their personal details, caregivers, contacts, physicians, pharmacies, medical history, test results and medications and thereafter have full access to their medication history and other details.
Clinical Research Organization
Complete the AdhereBook Trial Application form and submit it so we may properly validate your account and then set it up in the AdhereBook portal. You will be sent an email invitation from AdhereBook as soon as your account has been established.
Clinical Trial Participants
Sign up for a trial, enter your personal details and submit your request to the CRO. When accepted, you will be contacted and provided with a link and login code to access AdhereBook.
FDA 21 CFR Part 11 Compliance
21 CFR Part 11 regulations set forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.
The software development methodology and quality system that is in place at Medipense along with the functionalities of the cloud-based software have been 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.