Improve Medication Adherence and Study Compliance Using mComply
What is mComply?
mComply is an AI-powered, customizable, cloud-based system for study teams to improve medication adherence and study compliance. The solution supports any front-facing, communications interface including any one or combination of text messaging (i.e. SMS), mobile app, email, interactive voice response (IVR), web portal or live agents.
mComply is a comprehensive, modular mobile health solution. Application modules improve workflow and automate tasks to support medication adherence and study compliance. The solution is available using a secure text messaging platform, mobile app, or web app. As text messaging is available on ALL mobile phones, this is the preferred platform of choice for many of our health clients.
Why use mComply?
mComply is a mobile-based solution that utilizes the “Bring Your Own Device” (BYOD) approach, allowing you to use participants’ own phones to communicate with them in real-time. This approach is more cost-effective compared to using proprietary devices and allows for better patient retention and medication adherence. mComply offers two-way communication, notifications, and data collection methods that are accessible on all mobile platforms and phones. Our validated system meets regulatory and functional requirements, including 21 CFR Part 11, HIPAA, GDPR, and local text messaging and privacy regulations. We can provide a checklist of how our applications comply with major industry standards.
How does mComply improve medication adherence and study compliance?
Study coordinators can easily register participants via a secure web portal. Alternatively, patents can enrol directly by sending a registration text via SMS to receive activation information.
Recruit participants by adding a mobile call-to-action to your existing advertising. Participants can enrol and be pre-screened via text messaging or via a url text to a questionnaire.
Interact with participants using 1-way or 2-way text messaging, a native mobile app or web app (i.e. online internet).
Send appointment and medication reminders, collect dosing entries or feedback from participants, help patients visualize study progress, reward patients for adhering to study outcomes through gamification, or provide motivation messages.
Applications (see below) can be configured and built to effectively interact with your participants.
Use a secure web portal to manage your study.
Reminders and appointment schedules can be managed online. Escalations are logged as they arise and are logged until they are addressed. An audit trail is maintained as study coordinators add, edit and delete data.
Study coordinators and Sponsors can review, analyze and extract all participant data via the web portal. Insights into study performance can be provided across various levels including participant, site and geography.
Application Modules are Configured and Customised to Fit Any Need
mComply is configured and tailored to fit any requirement. This is performed by combining our Application Modules in any fashion and customising each module’s logic as necessary. Key health application modules include: text message reminders & notifications, data collection, alerts & escalations, appointment scheduling, tele health / Online video and patient recruitment.
Reminders are system-initiated and are AI-based
Send timely and effective appointment, medication and diary entry reminders via text message or mobile app notifications. Motivate and remind participants to adhere to study protocols after receiving timely inspirational and informative messages. Our reminder system is based on pre-defined logic and tailored to any organisational need. Reminders are managed centrally can be customised according to specific times, regular or irregular time frames, individual schedules and include exceptions.
- Medication Adherence – Remind patients to take or apply medication and/or provide instructions on how to take or apply treatment medication.
- Appointment & Visit Preparation Reminders – Schedule visits on our web interface and have reminders sent on when to attend, how to prepare, what to bring, how to confirm and/or how to reschedule.
- Notifications & Informative Messages – Notify patients of important actions and events (e.g. registration confirmation, instructions to use a service or to perform a task, profile updates such as changes in dose amount or dose times, status updates such as dosing paused, dosing complete or study complete, etc.)
- Diary Entry Reminders – Remind patients to make diary entries.
- Education & Motivational Messages – Send inspirational and informative messages to motivate patients and remind them of the importance of adhering to study protocols.
Automate the submission of diary entries through the mobile phone. This module allows you to collect diary entries, perform wellness checks, conduct surveys and help you with any data collection.
- Data Collection. Use as the primary patient reported outcome (PRO) tool, or as a compliment to existing diaries to collect key information that you would like to analyze and view in real-time.
Guide participants through a question and answer workflow to maximise efficiency and data quality. Questions can be configured to trigger alerts or to create new events based on a participant’s response.
Data Quality. Ensure realtime data validation with structure data input fields. Time-stamped data assures analysts that all responses were recorded at the appropriate time, rather than after the fact (referred to by the FDA as the Parking Lot Syndrome).
Data Variety. Utilize smartphone functionality like the camera to take photos as part of a diary submission.
Data Management. Simplify data management for sites and sponsor from the automatic capture of patient recorded outcomes.
Intervene when escalations are triggered
Sites can be alerted via text message or email when there are protocol violations or health concerns. Escalations are logged as they arise and are flagged until they are addressed. For example, if a diary entry was not received during the expected dosing window, an escalation is logged on the web portal and the study coordinator is alerted to review the escalation details and intervene according to the agreed protocol.
Appointment Scheduling for Study Trials
Booking System for Medical Practices
Schedule appointments for research and clinical trial participants. Have a centralised system where appointment reminders are automatically scheduled and tailored to a study’s protocol.
Medical & Health Services
Automate patient bookings, cancellations, reminders and payments using a web-based appointment scheduling system. Patients can schedule their appointments directly online. Manage both patients and staff schedules. Eliminate no shows and missed appointments using a reminder system to send SMS and emails to both staff and patients at preset times prior to the appointment.
Provide medical consultations and support remotely
Telehealth has surged during the Covid pandemic as consumers and providers sought ways to safely access and deliver healthcare. Based on a McKinsey Study1, around 40% of surveyed consumers stated that they believe they will continue to use telehealth going forward – up from 11% of consumers using telehealth prior to the Covid pandemic.
Offer telehealth services via a secure, one-on-one online video conferencing solution using a computer, smartphone or tablet.
1“Telehealth: A quarter-trillion-dollar post-COVID-19 reality?”, McKinsey, July 2021.
Automate the patient recruiting process by pre-screening patients through interactive questions and answers via the mobile phone, and directing pre-qualified patients to the appropriate research sites.
mRecruit is an interactive tool, promoting study awareness with prospective patients. It can provide a description of the Study, describe how a Study works and can determine the eligibility of a patient. Moreover if a patient is eligible to participate in a clinical trial, the application can direct the patient to the nearest study site based on the patient’s current GPS location.
mRecruit allows you to add a mobile call-to-action to your existing advertising:
Potential patients can download a study-sponsored mobile app via QR codes or links shown on existing online or offline advertising, including social networking sites, email, posters and leaflets. With feature or basic phones, patients can respond to an ad by texting a keyword to a mobile number (or short code), for example “Text DIABETES to 46786”.
Patients answer a series of pre-defined questions to determine their eligibility to participate in the trial.
If they qualify, patient information is passed on to the appropriate research sites for follow-up.
Request our Patient Recruitment Business Case to see the financial and productivity gains of this solution.
mRecruit increases response rates by up to 30%, shortens trial timelines, improves recruitment efficiencies.
See mComply in action
mComply is Available across all Platforms and Devices
mComply is a validated system, customizable to suit any clinical trial need and can be used with both smartphones (iOS, Android) and feature (i.e. basic) phones to achieve study objectives. Complex workflows are often supported using a web / mobile app. Text messaging can be used to support ALL mobile phones, and our experience and expertise can ensure this technology can be used to support more complicated workflows.
Web / Mobile App
Smartphones vs. Feature Phones (i.e. basic phones)
Not everyone has a smartphone which can support web / mobile apps.. Feature phones are the basic cell phones without apps and complex OS systems, but offers text messaging features like smartphones. There was 6.2bn smartphone connections in the world, representing 75% of all mobile connections. This was 82% in North America compared to 64% in Sub-Saharan Africa.1 Diving into these numbers reveal differences in smartphone usage by demographic. For example in the US, smartphone penetration in the 18-49 age group is 95%. This drops down to 71% for the 50+ age group.2 Depending upon your study requirements, you might want to engage people using a text messaging solution available on all phones (and is inherently available with smartphones).
2 Pew Research Center (2021), Synegys Analysis
mComply is Available Worldwide
mComply is supported by over 1,200 mobile operators in 200 countries and is fully compliant with local text messaging regulations, the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA), 21 CFR Part 11, the EU Directive 2002/58/EC (ePrivacy), EU 2016/679 GDPR (General Data Protection Regulation) and the Food and Drug Administration Guidance for Industry Patient Reported Outcome Measures (December 2009).
Clinical Trial Automation solutions are based on a secure text messaging platform or mobile apps to Study Sponsors, Contract Research Organizations, Research Sites, and Patient Recruitment Agencies around the world. Moreover, Synegys will assist with preparing local regulatory submissions pertaining to the mComply solution. Custom solutions can be developed leveraging our industry and technical expertise to create a seamless multi-level program tailored to specific patient populations.