Using mComply in Clinical Trials & Research Studies

What is mComply?

mComply is a customizable, cloud-based system for sponsors to help patients follow a medication regimen and subsequently improve 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, automate tasks and deliver compliance and adherence. 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.

mComply is a validated, cloud-based solution helping you improve the patient recruitment and retention processes, improve study compliance, realize high medication adherence and automate tasks. The solution is deployed using mobile apps or two-way text messaging and artificial intelligence.

Participants

Mobile Phone

Mobile Phone

Participants submit or obtain information via text messaging available on ALL mobile phones. The user interface can also be on web or mobile app.

mComply Solution

Validated, CFR Compliant

Validated, CFR Compliant

Application modules are customized to support your study protocol. These include interventions supporting study compliance and infrastructure processes such as recruitment, registration, dosing schedule, appointments, reminders, wellness checks and escalation workflows.
Participants submit or obtain information via text messaging available on ALL mobile phones. The user interface can also be on web or mobile app.

Health Organization

Web Portal

Web Portal

Based on user-access levels, team members can securely access all the data sent / received, export data and manage performance.

Why use mComply?

Proprietary devices are expensive to to use in research studies and clinical trials. mComply takes the BYOD, or “Bring Your Own Device” approach focusing on mobile phones. These devices are always on, always connected, and always with the participant, allowing you to communicate directly with patients in real-time to address recruitment delays, patient retention, and low medication adherence rates. We enable you to engage patients through two-way communications, timely notifications and data collection methods accessible across ALL mobile platforms and phones.

Electronic systems are validated against the specifications set forth by regulatory and/or functional requirements.  This includes 21 CFR part 11, HIPAA, GDPR, local text messaging regulations and local privacy laws. We can provide a checklist of how our applications comply with major industry standards.

How does mComply work?

Enrol

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.

Engage

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.

Manage

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.

Medication Reminder
Appointment & Visit Preparation

Reminders are system-initiated and are based on pre-defined logic

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.
 
2-way Messaging: Patients can reply to incoming messages. The purpose of the reply is to acknowledge that a specific action was performed or to confirm an intended action/activity (e.g. dose taken, diary entry confirmation, registration, etc.)
 

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

Study Trials

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:

  1. 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”.

  2. Patients answer a series of pre-defined questions to determine their eligibility to participate in the trial.

  3. If they qualify, patient information is passed on to the appropriate research sites for follow-up.

Request an mRecruit 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.

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:

  1. 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”.

  2. Patients answer a series of pre-defined questions to determine their eligibility to participate in the trial.

  3. If they qualify, patient information is passed on to the appropriate research sites for follow-up.

Request an mRecruit 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.

How does it work?

Register Participants

Study coordinators can easily enroll patents via a secure web portal or patents can enroll directly by sending a registration text via SMS to receive activation information or a url text to download a secure mobile app.

Engage with Participants

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, and provide motivation messages.

Manage Study via a Secure Web Portal

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.

Review, Analyze and Extract Study Data

Study coordinators 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.

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
Text Messaging

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). 

1 GSMA (2022)

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), 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 in 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.