mobile Clinical Trial Automation (mCTA)
What is mCTA?
mCTA is a suite of services (mComply and mRecruit) using mobile apps or two-way text messaging and business intelligence technology to improve the patient recruitment and retention processes, improve study compliance, realize high medication adherence and automate tasks.
Why use mCTA?
As mobile phones are always on, always connected and always with the patient, mCTA allows you to communicate directly with patients in real-time to address recruitment delays, patient retention, and low medication adherence rates. Our solutions range from dedicated mobile devices, site-based devices used in the physician’s office, to BYOD options (native smartphone apps, IVRS, text messaging and web-based applications) that can be used in any environment. 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, EU Directive 2002/58/EC, local text messaging regulations and local privacy laws. We can provide a checklist of how our applications comply with major industry standards.
Our leading service, mComply is a customizable, cloud-based system allowing sponsors to help patents follow a medication regimen and subsequently improve compliance. It 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.
- Participant Engagement Channel. Participants (e.g. patients, study coordinators, sponsor, third-parties) can submit or obtain information through different channels.
- Application. Modules are customized according to functional requirements supporting the study protocol. These include the various interventions supporting study compliance and the infrastructure processes including registration, randomization setup, opt-out, and escalation workflow.
- Backend Interface. A web portal allows study coordinators to securely access all the data sent/received between the patients and the Application. The web portal is used to enroll, withdraw and manage patients; access pre-defined reports; export data; and manage study performance.
How does it Work?
- Enroll. Study coordinators can easily enroll patents via a secure web portal or patents can enroll directly by sending a registration text via SMS or through a mobile app. Conversely, patients can opt-out via mobile phone at anytime or have a study coordinator do it on their behalf. Moreover, mComply can support enrollment through sequential phases e.g. registration and randomization.
- Engage. Available engagement tools include 1-way or 2-way study appointment and medication reminders via text messaging or mobile app, collecting diary entries or feedback from patients, helping patients visualize study progress, rewarding patients for adhering to study outcomes through gamification, and providing motivation messages among others.
- Manage. 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.
- Analyze. Study coordinators can review, analyze and extract all patient data via the web portal. Insights into study performance can be provided across various levels including patient, site and geography.
Request our brochure mComply: Running Successful Clinical Trials – Adherence Delivered to understand the productivity improvements and cost / revenue benefits this solution can bring.
With adherence rates in clinical trials ranging from 39% – 63% for prevention trials and 59% – 78% for treatment trials, compliance tools are instrumental to realising successful trials.
Use Case: Send Reminders to Perform ANY Task
Send timely and effective appointment, medication and diary entry reminders via text message or mobile app notifications. Patients are motivated and reminded to adhere to study protocols after receiving timely inspirational and informative messages. Consequently patients regularly achieve high medication adherence rates and are comforted by the notion that someone is watching over them.
mComply allows you to send timely, effective and personalized text message reminders to patients:
Appointment 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.
Medication Adherence. Remind patients to take or apply medication and/or provide instructions on how to take or apply treatment medication.
Diary Reminders. Remind patients to make diary entries.
Motivational Messages. Send inspirational and informative messages to motivate patients and remind them of the importance of adhering to study protocols.
mComply supports text messaging to effectively remind patients of their required activities. 97% of text messages are read… and read instantly.
Use Case: Collect Patient Recorded Outcomes (ePRO) or Perform a Survey
Automate the submission of diary entries through the mobile phone. Study participants can use mComply as the primary diary, or as a compliment to existing diaries to collect key information. As a result of online entry, study coordinators and specialists are automatically alerted as protocol violations or health concerns arise.
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.
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.
Monitoring. Monitor patient activity to ensure that they are performing the required activities at the required times.
Intervention. Escalation protocols are used to send reminders to patients if expected data is not submitted, or to send alerts to research sites regarding protocol violations or health concerns.
mComply utilizes the availability of mobile phones to improve patient diary compliance, to capture key information in real-time, and to ensure that patients are completing their required tasks.
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 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.
mCTA is Available across all Platforms and Devices
mCTA is a validated system, customizable to suit any clinical trial need and can be used with both smartphones (iOS, Android, Blackberry, Windows) and feature (i.e. basic) phones to achieve study objectives. Some text messaging examples using feature phones are shown below.
Smartphones vs. Feature Phones (i.e. basic phones)
Not everyone has a smartphone. A 2015 Pew Research Study showed that the median smartphone penetration in advanced economies1 was 68% as compared to 37% found in emerging/developing economies. Moreover the statistic for advanced economies is weighed down by the 35+ age group with a median smartphone penetration of 60% as compared to 91% of adults in the 18-34 age group. Thus 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). Not surprisingly, an earlier Pew Research Study showed that the “Big Four” smartphone apps2 and feature use were: text messaging (97%), voice/video calling (92%), internet (89%), and email (88%).
1 Advanced economies include: US, Canada, UK, Germany, France, Italy, Spain, Israel, Australia, Japan, and South Korea.
mCTA is Available World Wide
mCTA 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).
Synegys provides mobile Clinical Trial Automation solutions based on a secure text messaging platform or native 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 mCTA solution.