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mComply_Brochure_v1.0c.pdf

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POWERED BY
mCOMPLY
Running Successful Clinical Trials - Compliance Delivered.
mComply - Adherence Delivered.
mComply - Adherence Delivered.
2 3
mComply
Compliance is an important determinant of clini-...
mComply - Adherence Delivered.
mComply - Adherence Delivered.
4 5
Nonadherence occurs as participants deviate from treatme...
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mComply_Brochure_v1.0c.pdf

Compliance is an important determinant of clinical trials and can be improved through effective participant engagement. This paper describes how Synegys' AI-powered platform uses AI to improve medication adherence by sending reminders only when necessary, using natural language processing, automatically generating responses, and personalizing messages based on a patient's preferences and past interactions. The solution can be delivered using text message services and/or mobile web app channels.

Use mComply to:
- Promote adherence through effective appointment, medication and diary entry reminders. Motivate and remind participants to adhere to study protocols.
- Monitor how well participants are progressing through the automated submission and processing of participant diary information.
- Alert Site Coordinators or a wider support network regarding protocol violations or health concerns.

Synegys' mComply offers a significant impact on patient outcomes and is a powerful tool for improving medication adherence and overall study compliance to Study Sponsors, Contract Research Organizations, Research Sites, and Patient Recruitment Agencies

Compliance is an important determinant of clinical trials and can be improved through effective participant engagement. This paper describes how Synegys' AI-powered platform uses AI to improve medication adherence by sending reminders only when necessary, using natural language processing, automatically generating responses, and personalizing messages based on a patient's preferences and past interactions. The solution can be delivered using text message services and/or mobile web app channels.

Use mComply to:
- Promote adherence through effective appointment, medication and diary entry reminders. Motivate and remind participants to adhere to study protocols.
- Monitor how well participants are progressing through the automated submission and processing of participant diary information.
- Alert Site Coordinators or a wider support network regarding protocol violations or health concerns.

Synegys' mComply offers a significant impact on patient outcomes and is a powerful tool for improving medication adherence and overall study compliance to Study Sponsors, Contract Research Organizations, Research Sites, and Patient Recruitment Agencies

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mComply_Brochure_v1.0c.pdf

  1. 1. POWERED BY mCOMPLY Running Successful Clinical Trials - Compliance Delivered.
  2. 2. mComply - Adherence Delivered. mComply - Adherence Delivered. 2 3 mComply Compliance is an important determinant of clini- cal trials and can be improved through effective participant engagement using mComply. Achieve high adherence rates by sending par- ticipants timely messages including appoint- ment, medication and diary entry reminders, and motivation messages. Automate the submission of diary entries through the mobile phone. Why mComply? The ubiquity of mobile devices, combined with their personal nature and text messaging func- tionality, make mobile phones an effective plat- form for delivering health interventions. mComply is a validated, CFR-compliant mobile messaging system supported by over 1,200 mo- bile network operators in 200 countries. mComply is configured and customized to fit ANY trial need. Promote adherence through effective appointment, medication and diary entry reminders. Motivate and remind partici- pants to adhere to study protocols. Monitor how well participants are pro- gressing through the automated submis- sion and processing of participant diary information. Alert Site Coordinators or a wider sup- port network regarding protocol viola- tions or health concerns. The case for mComply Situation Implication Solution Prevalence of Nonadherence Significant Financial Impact mComply Mean adherence rates in clinical trials for ap- pointment keeping, short-term medication-tak- ing, and long-term medication-taking have been estimated to be 39%, 62%, and 63% respectively for prevention trials and 78%, 78%, and 59% for treatment trials.1 Linear increases in nonadherence have an ex- ponential effect on the volume of participants you need to enrol in order to achieve the same statistical outcome for a trial. Enrolling additional participants will increase drug development costs and the associated opportunity cost for time and capital. Assuming a nonadherence rate of 30% in a typical Phase 2 study, a 1% improvement would deliver nearly $400,000 in cost sav- ings.2,3,4,5,6,7,8 mComply helps your study achieve the level of participant compliance and retention your trial needs to stay on track for success. The solu- tion focuses on text messaging interventions, a ubiquitous approach to realize adherence rates in excess of 97%. mComply is also available in mobile app and web app form with extended capabilities; however, at the cost of service ubiquity.
  3. 3. mComply - Adherence Delivered. mComply - Adherence Delivered. 4 5 Nonadherence occurs as participants deviate from treatment protocol e.g. forgetting to take doses, taking medications at incorrect times, taking an incorrect dose or missing study visits. Nonadherence by participants can lead to underestimated harms, misinterpretation of results, type II error and low statistical power - all leading to increased costs. A study found that 40% of participants become non- adherent to investigational medical product (IMP) after 150 days. Furthermore, IMP nonadherence “not only causes temporary bouts of toxicity (double dosing) and lack of efficacy (skipping doses), but also introduces data variability into the equation.”13 A meta-analysis of trials of interventions to improve medication adherence showed increases in adher- ence in the range of 4% - 11%.9 This was achieved through two types of interventions: behavioural and educational. Compliance Medication adherence may be defined as “the extent to which a person’s behaviour (in terms of taking medications, following diets, or executing lifestyle changes) coincides with medical or health advice.”12 Not to be confused with “compliance”, “adherence” acknowledges participants’ participation in the treatment process. Compliance on the other hand, implies subservience on the part of the participant with a focus on the PROVIDER’S goals. Nonadherence in Research Settings In clinical trials, medication adherence averages 75% and appointment-keeping ranges from 39-78%.1,14 Behavioural Interventions included the use of any tool or action that would change a participant’s skill level or nor- mal routine, including reminders, and dosage-schedule changes. Educational interventions were those that taught the participant about the medication and how to take it through oral, written, or audiovisual communica- tion. Pathways to Adherence Financial Impact Drug development has two main cost components: the actual costs for drug development and the opportunity cost for time and capital. Medication nonadherence forces study teams to enrol more participants, resulting in higher operating costs and missed trial deadlines. More Participants Higher Operating and Opportunity Costs Addressing Nonadherence - The Case for mComply Using Synegys’ mComply, study teams can manage behaviours that impact costs. Consider a scenario of running a Phase 2 study with 203 participants at 30% noncompliance. Each participant is to fol- low a medication regimen every 3 days for 3.5 months with study appointments every month. Reducing IMP nonadherence to 3% to maintain equivalent statistical power results in nearly $12 million in cost of capital savings. When only considering variable operating ex- penditures, $1.5 million can be saved through lower enrolment and retention costs, reduced compliant episodes, improved data collec- tion and reduced “no-shows”.3,4,5,6,7,8 Linear increases in nonadherence has an expo- nential impact on the number of participants needed to yield the same statistical outcome.4 For example, a 20%-30% decrease in investiga- tional medicinal product (IMP) adherence may result in increasing the participant sample size by 50% in order to maintain sufficient statistical power. Assuming a constant 30% IMP nonadherence rate for a typical Phase 2 trial, sponsors need to enrol additional participants in order to maintain equivalent statistical power. The cost for for participant enrollment and retention for a typical study is estimated at $13.3 million. By reducing nonadherence by 1% (to 29%), sponsors need to enrol less participants to maintain equivalent statistical power, resulting in nearly $400,000 in cost savings, and naturally, minimizing timeline slippage.2,3,4,5,6,7,8 Note: We’ve expanded on Alsumidaie’s15 original analysis by considering an IMP nonadherence rate of 30%, including direct variable cost categories (participant retention, registered nurse/CRA, physician, clinical procedure and central lab costs) and inflating the sample size by the square of people expected to not comply rather than using an imputed linear sample size multiple. Adherence Rate with mComply 97.5%
  4. 4. mComply - Adherence Delivered. mComply - Adherence Delivered. 6 7 mComply mComply helps participants follow a medication regimen and subsequently improves study compli- ance. It supports any front-facing, communications interface including any one or combination of text messaging (i.e. SMS), mobile app, email, interactive voice response, web app or live agents. Given that text messaging offers instantaneous relay of information and boundless reach, this paper focuses on the text messaging engagement channel. Participant Engagement Channel Application Backend Interface Participants submit or obtain information via different channels. Notifications are best delivered via text messaging given its ubiquitous nature. mComply is fully compliant with local text messaging regulations and messages are local- ized with diacritic support. The mComply platform is configured and modules are customized according to functional requirements supporting ANY study protocol. Alongside the Appli- cation is a secure database containing study data. A secure web portal acts as the backend interface. Study Coordinators can se- curely access all the data sent/received between the participants and the Ap- plication. The web portal is used to enrol, withdraw and manage participants; access pre-defined reports; export data; and manage study performance. Dif- ferent access privileges can be assigned to different user groups. How does mComply work? Study Coordinators can easily enrol participants via a secure web portal or participants can enrol directly by sending a registration text. Conversely, participants can opt out via mobile phone at anytime or have a Study Coordinator do it on their behalf. Enrol Available engagement tools include sending 1-way or 2-way study appointment and medication re- minders, collecting diary entries or feedback from participants, helping participants visualize study progress, rewarding participants for adhering to study outcomes through gamification, and provid- ing motivation messages among others. Engage Reminders and appointment schedules can be managed online. Escalations are logged as they arise and are flagged until they are addressed. An audit trail is maintained as Study Team members add, edit and delete data. Manage The Study Team 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. Analyze
  5. 5. AUSTRALIA KENYA mComply - Adherence Delivered. 9 Medication adherence is critical to a clinical trial’s success. Introducing a simple and effective communication tool like text messaging can im- prove study compliance. “ Text Messaging - A Ubiquitous Solution A feature of mobile health interventions is the potential for scal- ability owing to affordability and ability to deliver personalized services. Mobile phone interventions that focus on text messag- ing have particular value, because they do not require a smart- phone and are agnostic to the mobile operating system. Further- more, most people across all income groups own a mobile phone. With global mobile penetration reaching 103% in 201910 , a text message–based intervention has the potential to have substan- tial population effects. UNITED STATES Smartphone Penetration By Age Group (%)11 Smartphones as Percentage of all Mobile10 5.2+ Billion Unique Mobile Subscribers10 65% Smartphone Connections10 HUNGARY
  6. 6. 1 2 3c 3d mComply - Adherence Delivered. mComply - Adherence Delivered. 10 11 Operationalizing mComply in Clincal Trials Participants need to sign a consent form before using mComply. During this process, par- ticipants are informed about system benefits, participant’s role, opt-in / opt-out capabilities, costs and privacy. Moreover, participants are provided with support materials to use the system. Once consent is obtained, participants are registered via the mComply web portal or via the participant’s mobile in real-time. Study Team Obtains Consent and Registers Participants 3a The participant submits a time-stamped diary entry with relevant details associated with dose information. This can be through a single submission or through multiple interactive messages, depending on what information is required. In the example below, a participant informs mComply that three 150mg capsules were taken on February 15 at 8:40pm and his last meal was at 5:30pm. Participant Submits Diary Entry Following a review of your study protocol and discussions with the study team, we configure and customize mComply to satisfy your study’s needs. Unlike general reminder and adherence solu- tions in the market, mComply can accommodate complex dosing regimens and support overall study workflow. If a diary entry was not received after a pre- determined number of sent reminders or timeframe, an escalation can be raised with the Site and Study Coordinators via text mes- sage or email. The Study Team can visit the web portal to review the escalation details and intervene according to agreed protocol. mComply Sends Escalations based on Pre-defined Logic Based on user access levels, Study Team members can edit / delete doses and partici- pants’ profiles (e.g. dose amount, dose times, drug type, etc.). An audit trail of all changes made by whom and at what time is main- tained. Study Team Manages Participants and Diary Entries If a submission is not received when expected by mComply, reminders are sent until the par- ticipant submits a diary entry. Reminders are specific to each participant and can be sched- uled for ANY time interval and can include exceptions. mComply Sends Reminders based on Pre-defined Logic 3b 3e
  7. 7. mComply - Adherence Delivered. mComply - Adherence Delivered. 12 13 mComply Applications 97% mobile phone users read text messages within 15 minutes. SMS / text-based programs are the most simple, straightforward, and effective for getting information to people and allowing them to interact quickly. mComply offers a tailored approach based on optimal timing, adaptation and content. With customizable logic applications and conditional triggers, mComply fully sup- ports organizations to collect data and to improve adherence. Send messages with further assistance, informa- tion, and feedback to users (or AI-driven chat services) depending on answers. If a user indi- cates that they’re symptomatic, for instance, auto-responses can provide guidance on testing centers, hospitals and general care. Have participants come fully prepared on their next site visit. Send messages informing par- ticipants how to prepare for their next visit (e.g. treatment, fasting, etc.) or what to bring with them (e.g. remaining medication, diary, etc.). Wellness Checks Visit Preparation Reminders Remind participants to take or apply medica- tion and/or provide instructions on how to take or apply treatment medication. Deliver tailored content based on the type and cause of nonad- herence and participant needs. Schedule visits on our web portal and have re- minders sent on when to attend, how to confirm and/or how to reschedule. Send a text three days prior to the appointment as a general reminder, or 24 hours prior as a final reminder. Make your participants feel supported and ap- preciated. Send timely messages with the sole purpose of educating and motivating the par- ticipant. This helps them stay on track with their personalized healthcare plans and recommenda- tions. Collect data using text message surveys / ques- tionnaires. Qualify and recruit participants for studies using interactive text chat. Various types of response formatting are available, including multiple choice and user-defined phrases. Medication Reminders Appointment Reminders Motivation & Info Messages Surveys & Questionnaires
  8. 8. mComply - Adherence Delivered. mComply - Adherence Delivered. 14 15 Project Description mComply is configured and applica- tion logic customized to support study protocol requirements. Derived from over 15 years of experience, our patient engagement tools and processes help health organizations engage patients, improve outcomes and lower costs. DEFINE MODEL VERIFY DEPLOY “ DEFINE MODEL VERIFY DEPLOY √ √ Project Plan √ √ Requirements √ √ Design √ √ IRB Documents √ √ Solution Build √ √ Design Review √ √ Data Setup √ √ System Testing √ √ User Acceptance Testing √ √ Training √ √ Go-Live √ √ Support & Mainte- nance Every study is different. Implementing an “off- the-shelf” technology solution will have mini- mal impact on adherence, if at all. Leverage our experience and technical know-how to develop a solution that will deliver against your study protocol. mComply is supported by over 1,200 mobile operators in 200 countries. 1-way and 2-way messaging is supported along with diacritics. mComply is validated against the specifications set forth by your study protocol. The solution is 21 CFR part 11 compliant, HIPAA-ready, and is compliant with GDPR, local text messaging regu- lations and local privacy laws. To successfully deliver a participant compli- ance system, you also need to consider training guides, IRB documentation for mComply, par- ticipant consent forms, translations and the like. We can help you realize a compliance system on time and on budget. Customization Service Coverage Compliance Comprehensive Delivery Why Synegys? Confirm overall study ob- jectives and develop a set of functional requirements. Formulate SMS content, configure platform and customize application logic. Develop IRB documenta- tion for submission. Program, setup, test and prepare mComply for vali- dation. Train the study team and prepare supporting docu- mentation. Host and main- tain mComply until trial completion.
  9. 9. mComply - Adherence Delivered. mComply - Adherence Delivered. 16 17 References 1. Robiner, William N. Enhancing adherence in clinical trials. Contemporary Clinical Trials. 2005;26:59–77. 2. Synegys Analysis. Source of information used in this analysis for aggregated clinical trials and patient average data: www.clinicaltrials.gov via www.karmadata.com. Cost elements sourced by Medidata Solutions. 3. Eastern Research Group, Inc. Examination of Clinical Trial Costs and Barriers for Drug Develop- ment. July 25, 2014. 4. Wittes, Janet. Sample Size Calculations for Randomized Controlled Trials. Epidemiologic Reviews. Vol 24, No. 1, 2002. 5. Damodaran, Weighted Average Cost of Capital for drugs (biotechnology). http:/ /people.stern.nyu. edu/adamodar/New_Home_Page/data.html. Updated Jan 5, 2018. 6. CMR International. Pharmaceutical R&D Factbook 2011. Thomson Reuters, May 2011. 7. DiMasi, Briefing - Cost of Developing a New Drug. Nov 18, 2014. https:/ /csdd.tufts.edu/cs- ddnews/2018/3/9/march-2016-tufts-csdd-rd-cost-study. 8. Biotechnology Innovation Organization. Clinical Development Success Rates 2006-2016. 2016. 9. Andrew M. Peterson, Liza Takiya, Rebecca Finley. Meta-Analysis of Trials of Interventions to Im- prove Medication Adherence. Am J Health Syst Pharm. 2003;60(7). 10. GSMA 2021. 11. Pew Research Center 2020. 12. Meichenbaum D, Turk DC. Facilitating Treatment Adherence: A Practitioner’s Guidebook. New York: Plenum; 1987. 13. Blaschke TF, Osterberg L, Vrijens B, Urquhart J. Adherence to Medications: Insights Arising from Studies on the Unreliable Link Between Prescribed and Actual Drug Dosing Histories. Annu Rev Pharmacol Toxicol. 2012. 14. Dimatteo et al. Variations in Patients’ Adherence to Medical Recommendations. Med Care. 2004;42:200-209. 15. Alsumidaie Moe, Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost, Applied Clinical Trials, Apr 2017. William Eng Managing Director  +420 736 767 732  william@synegys.com Contacts  Americas & Asia-Pacific: +1 403 708 3910  Europe & Africa: +420 603 429 748  info@synegys.com Á www.synegys.com Á www.mobilehealthworks.com This publication has been written in general terms and we recommend that you obtain pro- fessional advice before acting or refraining from action on any of the contents of this publica- tion. Synegys s.r.o. accepts no liability for any loss occasioned to any person acting or refrain- ing from action as a result of any material in this publication. © 2018, 2021 Synegys s.r.o. All rights reserved.
  10. 10. Contact Information Synegys s.r.o. Washingtonova 1567/25 110 00 Prague 1 Czech Republic info@synegys.com www.synegys.com

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