![Study Snapshot eMail
Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
From: IVRCC Snapshot [mailto: @ivrcc.com]
Sent: Tuesday, August 20, 2013 10:05 AM
To: Nancy Hudak
Subject: - Study Snapshot - Week 18 of enrollment
Attached is the study snapshot report for the study.
Feasibility of a Using a Structured Daily Diary to Assess…
Enrollment started on April 16, 2013 with target enrollment of 90 subjects in 72
weeks.
At current enrollment rate of 2.00 subjects per week, it is estimated to enroll the
remaining 55 subjects in 27 weeks, February 2014
At best enrollment rate of 7.00 subjects per week, it is estimated to enroll the
remaining 55 subjects in 11 weeks, November 2013](https://image.slidesharecdn.com/ivrccintroductioncapabilities-27jan2017-170503190824/85/IVR-Clinical-Concepts-RTSM-ePRO-eCOA-eSource-Solutions-25-320.jpg)
IVR Clinical Concepts RTSM & ePRO/eCOA eSource Solutions
- 2. Agenda • Introduction • IVR Clinical Concepts Company History • Product Services • Reports, Notification, Exports • Customer Care (Helpdesk)
- 3. IVRCC History & Timeline 2010 Administrative & sales HQ in NY, dedicated IVRS staff in Boca Raton, FL continual system and security upgrades Expand mobile IMR device usability, better user interface, web- hosting, security 2013 2015 Continue growth, improvement and client education 1991 1996 2003 2004 2006 2007 2008 2009 2010 2013 2015 Expand to IWRS, for better subject and trial staff use 2009 2008 Acquire IVR Concepts – platform & process upgrades, SOPs, security improvements IVR Clinical concepts incorporate, FDA Guidance accepting data meeting ALCOA specs 2007 2006 IVR Concepts, LLC, interactive web board for trial staff, to enter patient information, PINs, inclusion/exclusion, demographics,& for EDC integration Passive web board - trial personnel to access their subject activity information directly 2004 2003 Partnership with Phone Interactive Communications Co. (PICC), a Boca Raton, FL platform and IVR service provider. Fax/IVR integration, alerts/ notifications 1996 1991 Trademark for early iteration of new solution, TeleDiary™ ediary, for data collection from subjects 2017 Deploy mobile site tablets for Rater evaluation, continued enhancement of patient engagement 2016 2016
- 4. Core Competencies of IVRS-IWRS Screening, Registration, Randomization CTM Management eCOA, ePRO eIntegration • Subject Recruitment, Screening, Registration, Randomization • Clinical Trial Material (drug-device) Supply, Dispensation – Inventory Management, Accountability • Electronic Clinical Outcomes Assessments (eCOA) & Electronic Subject Reported Outcomes (ePRO) • Integration with Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), other electronic systems, etc. • Standard and custom Reporting, Notifications - alerts, Data Exports Reporting Notifications Data Exports
- 5. IVRCC’s: IVRS-IWRS Features • Extensive Clinical Study Experience, IVR/IWR custom coding, with fast deployments • PIN and passcode secured, secure hosting and advanced security protocols, SSL encrypted communication protocol and 21CFR part11 & HIPAA compliant • SaaS - No software maintenance, or programming by client • Support BYOD - No proprietary hardware investment: telephones, computers, mobile devices • Redundancy (IP, servers, facilities), tested and proven backup systems and protocols, strategically co-located carrier facilities • Scripts translated into virtually any written and spoken languages/dialects • IVRS: Large simultaneous call volume capacity, international and toll-free 24/7/365 subject access via phone, or cell phone, skype • IWRS: Scalable, access via virtually all internet connected devices - PCs/Macs, IE, Chrome, Firefox, Safari etc. browsers, with website formatting for smartphones and tablets, iOS and Android
- 7. Randomization 95% of studies include randomization • Single randomization list for entire study • Randomization list by country • Randomization list by site • Randomization stratified by location, gender, level of condition, age, etc. • Minimization techniques • Custom/Client specific algorithms • Experience with dynamic technique • Other, e.g. Sequential Parallel Comparison Design (SPCD): Blocked Randomization Stratification Dynamic Randomization Coordinate with CTM Dispensation Multiple Factors Desired Balance Assign Treatment Coordinate real-time, data exchange with EDC
- 8. CTM Management & Accountability Clinical Trial Material Management: Device/Drug
- 9. CTM Management Services Manage, track and report • Release initial supply allotments of study materials to activated sites • Multiple supply models and management at central, regional and site inventories • Project inventory needs per supply timelines and level of activity in different countries, sites • Inventory availability following shipment and treatment allocation • Dispensing and titration management, accommodating real-time parameters, investigator determinations, previous treatments and branched subject response entries, adaptive trials • On Demand Reports, real-time notifications appropriate to user categories • Reviews and actions based on Expiry dates/product recall • Continuous human intervention oversight provided by IVRCC staff • On Demand Unblinding/Emergency Code Break system for restricted users • Provide Clinical Trials Supply Management and Integration with other CTMS applications
- 10. CTM Accountability Distribution Depot to Depot Depot to site Dispensation Subject randomization and pack allocation Accountability Subject dispensing and return documentation Reconciliation Review and confirmation of accountability data Returns Management of return shipments Destruction Destruction confirmation Clinical Trial Material supply management system tracks from central to multiple regional depots to point of allocation to a subject. CTM Accountability system picks up at this point and tracks back from a subject until final resolution of CTM is completed.
- 11. ePRO Electronic Patient Reported Outcomes
- 12. ePRO and Subject Data Many Types of Information • Medication Compliance • Time/Date of events • Modality (voice/web) Preferences • Quality of Life (QoL) – Mood – Ability to perform certain physical/cognitive tasks • Self Reported Symptoms • Work and Productivity • Efficacy of CTM • Subject Satisfaction • Safety Side effects Validated Instruments and Novel Questionnaires • Numeric Scales • YES/NO Questions • Multiple Choice • Verbal Rating Scales • Visual Analog Scales (VAS) • Free text • Body Diagrams • Dynamic Branching • Rater Evaluations • ….and more
- 13. ePRO: Therapeutic Areas of Experience Asthma Allergy Attention Deficit Hyperactivity Disorder Bronchitis Constipation Depression Gastroparesis GERD HIV+ (young men) Hypertension Insomnia Irritable bowel syndrome Migraine Oncology Osteoarthritis Overactive bladder Parkinson’s disease Pneumonia Sexual dysfunction Ulcerative colitis Venous thrombosis Women’s health
- 14. ePRO: Compliance Case Studies Indication Reporting Frequency Calling Period Compliance Number of Patients Allergic Rhinitis Twice Daily 3 Weeks 88% 901 Migraine Daily 26 Weeks 95% 47 Allergic Rhinitis Twice Daily 3 Weeks 92% 862 Hormone Replacement Therapy Daily 16 Weeks 90% 1134 Von Willebrand’s Disease PRN/Once per Month 1 Year 93% 389 Pain Daily 4 Weeks 92% 365 ePRO Validation Studies Daily 2 Weeks 96% 160
- 15. ePRO: Laptop or PC or Mac
- 16. ePRO: Apple IPhone Smartphone
- 17. ePRO: Samsung Android Smartphone
- 18. ePRO: Apple IPad or Samsung Tablet
- 20. Scheduled, or on demand • Entire data- base, or partial, data, metadata • End of study final archive available for Sponsor, CRO and sites, by permission • Electronic File • Burnt to CD Reporting, Notification, Exports Real-time tracking via the web • Standard and custom designed for each study • Reporting details according to users’ assigned role-based permissions • Viewable, sortable & filterable, downloadable, printable, exportable to Excel Reports Confirmation of an event, or NON- event • Fax, text, phone call and/or email – to site, medical monitor, CRA, study manager even ePRO subjects • Occur as the result of any study event – Randomization confirmation – Supply shipment – Supply reorder – Diary reminder – Lack of diary compliance Notifications Fax and/or email • Status reporting, scheduled for run at pre-defined time intervals (daily, weekly, monthly) and sent via FAX or Email − Cumulative subject or site tracking information − Projections − Custom Reporting Batch Reports Exports
- 21. Study Snapshot Chart Site Enrollment Status Report Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 22. Study Snapshot Graphs Registrations Report Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 23. Study Snapshot Chart & Graph Subject Status - Randomization Report Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 24. Study Snapshot Chart Client Subject Status and Diary Compliance Report Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 25. Study Snapshot eMail Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007 From: IVRCC Snapshot [mailto: @ivrcc.com] Sent: Tuesday, August 20, 2013 10:05 AM To: Nancy Hudak Subject: - Study Snapshot - Week 18 of enrollment Attached is the study snapshot report for the study. Feasibility of a Using a Structured Daily Diary to Assess… Enrollment started on April 16, 2013 with target enrollment of 90 subjects in 72 weeks. At current enrollment rate of 2.00 subjects per week, it is estimated to enroll the remaining 55 subjects in 27 weeks, February 2014 At best enrollment rate of 7.00 subjects per week, it is estimated to enroll the remaining 55 subjects in 11 weeks, November 2013
- 26. Study Snapshot Enrollment Report Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007 HIV-positive Young MSM
- 27. Study Snapshot Site Summary and Diary Compliance Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 28. Subject Status Subject Status and Forecasting Graph Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 29. Registration Notification eMail Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 30. Subject Detail Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 31. Subject Diary History with Payments Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007 Diary History Modality Day Date Progress Incomp lete Section Closed Compens ation Bonus Lottery Reason for Missed Diary Web 1 05/15/13 Complete 16-May 03:12 $2.00 Web 2 05/16/13 Not Started 17-May 08:30 $0.00 Web 3 05/17/13 Complete 18-May 00:46 $2.00 3 Web 4 05/18/13 Complete 19-May 01:19 $2.00 $25.00 Web 5 05/19/13 Complete 19-May 23:48 $2.00 Web 6 05/20/13 Complete 21-May 02:32 $2.00 Web 7 05/21/13 Complete 21-May 23:40 $2.00 Web 8 05/22/13 Complete 23-May 00:57 $2.00 Web 9 05/23/13 Complete 24-May 00:05 $2.00 $5.00 Web 10 05/24/13 Complete 25-May 02:30 $2.00 Web 11 05/25/13 Complete 26-May 00:37 $3.00 Web 12 05/26/13 Complete 27-May 01:48 $3.00 Web 13 05/27/13 Complete 27-May 22:22 $3.00 Web 14 05/28/13 Complete 28-May 23:36 $3.00 Web 15 05/29/13 Complete 30-May 00:46 $3.00 $5.00 Web 16 05/30/13 Complete 30-May 23:18 $3.00 Web 17 05/31/13 Complete 01-Jun 00:46 $3.00 Web 18 06/01/13 Complete 02-Jun 01:57 $4.00 $5.00 Web 19 06/02/13 Complete 03-Jun 01:08 $4.00 Web 20 06/03/13 Complete 04-Jun 00:30 $4.00 $5.00 Web 21 06/04/13 Complete 05-Jun 00:29 $4.00 Web 22 06/05/13 Complete 05-Jun 21:27 $4.00 Web 23 06/06/13 Complete 07-Jun 00:06 $4.00 Web 24 06/07/13 Complete 07-Jun 21:46 $4.00 Web 25 06/08/13 Incomplete E 09-Jun 08:30 ($1.00) Web 26 06/09/13 Complete 10-Jun 01:03 $5.00 7 Web 27 06/10/13 Complete 11-Jun 01:34 $5.00 Web 28 06/11/13 Complete 12-Jun 02:58 $5.00 Web 29 06/12/13 Complete 12-Jun 20:10 $5.00 Web 30 06/13/13 Complete 14-Jun 00:14 $5.00 Diary History – Subject 10407
- 32. Diary Compliance Grid Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007 Close Site: All Sites Subject: Modality: (All) Modality #: (All) Subject Modality # Started 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 10401 Phone 1 04/16/2011 10401 Web 2 05/21/2011 10402 Phone 1 04/30/2011 10403 Web 1 04/30/2011 10404 Web 1 05/02/2011 10405 Web 1 05/08/2011 10405 Phone 2 06/10/2011 10406 Web 1 05/15/2011 10406 Phone 2 06/17/2011 10407 Phone 1 06/05/2011 10407 Web 2 07/08/2011 10408 Phone 1 06/05/2011 10408 Web 2 07/09/2011 10409 Phone 1 06/17/2011 10410 Web 1 06/24/2011 10411 Web 1 06/25/2011 10412 Phone 1 06/27/2011 10413 Phone 1 07/03/2011 11901 Phone 1 06/14/2011 11902 Web 1 06/17/2011 11903 Phone 1 06/18/2011 11904 Web 1 06/18/2011 11905 Phone 1 06/19/2011 11906 Web 1 06/21/2011 12201 Web 1 05/15/2011 12201 Phone 2 06/17/2011 12202 Phone 1 06/24/2013 Legend: = Completed diary = Missed diary = Premature discontinued
- 33. Daily Diary Compliance eMail Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007 Good Morning Site 4 - Philadelphia, The following subjects did not record a diary for yesterday, Sunday, July 14. Subject Mode Diary Status 10407 Web Not Started 10408 Web Not Started Regards, IVRCC Team IVR Clinical Concepts, Inc Business Office: 358 Broadway, Suite 201 Saratoga Springs, NY 12866 Office: 561-391-9686 Website: www.ivrcc.com LEGAL: This e-mail, including attachments, may include confidential and/or proprietary information, and may be used only by the person or entity to which it is addressed. If the reader of this e-mail is not the intended recipient or his or her authorized agent, the reader is hereby notified that any dissemination, distribution or copying of this e-mail is prohibited. If you have received this e-mail in error, please notify the sender by replying to this message and delete this e-mail immediately.
- 34. Cumulative Diary Compliance eMail Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007 Good Day Study Staff, This is notification of your subject's expected diary dosing calls as of June 28, 4:00 AM. Please review for action that you may need to take to remind your subjects to record their dosing information for yesterday. Subject Initials DOB Visit 2 Last Dose Date Diary Calls Made Diary Calls Expected 003-026 J-R 12-Dec-1979 09-May-2012 29-May-2012 20 50 003-063 J-G 08-Jan-1991 31-May-2012 31-May-2012 1 28 003-067 JJR 13-Jan-1986 07-Jun-2012 25-Jun-2012 18 21 003-071 GEM 27-Sep-1988 07-Jun-2012 26-Jun-2012 21 21 003-076 AJF 11-Oct-1989 07-Jun-2012 21-Jun-2012 10 21 Kind Regards, IVRCC Support IVR Clinical Concepts, Inc Business Office: 358 Broadway, Suite 201 Saratoga Springs, NY 12866 Office: 561-391- 9686 Website: www.ivrcc.com
- 35. SMS Text Reminders Standard and Customized Client Reports Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 36. Telephone Metadata Standard and Customized Client Reports Drug Dispensing by Patient and Visit: PROTOCOL #CRW1007
- 37. Customer Care
- 38. Customer Care (Help Desk) • Global staff: New York, California, Florida, Canada, Europe, South Africa, India, Russia, Israel, and Trained Partner staff as needed: (e.g., Australia) • Toll-free Phone: Helpdesk for 24/7/365 coverage International, or Country phone number as needed. – Live 8 am - 8 pm EST – 8 PM - 8 AM via smartphone with 15 min. guaranteed turn around time • Email Help Desk: 30 minutes during, or after start of next work day • Ticket system: for tracking through resolution – Prioritize issues: based upon Severity level 1 Critical (recommend phone contact), 2 High, 3 Standard • Auto reset: Password & User i.d.s (85% of issues) • Online FAQ information: standard and customized per protocols
- 39. Thank You IVRCC collected data enables better scientific conclusions because the data is valid and trustworthy to regulatory authorities, which may prove to be the difference between an approval and a request for more data IVRCC— Providing Effective and Innovative Solutions for Optimizing Clinical Trial Management