First presented in CPHl Istanbul 2016. It introduces the future developments on CTMS and EDC systems for clinical trials and their effects on the research industry. Shows how technology can revolutionize the clinical research in areas like risk based monitoring, key risk indicators, machine learning and remote SDV.

1. ClinicalTrial Management Systems of next decade
Empoweringresearchwith Risk-Based monitoring
and mobileengagement
Fotis Stathopoulos
CEO, CCDM
Infoset CPhl Istanbul
4/6/2015

2. What is CTMS?
A clinical trial management system or CTMS is used in clinical research
to manage the data and progress of a clinical trial
• Data entry with EDC
• recruitment
• patient/subject scheduling & tracking;
• Validation checks
• Analysis, reporting and storage
• Monitoring support & SDV
• AE reporting and Safety
• Billing and invoicing
Administrative and clinical research needs are interrelated

3. CTMSs are going to shape the
future of clinical research by:
- Risk based approach to design (adaptive design) and
Monitoring
- Remote SDV and other resource intensive procedures
- Business intelligence & KRIs
- Machine learning & Secure Data quality
- Business process management

4. 1)Theevolution
ofHCIprinciples
(human-
computer
Interaction)
Systems will become as friendly as paper CRF.
(e-paper CRF)
 no technical training for the investigators.
 All changes are recorded and behavior will
generate data for analysis and risk
identification
Gains:
Reduce overhead to learn different systems
Run more trials
Reduced issues and discrepancies
Optimized fraud detection

5. 2)Clinicaldata
andreview onany
device
Source data capture will be available from EHRs and
other digital media
 Growing trend is to get source data directly from
health records
 Trials associated procedures are digitized (consent
forms, patient questionnaires etc.)
 Lab data and safety information can me retrieved
from health enabled devices
EDC (Electronic Data Capture) will take place on mobile
devices/ tablets or from patient home
Monitors will assess and monitor data from
everywhere
Gains:
Minimum errors
Mobility
Patient participation and engagement

6. 3) Risk based
monitoring
Risk based monitoring will become standard
Clinical protocols will incorporate risk based approach
and adaptive design
Gains:
 Resource efficiency
(20 visits to all sites is better than 3 visits x 10 sites)
 Better data quality (site and data, safety)
 Better planning, scheduling & milestones
completion
 Cost Reduction (10 to 40% travel costs, resource
cost, site time, general monitoring time)
 KPI driven by KRI
 Streamline drug development
 R&D pipeline

7. 4) Intelligent
Dashboards
(KPIs)
KPIs with machine learning: Simple or intelligent
generated KPIs that calculate factor weight with
machine learning from historical data i.e.:
 Enrollment target (total and per site)
 Queries answered and resolved
 Adverse events
 Drop out rates
 Deviation from visit dates
Gains:
 Early identification and
assessment of risks with
increased accuracy

8. 5) Key Risk
Indicators
(KRIs)
Almost all data points will be correlated to
risk. => Data Quality Oversight
Input from
• EDC,
• Monitoring,
• ePRO,
• Lab
• ECG
• safety
Entities Sites, Regions, Patients, Users
Methodology Aggregate data, Missing data
Variation between visits, Differences
among patients, Outliers, Abnormal
Events, …..
Data Points Audit trail, Queries, Protocol deviation,
Recruitment, BMI, blood pressure, Visits
interval, time to event, Creatinine and
alboumine values, Scores, Questionaires
Risks identified &
Focused SDV
Staff training issues, Atypical population,
bad performance, faulty measures,
misunderstanding of protocol procedures

9. 6) Interactive
notification &
Users
Engagement
Gamification principles will be introduced
to study participation. Patients will receive
reminders and notifications for next visits,
study progress and other information and
their benefits of participating in the trial.
More real-time data will be available
through mobile application and
interconnected medical devices.
CRAs and Investigators will be updated on
any critical or important study event, all
study workflow and communications will
be controlled from CTMS.

10. 7)
Standardization
CDISC will become standard in
database design and data transfer.
http://www.fda.gov/ForIndustry/DataStandards/StudyDataSt
andards/ucm368613.htm
FDA is planing to accept only SDTM,
ADaM and CDASH submission formats
for trial starting after 2016
http://cdisc.org/FDA-Final-Binding-Guidance-on-Standards

11. Infoset
Infoset is an innovative IT firm focusing on the clinical
research sector internationally. Based on the vast experience
of its people and strong business know-how, Infoset delivers
cloud based clinical solutions and tailor made services for
pharmaceuticals, biotechnology, medical devices and
diagnostics companies, academic institutions, contract
research organizations and other.

12. Infoset has developed i-CDMS™, a popular cloud based EDC &
CTMS:
 Ideal choice for pharmaceutical affiliates
100% ROI is achieved by the first trial running with i-CDMS®
Intelligent Risk-Based Monitoring
Mobile engagement through personalized notifications and alerts.
Built on intuitive HCI (Human Computer Interaction) principles (first
EDC with auto-save)
Quick turnover (15 days)

13.  High user friendliness and usability
95% investigators satisfaction
Affordability
30% cost reduction on the average trial compared to paper CRF.
Trial monitoring savings:
monitoring cost is 20% lower with risk based monitoring.
Keeping study under control:
Schedules and milestones are met 25% more frequently

14. Thank you
Your goals ...
… our
devotion.
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