Here is our corporate profile, you will find information about all our solutions for vaccines clinical trials and also patient's programs. We have a variety of mobile and web apps that have been developed to enhance and improve your results in any clinical trial or patient care system.

1. Corporate
Profile
2017

2. Content
1. Profile
2. Solutions & Services
3. Roadmap
4. Customers & Alliances
5. Wrap Up

3. Bringing companies and
their clients closely using
innovative technologies.
+ quality, real time &
reliable información

4. Industries
• Pharmaceutical
• Clinical Research
• Public Health
• Patient and medical care
• Pharmacovigilance
• Epidemiologic surveillance

5. Trusted
Flexible
Agile
Innovative

6. Leadership
Mario Sánchez
Chief Architect
+9 Software Architecture Experience
Universidad de los Andes Assistant Professor
Masters in Systems Engineering (CUM LAUDE). Universidad de los Andes
Ph.D. in Sciences, Software Languages Lab - SOFT, Vrije Universiteit
Brussel.
Ph.D. in Engineering, University of Los Andes.
Jose Jimeno
Pharma Expert
+10 Pharmaceutical Industry Experience
LATAM Vaccine Clinical Research Expert
Medical Doctor. Universidad Nacional de Colombia
+
engineering
team +
support +
quality +
medical team
Sergio Rodríguez
CEO
+9 Software Development Experience
Project Management Professional (PMP)
Masters in Systems Engineering (CUM LAUDE).
Universidad de los Andes
MBA, Darla Moore Business School, SC
Miguel Huertas
Business Development Director
+10 Telecommunications LATAM Experience
MBA, Management. University of Louisville
B.A.Sc. Electrical Engineering (CUM LAUDE), Engineering. University of
Ottawa - Canada

7. Standards and Guidelines
IT Industry
standards
Medical,
clinical, and
pharma
standards21 CFR Part 11

8. 2. Solutions

9. Our Solutions
Mobile APPs WEB Platforms
• Vax CRFs
• PCS (Patient Care System)
• PFS (Patient Follow-up
System)
• Vax E-Diary
• Vigilant-e
• ICP-Mobile
• VaxChat

10. Let's go mobile!

11. Vax E-Diary & Vigilant-e
Our mobile solutions automates data
collection in epidemiological studies and
clinical trials, giving an accurate and timely
system to follow up subjects.
We use state of the art technology, which
provide precise, instant and unique
information that can be access using our
web access.
We use secure and precise data bases, in
addition to all the necessary IT support for
your projects.

12. Video Vigilant-e

13. Vigilant-e Data Flow
Subject
Coordinator
Health
personnel
● Symptom
reminders
● Visit reminders
● Report & Data
Reminders
● Call log
● Schedule visit
management
● Subjects monitoring
○ Data Pending
○ Fever/Symptoms
● Adverse Events management.
● Subject information consultation

14. Video Vax E-diary - Mobile App

15. Mobile APPs Features
Multiple data forms
Pictures
Multiple Languages
Multiple trial
Data validation

16. Mobile APPs Features
On/Offline forms
Bring your own device
Alerts(subjects, sites, appointments)
Real Time monitor
Simultaneous reports

17. Mobile APPs Features
Authentication
Easy Navigation
Electronic Signature
Geolocation
Scalability

18. Mobile APPs Usage
Available for Android devices or
feature phone using SMS (Vigilant-e)
Intuitive and easy to use
APP
e-Training available
Help & Navigation menu
Phone contacts possibilities

19. Case Study
Vax E-Diary
Clinical trial: 240 subjects
phase 2 vaccine Poliovirus
Place: Republic of Panama

20. 89%Percentage of records
received with the VAX E-
Diary application out of
the maximum number of
records we could have
received. (including drop
out subjects)
Compliance Rate (ITT)

21. ● 68% of all records were
available in less than 30
seconds.
● 84% of all records were
available in less than 1
hour
● Paper diaries were not
available in average, until
27 days after they were
completed.
Opportunity

22. 75% of the users had previously used a smartphone.
50% of the users had android cellphones. 25% had a phone that is
not a smartphone and 19% didn’t have a cellphone.
62% think the e-diary app is very easy to use and 37% think it’s
easy; Totalling 99%.
85% of the people never had any issues with the e-diary.
79% of the users prefer the e-diary over the paper diary.
93% of the user would recommend the e-diary for further studies.
Survey

23. Efficiency
● The average time needed to pass all of the visits paper diary
records regarding one patient to the eCRF was 60min.
● This means that in this study a total of 5,644 hours
were spent to transcript the paper diary to the CRF.
● By using the VAX E-diary there are significant savings in
resources, time and money!!

24. Contemporaneous
data and accuracy
99.6% of all the records had a correct completion
start and finish timestamp, making us able to verify that
records were completed and sent as expected.
100% of the records had accurate timestamps in the
CRF allowing a clear audit trail if needed.

25. According to a study published in the British Medical
Journal, “Although 90% of subjects reported completing
the paper diary on time, only 11% actually completed it
as instructed. They were able to track paper diary entries
by embedding photo sensors into the diary binder”
(BMJ2002;324:0.6)
Paper diary real
compliance
http://www.assistek.net/whats_new/wp-content/uploads/2012/10
/Patient-Noncompliance-with-Subject-Diaries_BMJ_20021.pdf

26. Let's report information

27. integra IT software
We integrate software
Cloud + WEB
Security & Follow up
Real Time Monitoring
Various daily reports + WEB + easy to use
CRFS
PCS
(Patient Care System)
PFS
(Patient Follow Up System)

28. Patient Care System
MODULES
•Patient Dashboard
•Pending activities list
•Notifications

30. PCS - To do list
The To Do list is the first step on our PCS, there, our customers can plot and define in a
clear way all the processes and all the necessary activities in order to complete each
process
On the other hand, our PCS is a kind of BPM that allows configuring any activities flow
where:
● The user completes the activities according to the defined flow.
● patients’ states and novelties.
● Follow the configured flows for each defined process without skipping any process or
activity

31. PCS - PATIENT DASHBOARD
Once the process and activities are defined in the To do list, a patient dashboard is
generated which aims to improve patient’s access through the use of technology and
process improvement. the patients dashboard has 3 main sections.
The first one are filters where users can filtered the information by:
● Patient state
● Pathology
● EPS
● City

32. ● Assigned processes
information are shown along
with the patient’s information
in each process.
Statistics section
● Patients states are shown,
and categorized based on
color coding.
● Patient’s responsibles are
shown as well as the states
of the patients assigned to
them
On the second section you will find statistics related to the patient’s state which allows to have
an overview of patient states, processes summary and activity responsibles.

33. Past due activities list
The third section is the past due activities list where the
user can find the most important information about
activities like:
● Past due days
● Responsible
● Activity name.

34. Once activities are completed alerts will be
generated and the patient's state will be updated,
which can be easily identified with the activities color
coding.
Pending activities
In the pending activities section each responsible can search its own pending activities and
complete them filling the data requested by the system.

35. Notifications
● The notification module will appear once each user starts a session on the PCS, there
you will find the most relevant messages from the patients assign to each user.

36. Patient Follow up System
MODULES
•Scheduling and Visits management.
•Patient Call Log.
•Lab Sample Management.
•Forms Management.
•Ediary & Vigilant-e integration.
•Reports

38. CRFS
• Multiple clinical trials or sites management.
•Security according to industry standards.
•Data trails and time stamps.
•High available systems.
•Reports generator and customization.
•Change control.
•Integration to Mobile APP
Specialized
Software

39. CRFs - Characteristics
“Electronic Case Report”: input and
monitoring of information within a clinical
trial.
• Subject enrollment.
• Data input from paper forms.
• Queries management (Discrepancies).
• Data validation final review by
investigator.
• Single subject reports and visualization.

40. Case Report Form System VIDEO (CRFS)

41. E-Learning
Availability 24/7
SOP Training
Content:
Evaluations
Videos
Workshops
Certificates
http://training.integrait.co

42. 3. Roadmap
2017 Q4 -
Medical
electronic
records
2017 Q2 –
Electronic
informed
consent
2018 Q1 -
Surveillance Apps
massification
• Solutions constellation.
• Seeking the best possible opportunities to
improve information quality and adherence
programs.
• Application SUITE for data management.
2017 Q1 – iOS
version
2017 Q3-
Vaccines trials
planning and
allocation tool

43. 4. Customers & Alliances
Partners
Fundación para
Estudios Biomédicos
Avanzados (FEBA)

44. 5. Wrap Up

45. • We integra IT technology bringing users
and customer closely.
• We are flexible and agile.
• Unique and innovative solutions.
• We want to be your IT partner.
• We think different (we can!)
• We believe that Data Quality &
Opportunity is a MUST in clinical trials.

46. www.integraIT.co
WE
Contact us:
Sergio Rodríguez
+57 3006117931
sergio.rodriguez@integrait.co
Andres Duarte
+57 3166957052
andres.duarte@integrait.co