VAX E-Diary is a mobile solution that uses mobile technology to automate clinical trial data collection and subject monitoring in real time. It provides features like authentication, digital signatures, geolocation and offline data collection. The document describes VAX E-Diary's product features, functionality, example projects using it including a 240 subject polio vaccine trial in Panama, and its data flow and security measures which are designed according to health and pharmaceutical guidance.

2. VAX E-Diary
mobile solution
2016

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

4. Content
1. Product Features
2. Functionality
3. Projects
4. Data Flow & Security

5. VAX E-Diary is always with you

6. 1. Product Features

7. Our solution VAX E-Diary uses mobile
technology in order to automate data
collection and subject monitoring in
clinical trials.
We provide real time data with unique
timely information for the trials, as well as
a WEB portal to manage more efficiently
site's resources.
We use state of the art technology, which
provide precise, instant and unique
information.
VAX E-Diary

8. Authentication
Traceability
Digital Signature
Geolocation
Scalability
VAX E-Diary Features

9. VAX E-Diary Features
Multiple data forms
Pictures/Audios/Videos
Navigation
Multiple trial
Data validation

10. On/Offline forms
Bring your own device
Alerts(subjects, sites, appointments)
Real Time monitor
Scheduling
VAX E-Diary Features

11. VAX E-Diary
Clinical Trial: 240 subjects
Polio
Place: Republic of Panama
87%
Percentage of records received with the
VAX E-Diary application out of the
maximum number of records we could
have received. (including dropout subjects)
Compliance Rate (ITT)

12. 2. Functionality

13. VAX E-Diary Functionality APP (Video)

14. 3. Projects

15. ● Polio Vaccine Clinical Trial
● Start Date: Nov 1, 2013.
● 240 Subjects using VaxE-
Diary in Panama City.
● Planned Duration: 1 Year
PANAMÁ IPV 005

16. PANAMÁ, LITHUANIA &
DOMINICAN REPUBLIC
Polio Vaccine Clinical Trial
● 100 Subjects using VaxE-Diary in
Lithuania.
● Start Date: January 7, 2016.
● 164 Subjects using VaxE-Diary in
Panama City.
● Start Date: October 23, 2015.
● 154 Subjects using VaxE-Diary in
Dominican Republic.
● Start Date: November 30, 2015.

17. 4. Data Flow & Security

18. 1. Training
We train your team in our
App VaxE-Diary
Our training site is powered
by Moodle. Here you will
find videos, workshops and
tests.
Through
Once your team complete the
training courses, they will
graduate.
Aim
Your team is now capable to
manage the system and train
the participant subjects.
Continue to installation
and Ediary Completion
http://training.integrait.co

19. 2. Installation and Ediary Completion
Depending on the Sponsor
requirements, each Subject has two
options in order to get the VaxE-
diary App
1
2
Use their own smartphone to
download the App VaxE-diary.
In case that the subject does not
have a smartphone, Integra It can
provide smartphones for the
studies.
The subject reports on a daily
basis his/her symptoms on the
VaxE-diary App.
The App sends notifications the
subject for missing reports.
Continue to information
management

20. 3. Information Management
When a ediary report is completed
on the App, then the information is
shown on our web platform PFS,
where your team can see all the
data.
Our system has two types of alerts
The team have to contact the
subjects and make a request about
the missing information or a high
intensity symptom.
1. If there is missing information
about subjects symptoms.
2. If any subject presents a high
intensity symptom.
Continue to reports and
Data Export

21. 4. Reports and Data Export
During the study. We can create
tailor made reports or export all the
information of your project
You will decide how do you
want to have all the project
data.
We are available to export the
data in the format that you
required.

22. IT Industry
Standards
Health,
research and
Pharma
guidance21 CFR Part 11
Vax-Ediary Security
information security guidance

23. •End to end design using the IT
and clinical top guidance for data
security.
•Information audit trail.
•High reliable systems within the
application and the data base.
•Data validation and authentication
VAX E-Diary
Security

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