eng-full corporate profile v2 2017

Corporate Profile2017

Content

1. Profile

2. Solutions & Services

3. Roadmap

4. Customers & Alliances

5. Wrap Up

Bringing companies and their clients closely using

innovative technologies.

+ quality, real time & reliable información

Industries• Pharmaceutical

• Clinical Research

• Public Health

• Patient and medical care

• Pharmacovigilance

• Epidemiologic surveillance

Trusted Flexible

Agile

Innovative

Leadership

Mario SánchezChief Architect+9 Software Architecture ExperienceUniversidad de los Andes Assistant ProfessorMasters in Systems Engineering (CUM LAUDE). Universidad de los AndesPh.D. in Sciences, Software Languages Lab - SOFT, Vrije Universiteit Brussel.Ph.D. in Engineering, University of Los Andes.

Jose JimenoPharma Expert +10 Pharmaceutical Industry ExperienceLATAM Vaccine Clinical Research ExpertMedical Doctor. Universidad Nacional de Colombia

+ engineering

team + support +

quality + medical team

Sergio RodríguezCEO+9 Software Development ExperienceProject Management Professional (PMP)Masters in Systems Engineering (CUM LAUDE). Universidad de los AndesMBA, Darla Moore Business School, SC

Miguel HuertasBusiness Development Director+10 Telecommunications LATAM ExperienceMBA, Management. University of LouisvilleB.A.Sc. Electrical Engineering (CUM LAUDE), Engineering. University of Ottawa - Canada

Standards and Guidelines

IT Industry standards

Medical, clinical, and pharma standards21 CFR Part 11

2. Solutions

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

Let's go mobile!

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.

Video Vigilant-e

Vigilant-e Data FlowSubject

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

Video Vax E-diary - Mobile App

Mobile APPs Features

Multiple data forms

Pictures

Multiple Languages

Multiple trial

Data validation

Mobile APPs Features

On/Offline forms

Bring your own device

Alerts (subjects, sites, appointments)

Real Time monitor

Simultaneous reports

Mobile APPs Features

Authentication

Easy Navigation

Electronic Signature

Geolocation

Scalability

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

Case Study

Vax E-DiaryClinical trial: 240 subjectsphase 2 vaccine PoliovirusPlace: Republic of Panama

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)

● 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

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

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!!

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.

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

Let's report information

integra IT software

We integrate software

Cloud + WEB

Security & Follow up

Real Time Monitoring

Various daily reports + WEB + easy to use

CRFSPCS

(Patient Care System)

PFS(Patient Follow Up System)

Patient Care System

MODULES

•Patient Dashboard

•Pending activities list

•Notifications

PCS - To do listThe 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

PCS - PATIENT DASHBOARDOnce 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

● 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.

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.

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 activitiesIn the pending activities section each responsible can search its own pending activities and complete them filling the data requested by the system.

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.

Patient Follow up System

MODULES

•Scheduling and Visits management.

•Patient Call Log.

•Lab Sample Management.

•Forms Management.

•Ediary & Vigilant-e integration.

•Reports

Sta k

e ho l

ders

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

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.

Case Report Form System VIDEO (CRFS)

E-Learning

Availability 24/7

SOP Training

Content:EvaluationsVideosWorkshopsCertificates

http://training.integrait.co

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

4. Customers & Alliances

Partners

Fundación para Estudios Biomédicos

Avanzados (FEBA)

5. Wrap Up

• 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.

www.integraIT.co

WE

Contact us: Sergio Rodríguez+57 3006117931sergio.rodriguez@integrait.co

Andres Duarte+57 3166957052andres.duarte@integrait.co