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 [email protected]
Andres Duarte+57 [email protected]