Using PRIMO Mobile to Collect Adverse Events in the Field

Using PRIMO Mobile to Collect Adverse Events in the Field"Mobilize" Your Adverse Event Intake Process

Presenter:Brad GallienVP, Product DevelopmentNovember Research Group

2NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

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SummaryA quick look into the presentation

NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

- Introduction to November Research Group

- Introduction to PRIMO

– Product Family

- PRIMO Mobile Overview

- Product Demonstration

- Q&A

4NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

• November Research Group (NRG) provides global product safety system implementation services and software solutions for pharmaceutical and life science organizations– 2003 founded, focused exclusively on medical-product vigilance solutions

– 75 + consultants and developers specializing in Oracle Argus, Oracle AERS, Empirica Trace and PRIMO

– Experts in medical product safety regulations and vigilance systems

– Oracle Gold Partner, Argus Specialized

– Global projects in the US, Europe and Japan

– Dedicated Japanese practice area

• What we do?– Argus Safety implementation/support

– Software tools such as PRIMO, WebReports, E2B Viewer

– Mobile Applications

– Big Data solutions for product vigilance

– Business Transformation

– Complex data migration projects

– EQMS, BPM projects

About November Research Group

Who are our partners?Gold

Partner

Specialized

Oracle Argus Safety

5NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

PRIMO Family Matrix Overview

Regulatory Market Manufacturer Market

PRIMO 3.0 PRIMO 2.1 PRIMO Mobile

Audience Global Regulatory bodies such as the US FDA, MHLW, EMA, TGA, etc.

PV team Sales/Field Representatives (and PV team)

Overview • Intake regulatory submissions from manufacturers and consumers (MedWatch, E2B, etc.)

• Quickly and efficiently review inbound data for public health impact

• Comprehensive correspondence management

• Query and analyze data for trends or other issues

• Central Intake system to facilitates the timely acquisition of safety information from all sources such as tweets, faxes and emails

• Comprehensive correspondence management for intake and follow-up

• Decision: promote to Global PV system or take No Action

• Tight integration with Global PV system

• Capture company-specific data entry footprint (fields) for potential adverse event

• PV-Field Rep follow-up correspondence

• Send secure email or E2B to PV team

Technology • Apache Flex/Oracle • Apache Flex/Oracle • HTML5/MySQL

6NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

• It is ubiquitous – mobile professionals are mobile enabled: smart phones and tablets

• It is expected – business applications, particularly mission critical applications, need mobile extensions

• Immediacy improves compliance

• And just to keep our regulations in mind:

For example: 21 CRF Part 803.3(c) Manufacturers are considered to have "become aware" of an MDR reportable event when:

– any employee becomes aware of a reportable event required to be reported within 30 days, or required to be reported within 5 days pursuant to a written request from FDA; or

– any employee who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable event, from any information, including any trend analysis, necessitates remedial action to prevent an unreasonable risk of substantial harm to public health.

Why mobile?

7NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

• Intake of initial adverse events discovered in the field

• Management of correspondence with reporters

• Submission of follow-up information

• Pro-active notification of pending follow-up (for example, CRA site visits)

• AE reporting history to support detailing (physician sentiment)

• Risk management alerting

Mobile PV use cases

8NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

• Intake of initial adverse events discovered in the field

• Management of correspondence with reporters

• Submission of follow-up information

• Pro-active notification of pending follow-up (for example, CRA site visits)

• AE reporting history to support detailing (physician sentiment)

• Risk management alerting

Our focus

9NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

Typical scenario

1. Visit client and discuss issue

2. HCP mentions adverse event

3. Pull out note pad, take notes

4. Return to hotel

5. Login to corporate web page

6. Click on link to report adverse event

7. Download and Print AE Form

8. Transcribe notes to AE Form

9. Scan PDF form

10. Email to PV team (or fax it)

11. Hope you got it right!

Our approach: Keep it simple

Mobile Solution

1. Visit client and discuss issue

2. HCP mentions adverse event

3. Pull out iPad, enter details

4. Press Send

5. Know you got it right!

10NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

Our solution: PRIMO Mobile

11NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

Initial AE Report

PRIMO MR Cloud- User registration

- Company’s products, studies,

doctors’ data

- Audited

Argus

PerceivePV Group

Email Inbox

FieldRep

E2B file

PV team

12NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

Messaging and Follow-up

FieldRep

PV team

Message is within PRIMO

MobileFully Audited

13NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

• The following is a simulated demonstration using screen shots and PowerPoint animation

• If you like what you see, give us a call and we’ll arrange a live demo for you and your team!

Brad Gallien – VP, Product [email protected]; (415) 279-9107

Seth Warhaftig – [email protected]; (415) 987-3313

Product Demonstration

14NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

• Multi-platform solution for mobile intake of adverse events

• Multi-tenant, available on premise or as a SaaS solution

• Fully configurable: capture the fields you want

• Fully localized: each tenant has a default language plus unlimited other languages

• Light, fast, simple, compliant

• Available now!

Summary: PRIMO Mobile is…

15NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

Questions?

Please submit your questions using the Q&A feature in the WebEx panel

16NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

• Visit PRIMO Mobile webpage http://www.novemberresearch.com/PRIMO-Mobile.php

• Download PRIMO Mobile solution overview, datasheet, infographichttp://www.slideshare.net/NovemberResearchGroup

• Brad Gallien – VP, Product [email protected]

(415) 279-9107

• Seth Warhaftig – [email protected](415) 987-3313

Next Steps