Is Your Safety Inbox a Black Hole?

Is Your Safety Inbox a Black Hole?July 9, 2015

Presenter:Brad GallienVP, Product DevelopmentNovember Research Group

2NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

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Safe Harbor

SummaryA quick look into the presentation

NOVEMBERRESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions

• About November Research Group• Collection of Adverse Events• Challenges• Business Impact• PRIMO Overview• Demo• Wrap-Up


About November Research Group• November Research Group (NRG) provides global drug safety system

implementation services and software solutions for pharmaceutical and life science organizations– 70 consultants specializing in Oracle Argus, Oracle AERS, Empirica Trace– Experts in product safety regulations and pharmacovigilance systems– Global projects in the US, Europe and Japan– Dedicated Japanese practice area

• What we do?– Argus Safety implementation– Software tools such as PRIMO– AERS support– Complex data migration projects– EQMS, BPM projects– Custom reporting– Business Transformation

Who are our partners?GoldPartner

SpecializedOracle Argus Safety


Our Capabilities

Services Software Evaluation

& Vendor Management

PV Process Optimization

Platform Upgrade/ Implementation

Migration Training Validation Support

Products PRIMO Platform

Family PRIMO

Manufacturer PRIMO Regulatory PRIMO MR iPRIMO Reporting Tool:

WebReports E2B Viewer

Incorporating lessons learned from previous projects

Strong knowledge of global requirements: U.S., EU & Japan

Experts in Argus implementations

PMP certified project managers

Risk based approach mitigating compliance risk

Successful track record for extending the capabilities of commercial-off-the-shelf (COTS)

safety systems

20+ years of product development experience in Life Sciences

Senior management experience in safety software development

Robust system development lifecycle

Maintenance includes enhancements &updates

English/Japanese speaking senior consultants drive project deliverables & communication transparency

Validation best practices compliant with CFR Part 11, EMA and PMDA regulations

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PRIMO Family Matrix OverviewRegulatory 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

• Tight integration with Global PV system

• Capture full MR data entry footprint (fields) for potential adverse event

• PV-MR follow-up correspondence

• Send secure email or E2B to PV team

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


Collection of Adverse Events

Adverse events are collected from multiple sources including:• Spontaneous• Literature• Social Media• Partners• Sales representatives• Clinical Trials

Typically, adverse events are forwarded to a company’s Safety Group Inbox. This can lead to many challenges posing risks to the safety profile of products.


Challenges

Lost Emails

Data QualityIssues

Manual Communication

Disconnected workflow

Limited Audit Controls


How Does This Impact Your Business Process?

PV departments struggle with intake and find themselves spinning their wheels to address challenges.


PRIMO

High-Level Workflow – PRIMO Overlay

Sources

Intake Review

Triage

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3

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① Emails directly pulled and stored in PRIMO

② Automated letter generation and follow-up tracking

③ Full lifecycle of correspondence tracked

④ Report exchange with external systems

⑤ Fully audited and compliant process

All sources of potential AEs

Commercials systems such as Oracle Argus, ARISg, Sparta Trackwise or Pilgrim

PV/EQMS


PRIMO Benefits

Features BenefitsLight-weight and easy to use Decrease data entry errors

Support all intake streams Instant metricsManagement of complete intake lifecycle Improved efficiency with a single intake solution

Correspondence Management Decrease follow-up response time

PV System integration Process ICSRs faster and boost your customers’ reporting timeliness

PRIMO is designed to make your intake process more transparent and more compliant


This product demonstration is only available for webinar live attendees.

If you’d like to see a demo, please contact us:• Brad Gallien – VP, Product Development

[email protected](415)279-9107

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

Product Demonstration


Questions?

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


• Visit our website http://www.novemberresearch.com/

• Download PRIMO Datasheethttp://www.novemberresearch.com/files/PRIMODataSheetEnglish.pdf

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

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

Next Steps

http://www.novemberresearch.com/

http://www.novemberresearch.com/files/PRIMODataSheetEnglish.pdf

Is Your Safety Inbox a Black Hole?

Technology

Transcript of Is Your Safety Inbox a Black Hole?