2. Contents
• About Us
• Objective Of the Tool
• About the Project
• Collection Methods & Analytical Tools
• The Subtleties Between EMEA Offices
• Building The Calculator
• Using the Calculator
• Support Assets
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3. Confidential Co. Core PV Specialties
Long Global History With JnJ & Janssen
Site Optimization
Social Network AE
Monitoring and Resource Planning
Reporting
Integrated Alliance Process
Management (iAM) Automation
BPO Capabilities
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4. Typical Pharmacovigilance Process
Review
Commercia
l Status
Amended
Spontaneous
Social Rx Info
Reports
Networks & Licensing
Literature Partners
Submissio
Reports n
Clinical Data
Trial Data Review
Product
Complaints
& LOE Licensing Inquiry Worldwide
Partners & Respons Regulatory
Signal
Alliances e Reports
Detectio
n
INTAKE COLLATE
& &
COLLECTION TRANSLAT ANALYZE COMMUNICATE
E
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5. Objective Of The Tool
To help Drug Safety and Surveillance executives
plan and manage optimized staffing levels
especially during surge events and other crisis
situations.
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7. Client Enablers
1 2 3 4 5
Provide client Enable client
with an to accurately Client has the Client has the
analysis of predict surge ability to print ability to Provide
their current staffing levels colorized utilize rapid knowledge
processes, and at a budgeted, reports for “Rule of transfer and
a modeling utilized and immediate Thumb” transparency
tool for optimized insertion into calculations of solution to
“What-If” and level as well as executive-level outside of the the client.
“2B” the change in presentations. tool.
scenarios. FTE required.
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8. Challenges
Overcoming the natural protective barriers put forth by
internal staff whenever efficiency projects are commenced
Gaining a firm understanding of the EMEA business model
and various process flows
Documenting comprehensive multi-tier (and inter-related)
paper-based workflow processes
Coding the calculator based on client input and diverse
business environments
Slight language barriers were easily overcome
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9. Typical Top-Line Solution Steps
1. Provide initial data collection tools including forms and templates
2. Perform staff interviews, time studies and volume assessments
3. Document start to end case process flow pre-optimization
4. Perform identification, organization and documentation of the SIPOC
(Sources, Inputs, Processes, Outputs and Customers)
5. Analyze activities, data and document findings
6. Organize data into work streams and determine direct vs. indirect time
for any FTE processing cases
7. Build the Resource Calculator
8. Test and confirm output. Run against the simulation tool to “tune” the
calculator
9. Provide “Rule of Thumb” and polynomial prediction formula’s for rapid
Volume/FTE calculation without tool
10. Perform walkthrough of the simulator results and operation of the
calculator with client staff
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19. Analysis Of Indirect Time Differences
Process Indirect Work
• 12 Unique Categories
– Serbia 8
– NEWAAT 2
– Germany 1
– Ukraine 1
– Time Range 0.1 hr to 4.0 hrs. PV Agreements And Inefficient Office Setup Accounted For The Largest Indirect Time
• Consistent Categories Value Ranges
Audit N, S
Time Range
Compliance Check N, S, U
Low 0.05 hr Serbia - SPC Checks
Inefficient Office Setup N, S
High 8.0 hr Serbia - PV Agreements
Literature Search & Reviews S, U
Other Projects N, S, U
Next Top 3
PV Agreements N, S 7.5 hrs NEWAAT - Other Projects Ad Hoc
Queries N, S 5.0 hrs NEWAAT - Other Projects NPP, Clin Trials
Reconciliations N, S, U 4.0 hrs NEWAAT - Inefficient Office
Reporting - Other N, S, U 4.0 hrs NEWAAT - PV Agreements
SOP Review & Management G, N, S
Note: Hours per Week
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20. Analysis Of Indirect Time Differences
People-Related Indirect Work
• 100% Same Categories
• Consistent Categories Value Ranges
Meetings G, N, S
Time Range
Recruiting - HR G, S
Low 0.2 hr Germany – HR-Related
Training - Self S, U
High 3.5 hr NEWAAT Training Self
Training - Others S, U
Training - Both G, N
Next Top 2
3.0 hrs NEWAAT - Meetings
1.5 hrs Ukraine – Training Both
Although all offices had training for self & others, Germany and NEWAAT combined them.
Only Germany and Serbia engage in HR - Recruiting type activities.
Note: Hours per Week
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21. Analysis Of Indirect Time Differences
Technology Indirect Work
• 100% Same Categories
• Consistent Categories Value Ranges
Non-IT Related S, U
Time Range
IT-Related G, N, S, U
Low 0.1 hr Germany – Technology Breakdown
High 1.0 hr Serbia – Non-IT Issues (Fax/Printer Difficulties)
Next Top 3
0.7 hrs NEWAAT – SRS System Delays & Breakdowns
0.5 hrs Ukraine – Non-IT Fax
0.5 hrs Serbia – IT Issues
All offices experience Technology Issues. Only Serbia and
Ukraine listed Non-IT issues as significant.
Note: Hours per Week
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25. Output Area Of The Tool
Budgeted FTE Utilized FTE Optimized FTE Required FTE ∆ in FTE
• Actual "real and • Budgeted FTE • Takes the • Reflects the FTE • Number of FTE
current" FTE with average utilized FTE and needed to that should be
based on your standard optimizes it process the increased (+) or
office's standard additional hours based on work entered volume decreased (-)
workweek and (OT) worked. distribution and with zero idle over
work hours per max efficiency time or Max comparator.
day. (87.5%) in Capacity.
current
operating
environment.
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26. Screen Shot Of Calculator Main Screen
Single View Example
EMEA Multi-View Capability
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29. Resource Calculator Overview
Tabbed Sections
The Resource Calculator Main Page
Consists Of Several Sections
• Monthly Volume Input Section With
Default Values
• Budgeted FTE Input Section With Default
Values
• Daily Case Volume Processed By FTE Input
Sections
• Output Comparison Table
• Output Graphic “At-A-Glance” Indicators
Each Section Contains “At-A-Glance”
Indicators
• Color-coded Entry Points Match Graphical
Indicators On The Dashboard
• Percentage Breakouts
• Volume And Status Indicators
• Additional Section Calculations
• Percent Change Calculations
Other Contents
• Benchmark Comparative Values
• Rules Of Thumb For Predictive “On-The-Fly”
Calculations Using either the linear formula or
Dead Reckoning with the graph
• Output Definitions
Office Selector – For Ease of Navigation
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