2006 PDMA Sharing Conference

Transcription

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2 2006 PDMA Sharing Conference Mission Impossible: Implementing an Electronic PDMA System, Without Losing Your Mind Jeff Cantor, CollaGenex Pharmaceuticals Don Schenker, Synergistix

3 How did we get to this point? A Little History

4 Paper!!!! The PDMA Requires significant storage and immediate access to sample data Submission time speeds up Filings, Paperflow increase Amount of paper produced increases

5 Answer Technology?

6 Many of you seem to think it is Vast majority of pharma companies doing some or all of the job electronically Most of those that aren t, are seriously considering it In past presentations, this session focused on Paper processing and electronic processing

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8 Why Electronic?

9 Why Electronic? The law lends itself to electronic solutions Aids in sample reconciliation activities Kill less trees Click more mice Make reps more efficient in less time Let the rep do something other than Accountability work Reduces amount of paperwork required and replaces it with Electronic work The agency has hinted as much in public forums If only it was that easy

10 Why Electronic? Speed and Facilitation of Data Access Access to information quick and easy Aids the sales reps in planning routes and maintaining measurable goals Immediate* access to call and sample data * Requires reps to transmit data on a timely basis

11 Why Electronic? Improve Accuracy and Efficiency Control over Distribution Lot Numbers Enforcement of Sampling Work Flow Rules Invalid practitioners Min/Max Sample Drops Prescriber Validation Rep Lock Outs for activities outside SOPs Reduce Administration Time for Reps Less Redundancy Less Paperwork

12 Why Electronic? Improve Compliance Prohibit sampling to Invalid practitioners Lock data after signature is captured Closed Inventory/Lot Number Systems Manage Adjustments/Returns Lot Number Control (Recalls/Expiration) Interim Physical Inventories Reduction in missing data/illegible errors Use of time-stamps

13 Why Electronic? Improve Compliance Track adherence to corporate SOPs Transmission Frequency Physical Inventory Windows Order allocations and Windows Identify potential variances Interim Reconciliation Reports Daily Register ( Check-Book ) Unmatched or unacknowledged shipments Unmatched transfers

14 Why Electronic? Improve Compliance Alerts Lack of disbursement activity Disbursement to a non valid practitioner Excessive sampling Excessive use of Sample Forms Trending Excessive adjustments Cumulative Non-significant variances Constant Perfect score (too good to be true?)

15 Why Electronic? Electronic provides data for other purposes The data collected during sampling activities typically contain the most accurate doctor and call information The data captured during sampling activities may be used for strategizing sales and marketing operations

16 Why Electronic? Utilization by other departments Senior Management Reports Market Share (rolled-up to Sales Force/Regional) Territory Inactivity (vacancies) District/Region Effectiveness Sample Disbursement (units and dollarized) Targeting Data vs. Sales Computer Command and Control Reports Transmission Review System Utilization Asset Management Suspect Activities Company Policy Adherence

17 Why Electronic? Utilization by other departments Compliance Documentation Reports Sales Rep Effectiveness Suspect Activities Training Logs Random Audits Transmission Review and System Utilization Exception and Trending Reports

18 Why Electronic? Save Money? Entire paper workflow eliminated Or maybe just reduced? Reduce printing cost Reduce mailing cost Improved SA department efficiency yields higher productivity Improved rep productivity yields more calls

19 Paper/Hybrid Systems Have Challenges Increased Cost Paper needs people Printing Costs Scanning Costs Duplicate work for Sales Representatives Increased Delays Mail Delivery is Slow Discoveries take longer Investigations take longer Easier to Manipulate

20 Electronic Systems also have Challenges Management Concerns Excessive initial and on-going costs Lack of flexibility to add doctors, change alignments, update competitive data What if the reps don t transmit in a timely fashion? Representative Concerns Possible rep down time Data may not be secure, and may get lost Change management Big Brother End of day activities for reps are too complicated or take too long

21 Let s Face it Companies have been through their first electronic system implementation Or second, or third, or fourth Many companies want to take advantage of efficiencies Many have had bad experiences with existing electronic and hybrid systems There is room for alternative opinions

22 2006 PDMA Sharing Conference Just How Much May it Save us Anyway? A Case Study

23 A Case Study Case Study Details will be handed out at the presentation

24 2006 PDMA Sharing Conference OK- The financials seem to make sense- why is this Mission Impossible? Beware of the implementation!

25 What is there to be scared of? Planning Create the Internal Team Set Time Frames Budget Vendor Selection Contracts Pre-Implementation Configuration Data Load/Conversion SOPs Validation and Testing Training

26 Planning - Create the Internal Team Establish a cross functional Project Team Make sure other departments are involved Regulatory Requirements Synergy with Sales/Marketing Information Technology Requirements Senior Management Requirements Financial Constraints Establish decision-making team VP Sales VP Legal VP Regulatory VP Finance

27 Planning - Create the Internal Team Find a Project Sponsor/Champion!!!

28 Planning - Set your Preliminary Time Frames Establish Internal and External Milestones Requirements Complete RFP Date Vendor Selection Contracts Completed Project Kick-Off Configuration Complete Validation Complete Pilot Start Pilot End Rollout Complete

29 Planning - Set your Budget Determine your ROI Cost Reduction Improved Efficiency Expandability Improved Compliance Better Information Higher Customer Service Determine your PRELIMINARY budget Management Approval Board Approval

30 Planning - Analyze Your Needs / Vendor Determine Your Requirements Receive System Demonstrations Document User/Business Requirements First Step in Validation (you need it anyway) You need it to write an RFP Make requirements SMART Specific - Measurable - Achievable - Realistic - Timely Rank Requirements Must Have, Important, Nice to Have Identify Bells and Whistles Nice to Have That which is unnecessary, complicated, or not needed

31 Planning - Analyze Your Needs / Vendor Identify Systems with Best Fit Create/Issue RFP Establish Short List of vendors Presentation to project team Map System Features/Functionality to Requirements Determine Technology Fit / Integration Evaluate company s values and culture Determine cost / value Vendor Culture Customer Focus Flexible Can-Do Attitude Group comes to a consensus Send to executive group for blessing Get your champion out front

32 Planning - Reassess Your Timeframe and Budget Does the Vendor concur: Predetermined Timeframe Predetermined Budget If not Get more time / budget Reduce the scope Reassess vendor / system decision Make the decision to go/no go

33 Planning - Contracts Bring legal group in early Require contract template as part of RFP Use internal template, if available Include/Reference specifications from RFP Capabilities included in base system Service levels and reporting Timelines Include penalties (or bonuses) where appropriate

34 Pre-Implementation Configuration Configure the system with your system goals and requirements in mind Unnecessary Bells and Whistles will add cost and increase risk Listen to your management, field managers and other departments Keep track of concessions made and features slated for future enhancements Use the system to simplify processes, when possible

35 Pre-Implementation Coordinating Data Integration Know what data is available, from where, and when the data is updated Bring in your IT group as early as possible Determine what data you want your sales force to update Benchmark the time required to implement changes in the data (products, strengths, etc.)

36 Pre-Implementation - SOPs Review your SOPs for changes in business processes Keep SOPs basic, to avoid deviations as processes change/improve Coordinate Internal SOPs with Vendor, when possible (and include in SLAs, if possible)

37 Pre-Implementation Validation and Testing Make sure the necessary documentation is in place Clearly define the validation process If sampling is included, make sure that the PDMA rules and regulations are met Include tests of the back-end to check for data integrity, back-ups, security and Disaster Recovery Plan (DRP) Use the Vendor for system testing, but a 3 rd party or internal department for validation execution

38 Pilot Include field management in the process prior to pilot Select a cross section of sales reps Allow sufficient time for feedback and to implement suggestions made by pilot team Schedule constant communication with pilot team Have a special help-desk dedicated to the pilot team

39 Training KISS - Clearly define your training goals and focus on core system functions first Employ use of hands on exercises and role plays, using real world scenarios Get Sales Training Involved Sometimes great Sales Trainers are not great Computer/Compliance trainers Measure comprehension and retention Utilize both vendor and company resources during the training Pilot Users make good facilitators/trainers

40 The Secret to Success Plan the Work and Work the Plan Create Critical Milestones and Tasks Review the Plan Update the Plan Things never stay the same Breakdown barriers as soon as possible

41 Danger Signs Communication problems between you and the vendor Starting the Blame Game Discord between internal staff and vendor Project Workplan No project workplan in place Not keeping to the project timeline Constant changes in priorities and scope Exceeding implementation budget

42 Danger Signs (continued) Excessive failures during validation testing Lack of technical documentation Missed or moved milestone dates Unmatched technology for the company requirements

43 Are You Ready to Give it a Try? A real-life scenario

44 Give it a Try Each group has been given a packet. The packet contains: Overview of our sample company, with the goals and objectives of implementing a new system Details on the current cost for sample accountability and data management services Details on the expected cost of implementing and on-going costs of an electronic system Sample RFP

45 Give it a Try Your Job: Complete the ROI worksheet at the back of the packet Complete the RFP by marking each requirement as Required, Nice to Have, Not Needed Complete the project plan with the dates, based on the assumptions included on the last page

46 Give it a Try Debrief: What was the 3 year cost/savings vs. the baseline year How much of the system/costs were unnecessary? Will you complete the implementation on time?

47 Final Thoughts

48 Final Thoughts Manage the scope of the implementation Project Management 101 Time, Cost, Quality Time Keep your timeframe in mind and be realistic about what you can implement Cost Bells and whistles cost extra Quality Focus on essential functionality Stay the course Work within your company s philosophy and goals for the system Simplicity will minimize the learning curve and increase overall effectiveness of the training

49 Final Thoughts Be open to possible changes in business processes Seek out and use field input Add advanced features (i.e. , e-training) after the initial rollout Constant communication with vendor throughout the process Use vendor in the launch process Validate the system by a 3 rd party

50 Special Thanks to Fujitsu for the use of their notebooks at the 2006 PDMA Sharing Conference