A knowledge based collaborative model for the rapid integration of platforms, people and processes.
Upcoming SlideShare
Loading in...5
×
 

A knowledge based collaborative model for the rapid integration of platforms, people and processes.

on

  • 804 views

Presentation given at DIA EDM meeting in Washington DC in February 2010.

Presentation given at DIA EDM meeting in Washington DC in February 2010.
Presentation introduces the notions of BPM and BI for the life sciences industry.

Statistics

Views

Total Views
804
Views on SlideShare
792
Embed Views
12

Actions

Likes
0
Downloads
29
Comments
0

3 Embeds 12

http://www.linkedin.com 8
http://www.slideshare.net 2
https://www.linkedin.com 2

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment
  • Process Engine – a robust platform for modeling and executing process-based applications, including business rulesBusiness Analytics — enable managers to identify business issues, trends, and opportunities with reports and dashboards and react accordinglyContent Management — provides a system for storing and securing electronic documents, images, and other filesCollaboration Tools — remove intra- and interdepartmental communication barriers through discussion forums, dynamic workspaces, and message boards

A knowledge based collaborative model for the rapid integration of platforms, people and processes. A knowledge based collaborative model for the rapid integration of platforms, people and processes. Presentation Transcript

  • A knowledge based collaborative model for the rapid integration of platforms, people and processes.
    Feb 19th 2010
    Paul Fenton
    Montrium Inc.
  • The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
     
    These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
    2
    www.diahome.org
    Drug Information Association
  • Introduction
  • How we work today
    Information and procedural silos
    In today’sGxPlandscapewe have:
    Many individuals, groups and organizations working independently
    Many computerized systems working independently
    Many different department or organization specific processes
    All generate data and information which for the most part remains dislocated and underexploited
    This makesourworkingenvironment inefficient and costly
  • Lack of operational knowledge
    In a silo based model, it is difficult to gain cross system, cross functional knowledge
    We spend a lot of time transcribing, reconciling and collating data
    Often we do not have a clear picture of study progress at any one point in time, even less across programs of studies
    We do not fully exploit operational data (generated from automated system processes) and transform it into knowledge
  • The Challenge
    In todays R&D environment, our challenge is to:
    Makebetterdrugdevelopmentdecisions
    Accelerate time to market
    Increase organizational efficiencies and agility
    Improve understanding and management of R&D processes
    Reduce cost
    Reduce risk
    Improve quality
    Improvecompliance
  • Meeting the Challenge..
    To meet the challenge we must break down organizational and procedural silos by:
    Leveraging new technologies and work methods
    Map out, re-engineer, automate and integrate processes
    Leverage and establish procedural and data standards
    Integrate computerized systems and data sources
    Identify clear and measurable metrics and KPIs
    Align and integrate the quality system withautomatedprocesses
    BPM and BI can help!
  • Definition of BPM
    Business process management (BPM) is a management approach focused on aligning all aspects of an organization
    It is a holistic management approach that promotes business effectiveness and efficiency while striving for innovation, flexibility, and integration with technology
    Is based on continuous improvement of processes
    Source: Wikipedia
  • BPM technology elements
  • Definition of Business Intelligence
    In 1958 Hans Peter Luhn, a computer scientist at IBM used the term business intelligence for the first time. He defined intelligence as: "the ability to apprehend the interrelationships of presented facts in such a way as to guide action towards a desired goal."
  • Definition of BI
    BI refers to skills, processes, technologies, applications and practices used to support decision making
    BI technologies provide historical, current, and predictive views of business operations
    BI is composed on reports, dashboards, metrics and analytical models
    BI is capable of transforming operational and business data into information and knowledge
  • BI Implementation
    Top Critical Success Factors are:
    Business driven methodology & project management
    Clear vision & planning
    Committed management support & sponsorship
    Data management & quality issues
    Mapping the solutions to the user requirements
    Performance considerations of the BI system
    Robust & extensible framework
    Source: Naveen K Vodapalli, 2009
  • Mapping out processes – High level to detailed
    We typically think of clinical trial organization as hierarchical
    Processes usually align to a particular level of hierarchy
    Processes can be high level and then drill down
  • Process Maps
    Molecule
    Development
    Bio-
    Equivalence
    Discovery
    PROGRAM
    IND
    Phase I
    Launch
    NDA
    Phase II
    Phase III
    Pre-Clinical
    Studies
    API/DP
    eCTD
    Submission
    Regulatory
    Approval
    Publishing
    MOLECULE
    STUDY
    Site
    Selection
    Monitoring
    Plan
    Protocol
    Development
    ICF
    Development
    eCRF
    Development
    SITE
    CDA
    SQV
    SIV
    CTM
    Ship.
    CTA
  • Identifying milestones and KPI
    Milestones are predefinedeventswithin a process or processes
    Milestones are calculated or non-calculated values based on one or many datapoints
    Milestones correspond to predefinedkeyevents or values within the variouslevels of the processmaps
    Examples of Milestoneswouldbe:
    IND Submission (MoleculeLevel)
    Protocol Approval (StudyLevel)
    FPFV (Site Level)
  • Identifying milestones and KPIs with process maps
    KPIs are keyoperationalindicatorswhich are calculatedusing information fromprocesses, data and documents
    KPIs are calculated or non-calculated values based on one or many datapoints
    KPIscanbedrilled in to toseeunderlyingKPIs and data or rolled-up to seehigherlevelKPIs
    Examples of KPIswouldbe:
    Time between FPFV and DB Lock (studylevel)
    Time between last query and DB lock (studylevel)
    Time to queryresolution (study, site level)
    Number of queries by status (study / site)
    Averageprotocol IRB approval time (site)
  • Identifying milestones and KPIs with process maps
    MOL101 – IND Preparation
    Time = 4mths
    IND
    Started
    eCTD
    Submission
    Document
    Authoring
    eCTD
    Compilation
    Time to FPFV
    = 6mths
    Document
    Publishing
    Document
    Review & Approval
    Phase I
    Initiation
    FPFV
    Time to FPFV
    = 1mth
    CDA
    SQV
    SIV
    CTM
    Ship.
    CTA
    IRB
    Approval
    FP
    Screened
    FP FV
  • Identify data sources and integration points
    Data sources for KPIs and Milestonescan come from:
    Documents and document metadata
    Procedures and procedural data (workflows)
    Databases (EDC, CTMS, Safety etc.)
    Project plans and manualmetrics
    Whenthinking about data for KPIs and Milestones, itis important to identify unique data sources
    Establishment and use of standards iskey to be able to integrate data sources and procedures
  • IntegratingProcessesthrough BPM
  • Building an operational knowledge model
    Dashboards -
    roll-up, drill-down, drill-in
    By identifyingkeymetrics, milestones and indicatorsat all levelswe are able to develop multi-dimensionaldashboards
    Thesedashboardsallow up to move up and down in ouroperationalknowledge
    By adding a third dimension we are able to drill in both in terms of data but also time
    This model enables us to pin point keyfactorswhich have positive/negative impacts on ouroperations
  • Aligning with the QMS
    Implementingthisapproachoftenrequires changes to components of the QMS
    Whenre-engineering processestry and break them down intoclearsteps, tasks, responsabilities and delvierableelements
    Clearlyidentify all interconnections on processmaps
    Re-engineermanualprocessesintoautomatedprocesses
    Finallyaligntheseelements to your BPM and collaborative environment
  • Recommended approach
    Map out R&D processmaps; rememberhigh to low
    Identifyprocesses (SOPs) and interactions for eachlevel and step
    Identify people and organizationswhointervene in eachprocess and step
    Identify data sources
    Identifykeymetrics, milestones and KPIs
    Identifytechnologyelements
    Define a scope for pilot project
    Implement and improve
  • The light is at the end of the tunnel
    Drug Information Association
    www.diahome.org
    23