A knowledge based collaborative model for the rapid integration of platforms, people and processes.
Signaler
Partager
•0 j'aime•519 vues
![A knowledge based collaborative model for the rapid integration of platforms, people and processes.,[object Object],Feb 19th 2010,[object Object],Paul Fenton,[object Object],Montrium Inc.,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-1-2048.jpg?cb=1670183510)
![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. ,[object Object], ,[object Object], 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. ,[object Object],2,[object Object],www.diahome.org,[object Object],Drug Information Association,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-2-2048.jpg?cb=1670183510)
![Introduction,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-3-2048.jpg?cb=1670183510)
![How we work today,[object Object],Information and procedural silos,[object Object],In today’sGxPlandscapewe have: ,[object Object],Many individuals, groups and organizations working independently,[object Object],Many computerized systems working independently,[object Object],Many different department or organization specific processes,[object Object],All generate data and information which for the most part remains dislocated and underexploited ,[object Object],This makesourworkingenvironment inefficient and costly,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-4-2048.jpg?cb=1670183510)
![Lack of operational knowledge,[object Object],In a silo based model, it is difficult to gain cross system, cross functional knowledge,[object Object],We spend a lot of time transcribing, reconciling and collating data ,[object Object],Often we do not have a clear picture of study progress at any one point in time, even less across programs of studies,[object Object],We do not fully exploit operational data (generated from automated system processes) and transform it into knowledge,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-5-2048.jpg?cb=1670183510)
![The Challenge,[object Object],In todays R&D environment, our challenge is to:,[object Object],Makebetterdrugdevelopmentdecisions,[object Object],Accelerate time to market,[object Object],Increase organizational efficiencies and agility,[object Object],Improve understanding and management of R&D processes,[object Object],Reduce cost,[object Object],Reduce risk,[object Object],Improve quality,[object Object],Improvecompliance,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-6-2048.jpg?cb=1670183510)
![Meeting the Challenge..,[object Object],To meet the challenge we must break down organizational and procedural silos by:,[object Object],Leveraging new technologies and work methods,[object Object],Map out, re-engineer, automate and integrate processes,[object Object],Leverage and establish procedural and data standards,[object Object],Integrate computerized systems and data sources,[object Object],Identify clear and measurable metrics and KPIs,[object Object],Align and integrate the quality system withautomatedprocesses,[object Object],BPM and BI can help!,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-7-2048.jpg?cb=1670183510)
![Definition of BPM,[object Object],Business process management (BPM) is a management approach focused on aligning all aspects of an organization,[object Object],It is a holistic management approach that promotes business effectiveness and efficiency while striving for innovation, flexibility, and integration with technology,[object Object],Is based on continuous improvement of processes,[object Object],Source: Wikipedia,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-8-2048.jpg?cb=1670183510)
![BPM technology elements,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-9-2048.jpg?cb=1670183510)
![Definition of Business Intelligence,[object Object],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.",[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-10-2048.jpg?cb=1670183510)
![Definition of BI,[object Object],BI refers to skills, processes, technologies, applications and practices used to support decision making,[object Object],BI technologies provide historical, current, and predictive views of business operations,[object Object],BI is composed on reports, dashboards, metrics and analytical models,[object Object],BI is capable of transforming operational and business data into information and knowledge,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-11-2048.jpg?cb=1670183510)
![BI Implementation,[object Object],Top Critical Success Factors are:,[object Object],Business driven methodology & project management,[object Object],Clear vision & planning,[object Object],Committed management support & sponsorship,[object Object],Data management & quality issues,[object Object],Mapping the solutions to the user requirements,[object Object],Performance considerations of the BI system,[object Object],Robust & extensible framework ,[object Object],Source: Naveen K Vodapalli, 2009 ,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-12-2048.jpg?cb=1670183510)
![Mapping out processes – High level to detailed,[object Object],We typically think of clinical trial organization as hierarchical,[object Object], Processes usually align to a particular level of hierarchy,[object Object],Processes can be high level and then drill down,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-13-2048.jpg?cb=1670183510)
![Process Maps,[object Object],Molecule ,[object Object],Development,[object Object],Bio-,[object Object],Equivalence,[object Object],Discovery,[object Object],PROGRAM,[object Object],IND,[object Object],Phase I,[object Object],Launch,[object Object],NDA,[object Object],Phase II,[object Object],Phase III,[object Object],Pre-Clinical,[object Object],Studies,[object Object],API/DP,[object Object],eCTD,[object Object],Submission,[object Object],Regulatory,[object Object],Approval,[object Object],Publishing,[object Object],MOLECULE,[object Object],STUDY,[object Object],Site ,[object Object],Selection,[object Object],Monitoring,[object Object],Plan,[object Object],Protocol ,[object Object],Development,[object Object],ICF ,[object Object],Development,[object Object],eCRF,[object Object],Development,[object Object],SITE,[object Object],CDA,[object Object],SQV,[object Object],SIV,[object Object],CTM,[object Object],Ship.,[object Object],CTA,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-14-2048.jpg?cb=1670183510)
![Identifying milestones and KPI,[object Object],Milestones are predefinedeventswithin a process or processes,[object Object],Milestones are calculated or non-calculated values based on one or many datapoints,[object Object],Milestones correspond to predefinedkeyevents or values within the variouslevels of the processmaps,[object Object],Examples of Milestoneswouldbe:,[object Object],IND Submission (MoleculeLevel),[object Object],Protocol Approval (StudyLevel),[object Object],FPFV (Site Level),[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-15-2048.jpg?cb=1670183510)
![Identifying milestones and KPIs with process maps,[object Object],KPIs are keyoperationalindicatorswhich are calculatedusing information fromprocesses, data and documents,[object Object],KPIs are calculated or non-calculated values based on one or many datapoints,[object Object],KPIscanbedrilled in to toseeunderlyingKPIs and data or rolled-up to seehigherlevelKPIs,[object Object],Examples of KPIswouldbe:,[object Object],Time between FPFV and DB Lock (studylevel),[object Object],Time between last query and DB lock (studylevel),[object Object],Time to queryresolution (study, site level),[object Object],Number of queries by status (study / site) ,[object Object],Averageprotocol IRB approval time (site),[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-16-2048.jpg?cb=1670183510)
![Identifying milestones and KPIs with process maps,[object Object],MOL101 – IND Preparation ,[object Object],Time = 4mths,[object Object],IND,[object Object],Started,[object Object],eCTD,[object Object],Submission,[object Object],Document,[object Object],Authoring,[object Object],eCTD,[object Object],Compilation,[object Object],Time to FPFV ,[object Object],= 6mths,[object Object],Document ,[object Object],Publishing,[object Object],Document,[object Object],Review & Approval,[object Object],Phase I ,[object Object],Initiation,[object Object],FPFV,[object Object],Time to FPFV ,[object Object],= 1mth,[object Object],CDA,[object Object],SQV,[object Object],SIV,[object Object],CTM,[object Object],Ship.,[object Object],CTA,[object Object],IRB,[object Object],Approval,[object Object],FP ,[object Object],Screened,[object Object],FP FV,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-17-2048.jpg?cb=1670183510)
![Identify data sources and integration points,[object Object],Data sources for KPIs and Milestonescan come from:,[object Object],Documents and document metadata,[object Object],Procedures and procedural data (workflows),[object Object],Databases (EDC, CTMS, Safety etc.),[object Object],Project plans and manualmetrics,[object Object],Whenthinking about data for KPIs and Milestones, itis important to identify unique data sources,[object Object],Establishment and use of standards iskey to be able to integrate data sources and procedures,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-18-2048.jpg?cb=1670183510)
![IntegratingProcessesthrough BPM,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-19-2048.jpg?cb=1670183510)
![Building an operational knowledge model,[object Object],Dashboards - ,[object Object],roll-up, drill-down, drill-in,[object Object],By identifyingkeymetrics, milestones and indicatorsat all levelswe are able to develop multi-dimensionaldashboards,[object Object],Thesedashboardsallow up to move up and down in ouroperationalknowledge,[object Object],By adding a third dimension we are able to drill in both in terms of data but also time,[object Object],This model enables us to pin point keyfactorswhich have positive/negative impacts on ouroperations,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-20-2048.jpg?cb=1670183510)
![Aligning with the QMS,[object Object],Implementingthisapproachoftenrequires changes to components of the QMS,[object Object],Whenre-engineering processestry and break them down intoclearsteps, tasks, responsabilities and delvierableelements,[object Object],Clearlyidentify all interconnections on processmaps,[object Object],Re-engineermanualprocessesintoautomatedprocesses,[object Object],Finallyaligntheseelements to your BPM and collaborative environment,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-21-2048.jpg?cb=1670183510)
![Recommended approach,[object Object],Map out R&D processmaps; rememberhigh to low,[object Object],Identifyprocesses (SOPs) and interactions for eachlevel and step,[object Object],Identify people and organizationswhointervene in eachprocess and step,[object Object],Identify data sources,[object Object],Identifykeymetrics, milestones and KPIs,[object Object],Identifytechnologyelements,[object Object],Define a scope for pilot project,[object Object],Implement and improve,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-22-2048.jpg?cb=1670183510)
![The light is at the end of the tunnel,[object Object],Drug Information Association,[object Object],www.diahome.org,[object Object],23,[object Object]](https://image.slidesharecdn.com/diaedmfinal-12709074108798-phpapp01/75/a-knowledge-based-collaborative-model-for-the-rapid-integration-of-platforms-people-and-processes-23-2048.jpg?cb=1670183510)
A knowledge based collaborative model for the rapid integration of platforms, people and processes.
•0 j'aime•519 vues
Signaler
Partager
Télécharger pour lire hors ligne
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.
Contenu connexe
Tendances
Tendances(20)
En vedette
En vedette(6)
Similaire à A knowledge based collaborative model for the rapid integration of platforms, people and processes.
Similaire à A knowledge based collaborative model for the rapid integration of platforms, people and processes.(20)
A knowledge based collaborative model for the rapid integration of platforms, people and processes.
Notes de l'éditeur
- 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