Case Study: Sales to Trial to Marketing Life Cycle

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1 Case Study: Sales to Trial to Marketing Life Cycle Joanne White VP of Clinical Development Chitra Sundaram Assoc. Director- Enterprise Data Warehouse

2 PAREXEL International, LLC Over $1 Billion in Annual Net Revenues Over 1,200 Ongoing Trials in 25+ Therapeutic Areas Development Support for 45 of 50 Top Selling Drugs Currently on the Market Representative Customers Pharmaceutical Companies Global Biotech Emerging Biopharmaceutical All of Top 50 Top 10 Top 10 > 100 Top June 2011 ProcessWorld

3 PAREXEL Awards and Accolades June 2011 Nov July 2010 May 2010 Oct Mar Feb PAREXEL Makes Globe 100 List of Top Performing Publicly Traded Corporations in Massachusetts PAREXEL s #15 ranking is up from #49 last year in this list of the region s top 100 businesses Clinical Research Team of the Year Scrip Award PAREXEL Chairman and CEO Named Executive of the Year in North America in International Business Awards Perceptive Informatics eclinical Suite Also Named as Distinguished Honoree in the Best New Product or Service of the Year: Computer Software New Version Category Best 10 Pharma Outsourcing Company by IAOP Perceptive Informatics Named Winner in the European Outsourcing Awards Recognized for Its Truly Integrated eclinical Solution BioSingapore Award for Best Performing CRO Perceptive Informatics Receives Frost & Sullivan Product Line Strategy Award Top June 2011 ProcessWorld

4 PAREXEL Capabilities 27 June 2011 ProcessWorld

5 Product Development Continuum Pre-IND IND / CTA Phase I Phase IIa Phase IIb Phase III NDA / MAA (CTD) Peri-Approval/ Phase IV Clinical Research Perceptive Informatics PAREXEL Consulting Medical Communications Phase I-IV Project Management Site Management Patient & Investigator Recruitment Data Management Biostatistics Bioanalysis Medical Services Medical Imaging IVRS / IWRS EDC Integration Services CTMS epro Product Dev & Regulatory Affairs Strategic Compliance & Risk Management Clinical & Manufacturing Quality Process Consulting Reimbursement / Patient Assist Pgms Medical Education & Communications Meetings / Events / Exhibits Educational Services Scientific Publications RMA Process Expertise Technology Expertise Product Development Expertise Communication Expertise 27 June 2011 ProcessWorld

6 PAREXEL Office Locations PAREXEL has more than 10,350 employees worldwide Belgium Czech Republic Denmark Finland France (2) Germany (3) Hungary Italy Lithuania Netherlands Poland Romania Russia (2) Spain Ukraine (2) United Kingdom (6) United States (17) California Connecticut Illinois Maryland Massachusetts New Jersey North Carolina Pennsylvania Virginia Argentina Brazil Chile Peru Mexico Israel South Africa (3) India (2) Australia Japan (4) China (5) Hong Kong Indonesia S. Korea Malaysia Philippines Singapore Taiwan Thailand located in 71 offices throughout 52 countries. 27 June 2011 ProcessWorld

7 PAREXEL Therapeutic Experience Past 5 Years 27 June 2011 ProcessWorld

8 Concepts and Terminology Indication Therapeutic Area MEDRA Clinical Trial Management Clinical Data Management 27 June 2011 ProcessWorld

9 Business Drivers Ability to demonstrate sufficient experience in therapeutic area during RFP accurately. Unified grouping of therapeutic area impacts operational efficiency in terms of recruitment of patients. Ability to estimate time to set up sites in specific countries for a given TA leading to generation of higher revenue/ cost dollars Ability to collate experience information by therapeutic area leading to consistent filing of internal documents in our document sharing system. 27 June 2011 ProcessWorld

10 Putting the problem in Context Sales Project Mgmt Clinical Trial Mgmt Clinical Data Mgmt Operation Mgmt Key Stakeholders Sales Associates Business Development Managers Account Managers Project Managers Project leads BPS Admin Project Managers Project Leads Clinical Research Assistants Project Financial Analyst Key Process Collate information as provided in RFP Finalize financial information Site set up information Collection of patient data Reporting actual units performed Forecasting revenue and resource Data Domains Customer Opportunity Project operational data Site management data People (Investigators, nurses, doctors) Patient data Adverse Events Regulatory Reports Financial Data Operational Data Opportunities for improvement Indication information is obtained from RFP but association of Indication to Therapeutic Area is siloed Association of Indication to Therapeutic Area is siloed Association of Indication to Therapeutic Area is siloed Association of Indication to Therapeutic Area is siloed Association of Indication to Therapeutic Area is siloed 27 June 2011 ProcessWorld

11 Exercise Indication Therapeutic Area 1. Gastroesophageal Cancer a) Pediatrics 2. Bone Cancer b) Hematology and Oncology 3. Cerebral Palsy c) Gastroenterology 4. Eye Infection d) Rheumatology and Orthopedics 5. Bronchitis e) Infectious Disease 6. Thrombocytopenia f) Ophthalmology 7. Peptic Ulcer g) Neurology and Psychiatry 27 June 2011 ProcessWorld

12 Exercise Solution Indication Therapeutic Area 1. Gastroesophageal Cancer a) Pediatrics 2. Bone Cancer b) Hematology and Oncology 3. Cerebral Palsy c) Gastroenterology 4. Eye Infection d) Rheumatology and Orthopedics 5. Bronchitis e) Infectious Disease 6. Thrombocytopenia f) Ophthalmology 7. Peptic Ulcer g) Neurology and Psychiatry 27 June 2011 ProcessWorld

13 Project Mgmt System Experience Database Sales System EDW Clinical Data Mgmt System Clinical Trial Mgmt System Master Data Management 27 June 2011 ProcessWorld

14 Root Cause of the Challenge Weak ownership of data. No master source for indications and therapeutic areas Inconsistent definition of key data Little cross-functional collaboration. Lack of integration of systems resulting in re-entry of information in multiple systems. 27 June 2011 ProcessWorld

15 Solution People Identified SMEs as Data Stewards for identification and hierarchy management of indications. Process Established a data governance committee Established a MDM for Indication and Therapeutic area and maintaining it as a Single source of Truth Lookup of new indications refer to the MEDRA code list as needed. Established workflow chains for approval of new hierarchies. Accepting multi-level, multi-parent TA hierarchy Expanded data sharing Technology Implementation of Therapeutic Area hierarchy in OneData MDM. Phased integration of consumers to one source of data- single source of truth 27 June 2011 ProcessWorld

16 OneData MDM 27 June 2011 ProcessWorld

17 OneData MDM 27 June 2011 ProcessWorld

18 OneData MDM 27 June 2011 ProcessWorld

19 OneData MDM 27 June 2011 ProcessWorld

20 Results Early phases of integration At completion, will provide 360 o view of Therapeutic Area and indication accepting this as a Enterprise Asset. Ability to demonstrate experience in the Therapeutic Area of interest during RFP with better quality data. Enablement of business intelligence and analytics, such as Average time to set up sites by countries by Therapeutic Area Average number of patients in a Therapeutic Area Revenue by Therapeutic Area to determine strategies for new wins Probability of finding investigators by Therapeutic Areas 27 June 2011 ProcessWorld

21 Key Takeaway High Quality, single source of master data enables deep business insights and powers business intelligence 27 June 2011 ProcessWorld

22 Contacts-

23 Thank you!

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