Case Study: Sales to Trial to
Marketing Life Cycle
Joanne White
VP of Clinical Development
Chitra Sundaram
Assoc. Director- Enterprise
Data Warehouse
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
Top 10
Representative Customers Pharmaceutical Companies Pharmaceutical Companies All ofTop 50
Top 10
Global Biotech Global Biotech Top 10 Emerging Biopharmaceutical Emerging Biopharmaceutical > 100
PAREXEL Awards and Accolades
Top 10
June 2011 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 Nov. 2010 Clinical Research Team of the Year Scrip Award
July 2010 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
May 2010 Best 10 Pharma Outsourcing Company by IAOP
Oct. 2009 Perceptive Informatics Named Winner in the European Outsourcing Awards Recognized for Its Truly Integrated eClinical Solution
Mar. 2009 BioSingapore Award for Best Performing CRO
Product Development Continuum
IND / CTA Pre-IND Phase I Phase IIb Phase III Peri-Approval/ Phase IV Phase IIaNDA / MAA (CTD)
Phase I-IV
Project Management Site Management
Patient & Investigator Recruitment Data Management Biostatistics Bioanalysis Medical Services Process Expertise Medical Imaging
IVRS / IWRS
EDC Integration Services CTMS ePro Technology Expertise Product Dev
& Regulatory Affairs
Strategic Compliance & Risk Management
Clinical & Manufacturing
Quality Process Consulting
Reimbursement / Patient Assist Pgms
RMA
Product Development Expertise
Medical Education & Communications
Meetings / Events / Exhibits
Educational Services
Scientific Publications
Communication Expertise
PAREXEL Office Locations
PAREXEL has more than 10,350 employees worldwide
located in 71 offices throughout 52 countries.
Mexico
Japan (4)
India (2)
Australia Ukraine (2) United Kingdom (6)
South Africa (3) Israel United States (17)
California Connecticut Illinois Maryland Massachusetts New Jersey North Carolina Pennsylvania Virginia China (5) Hong Kong Indonesia S. Korea Malaysia Philippines Singapore Taiwan Thailand Belgium Czech Republic Denmark Finland France (2) Germany (3) Hungary Italy Lithuania Netherlands Poland Romania Russia (2) Spain Argentina Brazil Chile Peru
PAREXEL Therapeutic Experience
Past 5 Years
Concepts and Terminology
Indication
Therapeutic Area
MEDRA
Clinical Trial Management
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.
Putting the problem in Context
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 Clinical Data Mgmt Operation Mgmt Clinical Trial Mgmt Project Mgmt Sales
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
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
EDW
Clinical Trial
Mgmt System
Sales System
Project Mgmt
System
Experience
Database
Clinical Data
Mgmt System
Master Data
Management
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
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.
Results
Early phases of integration
At completion, will provide 360o 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
