Sanjay Sahoo, MedImmune, presents The Role of a Business or Systems Analyst in the Clinical / Medical / Regulatory Space at the February 23, 2012 IIBA Pharma/Biotech Special Interest Group Webinar.

1. IIBA® Pharma/Biotech SIG
Monthly Webinar
The Role of a
Business or
 Cover this area with a Systems Analyst
picture related to your in
presentation. It can
be humorous. Clinical/Medical/
Regulatory
 Make sure you look at
the Notes Pages for
more information 23 Feb 2012
about how to use the
template. Sanjay Sahoo,
MedImmune
© International Institute of Business Analysis

2. IIBA® Pharma/Biotech SIG
Monthly Webinar
The Role of a
Business or
 Cover this area with a Systems Analyst
picture related to your in
presentation. It can
be humorous. Clinical/Medical/
Regulatory
 Make sure you look at
the Notes Pages for
more information 23 Feb 2012
about how to use the
template. Sanjay Sahoo,
MedImmune
© International Institute of Business Analysis

3. Agenda
• Welcome & Announcements
• The Role of a Business or Systems Analyst in
Clinical/Medical/Regulatory
 Sanjay Sahoo, MedImmune
• Q&A
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4. Welcome
• Speakers
 Sanjay Sahoo, MedImmune
• IIBA Pharma/Biotech SIG Staff
 Host – Michael Calluori (Sanofi), VP of the Community
 Question Moderator – Carol Scalice (Pfizer), President
 Webinar Administrator – Matt St. Louis (Pfizer), VP of Marketing
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5. Join the Community
• Starting April 2012
 Closed webinars (not public)
 Must be an IIBA® member
• Join the Community
 http://community.iiba.org/pharmabiotechsig
 No additional cost
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6. Certification Credit
• PDUs/CDUs for SIG Events
 1 webinar = 1 CDU
 Recertification only
* As per IIBA® Certification team *
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7. Volunteer
• Open Interim Board Positions
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 VP of Event Planning
• Filled Interim Board Positions
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Services
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8. Who to Contact
Please contact one of the acting board members listed below:
Carol Scalice: President
Carol.Scalice@pfizer.com
Mike Horn: VP, Membership
michael.horn@astrazeneca.com
Matthew St. Louis: VP, Marketing
matthew.v.st.louis@pfizer.com
Michael Calluori: VP, Community
Michael.Calluori@sanofi-aventis.com
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9. Next Webinar
• “What about ...? What I wished I had asked the
regulatory and testing people.”
 Griffin Jones, Congruent Compliance
 Monday, March 19th, 12-1p
 Register Today
 https://www2.gotomeeting.com/register/823957186
• Call for Speakers
 Send us your topic ideas and submissions today!
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10. The Role of the BA or Systems Analyst in
Clinical/Medical/Regulatory
• Speaker
 Sanjay Sahoo
 Business Analyst, MedImmune
• Q&A
 “Raise Hand”
 Chat Window
© International Institute of Business Analysis

11. The Role of a Business/System Analyst in Clinical/
Learning Objectives:
I. Basic understanding of BA/SA role
II. Is there a boundary for BA/SA role by industry?
III. How pharma/bio-tech BA/SA roles differentiate from
other industry?
IV. Does BA/SA require any special skill sets?
V. Does prior experience in pharma/bio-tech matters?
VI. Understand birds eye view of clinical drug
development process
VII. How clinical/medical/regulatory systems are aligned
with the process?
VIII. What are the industry standards?
IX. How to be informed about pharma/bio-tech
industry?
X. What are next steps for BA/SA role in pharma/bio-tech
industry?

12. About Me
Sanjay Kumar is a Senior Business/System Analyst at MedImmune
LLC. (A subsidiary of AstraZeneca PLC)., where he plays a role of Sr.
IS/IT Specialist of the Clinical/Medical/Regulatory domain. Prior to
joining to MedImmune, he had an extensive experience with Health
Informatics Technology (HIT) which includes
implementation, design, business analysis, systems analysis and IT
strategy planning for US Government agencies such as National
Institute of Health, National Cancer Institutes, Division of Aids (NIAID)
and Pharmaceutical/Bio-Tech companies. Overall Mr. Sanjay has 15
years of experience in the bio-informatics field providing enterprise
solutions for pharma/bio-tech industry. He had a recent success
implementing e-Clinical program at MedImmune LLC. He has a strong
educational background, includes Bachelors of Science in
Physics, Master of Science in Computer Science, and Master in
Business Administration from Johns Hopkins University, USA.”
© International Institute of Business Analysis

13. Business/System Analysis Role
• Works in the context of an organization
• Understand Business People Process
• Understand Business Processes BA/SA
Role
• Determine process improvement
• Define the business/functional requirements
• Understand IT eco Systems Technology
• Implement by assisting Technical Team
Business/System Analyst role is the techniques used to work as a liaison among
organization stakeholders in order to understand
people, processes, technology, regulations, policies, and work instructions for
operations of an organization, and propose best approaches or solutions that
enable organizations to achieve organizational goals
© International Institute of Business Analysis

14. Industry Boundary?
Answer is NO…
Business/Systems analyst position for healthcare domain, there are lot
of expectations from the business/systems analyst candidate.
Healthcare domain is a complex domain and requires a good working
background in the industry to know in detail its business process and
internal workings.
© International Institute of Business Analysis

15. How BA/SA role differentiate?
General BA/SA Role Clinical/Medical/Regulatory BA/SA
• Gather Requirement • Performs all as described in
• Perform Systems Analysis General BA/SA role PLUS below
• Manage Team i.e. technical, • Work with Doctors, RN, Scientists,
creative, and production, Lab Technician
external vendor and contractors • Understand GXP includes GCP
• Scope the requirement guidelines
• Align to the budget • Understand Frequent Changes in
Regulatory Agencies Rules
• Direct development lifecycle
from inception to completion • Required a depth knowledge on
Health Informatics - Mandatory
• Assist Programming team
• Attend Conferences, Training
• Use best practice ensuring frequently
consistency and stability
• Need to have people skills
• Develop wireframe or demo
application for concept • Negotiation and Agreements
© International Institute of Business Analysis

16. Special Skill Sets Required
• Requirement Methodologies
• Testing Methods – Regression, Unit Test, Blackbox
• Software Development Framework - SDLC
• Clinical Trial procedures and terminology
• Knowledge in tools like SAS, eCTMS, EDC, IVRS, Safety
System
• Knowledge of GXP Assessment
• Regulatory Agencies Guidelines
• Knowledge of 21CFR Part 11
• Industry Standards like ICH, MedDRA, CTC, CDISC,
BRIDGE, HL7, LOINC
• XML with eSubmission processes
© International Institute of Business Analysis

17. Prior Experience Required?
• Both “Yes” and “No”
• If “Yes” – easier to adapt to the
environment quickly
• Else required extensive training
• Both cases you need to be open to
adapt the complex world
© International Institute of Business Analysis

18. Clinical Drug Development Process
File IND/CTA File BLA/NDA/sNDA
With FDA With FDA
Phase II Phase III
Drug Discovery Pre-Clinical Phase 0 Phase I ~100-500 Human 1000 and more Phase IV
~5000-10000 Compounds Animal Trial ~10-15 ~20-100 Trial 1 Compound Human Trial Post Marketing
~250 Compounds Human Trial Human Trial ~5 Compounds) 1 Compound
R&D Space Clinical Development Space Pharmacovigilance Space
~ 14 years in total to market
NDA – New Drug Application
BLA – Biologic License Agreement
IND – Investigational New Drug Application
IDE – Investigational Device Exception
sNDA – Supplemental New Drug Application
Safety
CTA – Clinical Trial Authorization File in EU
Quality
Efficacy
Disclaimer – The use of images in this presentation are abstracted from www.google.com. The purpose of these images are ONLY for learning/academic. This is NOT for any
commercial or marketing use.
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19. List of Systems for Clinical Space
CLINICAL REGULATORY MEDICAL
Clinical Forecasting System Central Document Management Information Request Management
Clinical Project Planning eSubmission Planning & Tracking Information Request Content
Management
Protocol Authoring Tool Commitment Tracking
Reprint Tracking
Clinical Trial Management System Submission Publishing
Compliance Reporting Management
Electronic Data Capture Product Registration Management
ePublication Management
Interactive Voice Recognition Tool Correspondence Tracking
Grant Management
Paper Based Trial Product Complaints Tracking
Investigator Initiated Trial Mgmt
Statistical Programming (SAS) eCTD Reviewer
Key Opinion Leader Management
Electronic Trial Master File Business Event Tracking
Medical Library Management
Clinical Trial Transparency Product Detail Management Mobile Request Management
Patient Safety System Scientific Communication Tracking
Safety
Drug Supply Management
Central Medical Coding System
Quality
Investigator Management Tool
Efficacy
eClinical Data Hub
Central Study Designer
© International Institute of Business Analysis

20. Industry Standards
Standards
Regulations Guidelines Referencing Dictionaries
Messaging Coding Metadata
21CFR 11 (Audit) ICH E2A (Efficacy Guidelines) CDISC (Clinical Data Standard) MedDRA (Med Coding ISO/IEC 11179 (Information HL7 + HL7 CVX (vaccine form)
Technology - Metadata registries
(MDR)
45 CFR164 (Security) ICH E2B (Data Transfer) LOINC (Lab Code) WHO-ART (Rational Coding AE) LOINC (Lab Code)
HIPAA (Patient Info) ICH E2BM (Clinical Safety Data DICOM (Digital Imaging and WHO Drug NDF-RT (National Drug File
Management) Comm) Reference Terminology)
Section 508 (Disability) ICH E5 (Ethnic Factors in the HL7 (Health Level 7) SNOMED-CT Systemized EVS (NCI Enterprise Vocabulary
Acceptability of Foreign Clinical Nomenclature of Medicine - Clinical Services)
Data) Term)
FDAAA (Trial Transparency) ICH E6 (GCP) NDC (National Drug Code) OMB Directive 15 (Race and Ethnic
Standard)
eCTD (Electronic Submission)
EudraCT ICH M1 (MedDRA MSSO) ISO 639 (Language)
CTC AE (Common Toxicity Criteria
Adverse Event)
ICH M2 (MedDRA eCTD Spec) ISO 3166 (Code name for
Countries)
© International Institute of Business Analysis

21. How to be informed?
• Be part of IIBA Pharma/Biotech SIG
www.iiba.org
• Enroll to DIA www.diahome.org
• Subscribe clinical trial magazines
• Be a member of HIMSS group
www.himss.org
• The best way to have friends from
health industry
© International Institute of Business Analysis

22. Next Step for a BA/SA role
• Project Lead
• Project Manager
• Subject Matter Expert
• Process Engineer
• Process Architect
• Enterprise Process Engineer
• Business Manager
• System Director
• Health Informatics Technology Consultant
© International Institute of Business Analysis

23. Q/A
Thank you
If you have any question, please contact me at
sanjay05m@gmail.com
© International Institute of Business Analysis

24. Thank you for attending!
• Next Webinar
 “What about ...? What I wished I had asked the regulatory and
testing people.” - Griffin Jones, Congruent Compliance
 Monday, March 19th, 12-1p
 Register: https://www2.gotomeeting.com/register/823957186
• Contact the President: Carol.Scalice@pfizer.com
 Topic ideas and speaker submissions
 Volunteering – Communications, Event Planning
 Joining the Community
© International Institute of Business Analysis