MedImmune

PM050 Delivery Work Package Template

Template Version Number: 2.1

DP1 to cover Justify

Document Details
Project Title:

BMS PV Integration

Document Status /
Version:

DP1 0.1

Project Reference
Code:

XXX

Customer Business
Area:

Patient Safety

Project Phase:

DWP created at DP1

for Justify

Primary Project
Manager:

Delivery Organisation
Project Manager:

Karthick Sukumaran

Project Sponsor:

Prepared by:

Robert Sanchez

Date Raised:

Expiry Date:

Target Start Date (this

phase):

14- Apr-2014

Target Completion
Date (this phase):

30-May-2014

Document Pre-Approval
Area

Name & Role

Approval

Financial

Yes

Commercial

Yes

Resources

Yes

Project Methodology

Yes

Integrated Assurance

Yes

Architecture

Yes

Run

Yes

Date

Disclaimer
If you are reading a copy of this document (i.e. print out of controlled electronic document or an
electronic copy of a wet ink signed paper document) you may be reading an uncontrolled version.
Before making updates, please ensure that you are using the latest version.

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Version Control
Version

Date

Description of Changes

Author

1.0

22-May-2014

Initial version

Gopi Govindarajan

1.1

28-May-2014

Updated as per WPL

Ritika Jain

Referenced Documents
Name

Version

Location

Data Migration Approach

1.0

LDMS_XXX_XXXXXX

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1. Summary
1.1

Context and Project Summary

1.1.1 Summary
AstraZenecas acquisition of the BMS Diabetes Portfolio has resulted in the need for
incorporating BMS Patient safety, AE data and Source documentation for the drugs under
consideration into its existing Adverse Event Reporting System (Sapphire).
AstraZeneca uses Sapphire as an Adverse Event Reporting System (AERS) which captures
clinical and post marketing adverse events. BMS will be using ARGUS as their Adverse Event
Reporting System (AERS) system. Currently BMS is in the process of migrating from their
existing AERS system CARES into ARGUS.
ARGUS V 7.0.3.1 will be used as the BMS Global Drug Safety System for processing
worldwide adverse event case reports for drugs.
1.1.2 Business Requirements
The Business & User Requirements Specification have been captured in the following key
document:
1. BMS Data Migration Questionnaire Developed by Cognizant with details on the
agreed scope for the project in discussion with AZ and BMS Stakeholders
This document forms the baseline scope for the project going forward.
Note: Any further changes required will need to be handled by the formal change control
process to assess impact on time, cost and quality.
1.1.3 Performance to Date

We are satisfied that the project has completed the necessary deliverables to
the level of detail that can support this project moving forward.

All risks are up to date and there are no known major issues at this time.

Although the scope of the functionality has increased, this is not significant
and is within acceptable parameters.

Overall we are satisfied with the performance of IS IRM from an IS PDM

perspective hence the Green RAG report.

1.2

Delivery Work Package Summary

This is the first delivery work package for justify phase.

1.3

Financial Summary Forecasted Costs

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GREE
N

From DP3 the overall funding required for the project over a 35 weeks period (Jun 2014 - Jan
2014) is $XXX USD, which includes a 15% contingency. Note: This includes both project and
some of the business process outsourcing costs.
Agreed budget from DP1 is still valid and the project will deliver within the budget agreed in
DP1. This is based on the actuals to date and revised estimates from Cognizant (increase of
$XXXX USD).

ACTIVITY BY GDD IS
Line item

Previous
Work
Package(s)

Justify
Initiate & Plan
Analyse & Design
Build to Close
Total
Contingency
Total Including
Contingency

This Work
Package

Estimate of
remaining
work beyond
this work
package

Actuals to
date

Totals

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0

$0

$0

$0

$0

Costs in other areas (BPO)

Total Estimated Project cost

$0
$0

2. Delivery Work Package Definition

2.1

Scope

2.1.1 In Scope:

Therapeutic Area: Diabetes

Drug Types :
o Clinical/Investigational
o Marketed

Key Brands under consideration:

o Onglyza (saxagliptin)
o Kombiglyze XR (saxagliptin and metformin HCl extended release)
o dapagliflozin (marketed as Forxiga outside the US)
o Byetta (exenatide)
o Bydureon (exenatide extended-release for injectable suspension)
o metreleptin
o Symlin (pramlintide acetate)

Cases Type:
o Transactional case data (current case version) : Open & cases still being followedup
o Historical case data versions/ audit trail not in scope.
o Only Closed Cases are in scope for this project

Data Migration
o Case Data Migration:
AWARE Safety Data and Adverse Events (for the drugs in scope) into
Sapphire

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Identification of metadata used in AWARE (ARGUS), mapping it to

Sapphire and definition & adoption of a method to update it.
Migration of all current case data (all spontaneous cases from BMS that
are not currently in AZ) , suppressed cases and old case ID from AWARE
(Argus) to Sapphire
Addition of new/additional fields (max. of 10 fields) for new functionalities
that are currently not available in Sapphire to accommodate the BMS data
Source Document transfer to Sapphire
All DIMS Source documents into Sapphire
Data flow to SMS

o
o

2.1.2 Out of Scope

Periodic reports
Updates to business and reporting rules in Sapphire
Data migration from AWARE to Jasper is considered out of scope for this project
Data migration from Empirica to AZ SMS is considered out of scope for this project
Data migration from Aris J to ClinicalWorks is considered out of scope for this project
Data migration from AWARE to PSI/SSI is considered out of scope for this project
No audit data will be migrated from AWARE to SAPPHIRE
Migration of paper based source documents is not in scope
Archival of BMS data and documents is not in scope of this project
No change will be done in RAVE and IMPACT interfaces
Any upgrade of existing systems is considered out of scope
AZDD upgrade is considered out of scope.
No additional data will be transferred from Sapphire to ClinicalWorks as a result of the
transfer from AWARE.

2.2 Assumptions and Known Risks

Assumptions
1. The AWARE (Argus) RDM & mapping doc are available prior to start of Design.
2. AWARE goes live as planned in Sept 2014.
3. Patient safety Consolidation project is completed before the migration of case from
BMS
4. SMEs from AZ and BMS should be available for the Field to field mapping exercise
and this would be critical to the integration.
5. There could be 4-5 runs to migration (based on Medimmune and Emerson migrations)
6. The migration will involve ~ 140,000 cases. (The migration will add about 15% of cases
to the existing database volume).
7. Data cleansing is expected to be minimal and is considered as the difference between
data formats stored between systems. This need to be reviewed again after the
analysis of production ARGUS data.
8. BMS database supports device reporting. Device is for drug delivery only and will
count as lowest category of medical device. Medical device handling / reporting may
need to be supported as an enhancement to Sapphire and Jasper as we need to handle
follow-up cases. Need for device information to be captured in sapphire as well as in
Jasper.
9. 10 New fields would need to be created in existing Sapphire and Jasper (in for followup Cases). Any addition to the number of fields would need to be revisited during the
analysis phase.
10. Impact to AZIA (E2B conversions) as a result of additional products yet to be
considered. Do they need to be informed for further configurations if any?
11. Argus data model will be ~99% standard (i.e. minimal customization)

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12. Data transformations from BMS to sapphire are considered to be minimal and any
changes this would need to be reviewed again after the analysis of production ARGUS
data.
Should these assumptions prove incorrect the work may be delayed and/or costs may increase.

Risk Description

Owner

CARES to AWARE data migration must be completed before

AWARE to Sapphire data migration can start

Kamlesh Shah

Significant changes are needed in Sapphire functionality (RDM,

UI, Workflow, etc.). increasing the time, cost & risk to the project

AstraZeneca

Data Cleansing is considered minimal during the estimation and

any change to this would need to be reviewed during the
justify/analysis phase

Cognizant

Availability of SMEs from BMS during the analyse and design

phase

Kamlesh Shah /BMS

Regulatory directives affect the project timescales. - Periodic

reporting must be available at the AstraZeneca side. Data
migration must be completed for periodic reporting to be
available

Cognizant

BMS cannot provide ARGUS extract files in time for Cognizant

AD team.

Kamlesh Shah / BMS

AWARE implementation is delayed past Sept 2014.This would

delay the start of Sapphire UAT as for validation reasons as they
could only be carried out on production data.

Kamlesh Shah / BMS

Data migration duration is too long for normal go-live 4 day

window.

AstraZeneca / Cognizant

Insufficient headroom for additional BMS cases & documents.

Cognizant / AstraZeneca

Patient Safety Integration is delayed past Nov 2014, causing

source docs to be migrated to SAM.

AstraZeneca

2.3

Dependencies

The project is dependent on the successful delivery of AWARE Migration by Sep 2014 as the
project can have the extract from production only after that.
The project is dependent on the successful completion of the Patient Safety Consolidation
project for the document migration approach.
The project is dependent upon service maintenance window being agreed that adheres to the
project schedule to avoid unnecessary delays.
The project is dependent upon the Maintenance projects required for the current system being
managed independently.

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2.4

Approach

As the user base is relatively small the project will go live to all users at the same time.
Data Migration
The approach has been documented in the DP512 Data Migration approach document, see
high level summary below:
Case Data to Sapphire
Establish data transfer between BMS and AZ
Copy BMS data in AZ network for migration
Upload BMS database dump into temporary schema
Extract, transform and load case data from temporary
schema to Sapphire transaction DB via ETL as per defined mapping rules
Validate and test data
Push data from transactional to Reporting data mart using existing ETL job
Push data to SMS
Archive data to Gold repository
Source Documents to Sapphire
Establish data transfer between BMS and AZ
Copy BMS data in AZ network for migration
Extract and load BMS source documents to Sapphire file system
Validate and test
Archive to Gold repository

2.5

Business Case

The short business case has been created and supplied by XXX for XXXXX and approved by
PES on dd Month YYYY.
The full business case is now ready and has been approved by PES and PIB.

3. Work Package Plan

3.1

High Level Plan

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3.2

Milestones & Work Products

MILESTONE
TARGET
DATE

30-May-2014

MILESTONE
DESCRIPTION

Justify Phase complete

MILESTONE
TARGET
DATE

25-Jul-2014

MILESTONE
DESCRIPTION

Analysis

MILESTONE
TARGET
DATE
15-Aug-2014

ASSOCIATED WORK PRODUCT / DELIVERABLE

MILESTONE
DESCRIPTION
Design

ASSOCIATED WORK PRODUCT / DELIVERABLE

DP512 Migration Approach
AP314 Data Mapping (Custom)
AP374 Conversion Mapping
IN101 Requirements Traceability Matrix
PM120 Consolidated Project Management Plan
PL162 Validation Plan
Updates to following documents if needed
IN120 Functional Specification
PL150 Solution Blueprint

ASSOCIATED WORK PRODUCT / DELIVERABLE

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PM050 Delivery Work Package

DP512 Migration approach
PM329 Risk Register
High level UI mapping
Project plan
Estimates

AP372 Conversion Application Design

AP310 Integration Functional Design- Updates
to existing
AP350 Component Design-Updates to existing

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MILESTONE
TARGET
DATE
17-Oct-2014

MILESTONE
DESCRIPTION

TE580 Test Plan

TE582 Test Approach

ASSOCIATED WORK PRODUCT / DELIVERABLE

Build

MILESTONE
TARGET
DATE
05-Dec-2014 Test

MILESTONE
DESCRIPTION

TE586 Test Scripts

ASSOCIATED WORK PRODUCT / DELIVERABLE

MILESTONE
MILESTONE
TARGET
DESCRIPTION
DATE
05-Feb-2015 Deployment

TE599 Test Report

TE598 Test Closure Memo

ASSOCIATED WORK PRODUCT / DELIVERABLE

Implementation task list as per BAU process

4. Additional Responsibilities

Cognizant will be responsible for the delivery of the solution from the analysis to the
end of System Test.

Cognizant will be responsible for the data migration of diabetes cases and Source
documents with support from AWARE(ARGUS).

Cognizant will be responsible for copying the source data in programme level
repository and AZ will be responsible for archiving it

IBM will be responsible for providing the Infrastructure required meeting the
requirements.

AZ will take over all case handling activities related to the diabetes products at the end
of migration

LDMS support will be provided by Cognizant IS QM.

BMS will be responsible for extraction of data

AZ will be responsible for facilitating communications with BMS, SMS and any other
vendor/team

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5. Financial Detail Forecast cost for this Delivery Work

Package

5.1 Forecast Costs

FORECAST COSTS FOR THIS DELIVERY WORK PACKAGE
ANALYSE AND DESIGN
Cost Type

Forecast cost
2014

Forecast cost
Total

$
$0

$
$0

Internal resource GDD IS

Internal resource EPD
Internal resource Global Patient
Safety
Internal resource BMS Business
Internal resource BMS It
External resource Cognizant
Infrastructure
Total
Cost Contingency
Total Including Cost Contingency

5.2

Cost Contingency

We have been advised that the service introduction costs could increase as the new
guidance states that they should be approximately 3% of development costs for
applications that will be developed and managed by Cognizant.
Travel costs were not included as part of the approved business case as we did not
have this guidance available then so we will need to use a proportion of the overall
contingency to fund this.

6. Financial Detail Estimated Total Cost Summary

6.1

Estimated Costs

2014

2015

Total

Hardware
Internal resource GDD IS
Internal resource EPD
Internal resource Global Patient Safety
Internal resource BMS Business
Internal resource BMS It
External resource Cognizant
Third Party Oracle
Third Party Informatica
Third Party IBM
Service Ongoing
Total
Cost Contingency
Total: This Delivery Organisation

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$0
$0
$0

PM050 Delivery Work Package

$0
$0
$0

$0
$0
$0

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Business Process Outsourcing

Total estimated project costs

$0
$0

Ongoing [support] costs / (benefits)

2010

Service Ongoing
(3,000 per month *12)
Total

$0
$0
2011

$0
$0
Total

$0

$0

$0

$0

$0

$0

$0
$0
$0

6.2 Estimating Assumptions

Rates assumptions
Cognizant based on new AD rates
GDD IS based on $XXXk per FTE
Patient Safety Global based on $XXXk per FTE
MedImmune Patient Safety based on $XXXk per FTE
Following the IPOM model 15% contingency has been added to the costings.
The estimates have been based on past experience with the SAPPHIRE and Medimmune
project.

7. Connected Delivery Work Packages

CONNECTED DELIVERY WORK PACKAGES
Document Version &
Name

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Instructions appendix:
Document pre-approval relates to the contents of this document being approved prior to
presentation at a relevant Governance Board. Details of what is being approved by area are
given below:
Area

Reason for approval

Will AZ commit to spend the $ required to deliver the remaining

phases of the project?

Will the selected solution, if delivered as planned, meet the

documented business requirements, and thus deliver the
appropriate service effect?

Does the full business case include a materially complete and

accurate financial cost and benefit forecast, including both Change
and Run costs, with clear budget allocations against future phases
of the project?

Will the appropriate funding will be in the right place, at the right
time and in the right currency to pay for the remaining phases of
the project?

Is the proposed accounting treatment of project spend in

accordance with AZ Accounting Policies?

Is the project within required AZ Risk Limits?

Are the third party costs within the business case based on
appropriate commercial arrangements?

Will the right IS project delivery resources be available at the right

time to deliver the next phase of the project?

Will the cost of the IS project delivery resources to deliver the

project be as per the business case?

Will the right SET IS resources be available at the right time to

deliver the next phase of the project?

Will the right SET resources be available at the right time to deliver
the next phase of the project?

Project
Methodology

Is the project within required AZ Risk Limits?

Integrated
Assurance

Is the project within required AZ Risk Limits?

Architecture

Will the solution comply with the AZ IS target architecture?

Will the right IS service resources be available at the right time to

run and maintain the solution?

Will the cost of the IS service resources required to run and

maintain the solution be as per the business case?

Financial

Commercial

Resources

Run

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