Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

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Merging Multiple Drug Safety and Pharmacovigilance
Databases into One Global Oracle Argus Safety System
Facilitating Globalization with Automated Configuration Loading
July 26, 2013
Rodney Lemery, MPH, PhD
Vice President, Safety and
Pharmacovigilance
BioPharm Systems, Inc.

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Agenda
• Summary of Situation
• Project Overview
• Review of Database Architecture
• Technical Overview
• Description of Methods Used
• Origin of Methodology
• Techniques Used
• Results of Methods
• Lessons Learned
• What This Means for You

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Summary of Situation
Project Overview
• A leading U.S.-based pharmaceutical company founded in the early 1980s
issued a RFP asking for assistance in the globalization of their current
Argus Safety system
• The company would be migrating three separate non-Argus safety
applications into their central Argus database
• To accommodate this migration, configuration of the data not currently
present in the global repository needs to be entered and present before
any meaningful mapping discussions could be final and executed

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Methods Used
Origin of Methods
• Argus installations contain an
Oracle DUMP (DMP) file that
contains a number of database
tables pre-populated with the
“standard” data that ships with
the initial Argus application
• BioPharm reviewed the
associated LOG files to identify
tables that were manipulated
by the vendor

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Methods Used
Origin of Methods
• Unfortunately, the desired list maintenance (LM) tables (such as
products, licenses, etc.) were not present in the DMP file
• However, BioPharm does see the use of a DMP file as vendor
precedence for the use of data manipulation language (DML) in
configuration tables of the Argus database
• Also, in our past Argus migration work, the required extract,
transformation and loading tools included DML use in the Argus backend

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Methods Used
Technique Overview

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Methods Used

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Methods Used
Techniques Used
• Given that we interface with mostly safety business users and the fact
that this configuration methodology and work is technical in nature, we
have devised a configuration requirements specifications (CRS)
document to fully document the required elements of configuration
• This MS Excel document is populated with the required elements
necessary in full configuration table population

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Methods Used
Techniques Used
• We identified the mandatory field data in the required tables and reflected
those fields in the CRS document
• Meetings were then facilitated to discuss the information in the CRS and
reach consensus to its content

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Methods Used
Techniques Used
• Since all of the Argus native constraints were kept active in the database, we
needed to reflect that constraint logic in the Excel file to ensure minimum
negative database impact
• Sometimes, constraints were enforced by the Argus application and NOT the
database

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Methods Used

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Methods Used
Techniques Used
• For mass loading of data,
BioPharm used the SQL*Ldr
application available from
Oracle as part of an advanced
SQL*Net installation
• This application requires the
creation of a control (CTL) file
that describes what file should
be uploaded into what table
• This file also contains
descriptions of the columns
expected in the source data file
and maps it to the
corresponding Argus table

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Methods Used
Techniques Used
• The corresponding CRS tab was then saved into a corresponding CSV file
referred to in the control file above

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Methods Used
Techniques Used
• Many of the populated tables, such as LM_PRODUCTS, required a number
of decoded fields from the database (such as concentration units,
formulation, etc.) prior to insertion (foreign key lookups)
• While we could have placed those required IDs in the CRS directly, the
volume of information would have been very challenging to manage
• We opted instead to use SQL*Ldr to load the more complex data into
temporary staging tables where a helper PL/SQL Package was used to
“code” the required information by executing a series of lookup functions
to return the required ID fields that are required to adhere to referential
integrity

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Methods Used

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Methods Used
Techniques Used
• SQL*Ldr can be executed through the standard MS Command line
interface on any windows machine
• The execution command requires the control file

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Methods Used

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Methods Used
Assumptions and Risks to Remember with this Methodology
• The BioPharm methods explained here do NOT disable the native
constraints and triggers used by the Argus database
• All information loaded into the tables must comply with these native
table constraints
• There is a possibility that certain Argus application level triggers or
constraints are being bypassed in this methodology beyond those
already identified within these slides

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Methods Used

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Methods Used
OQ/PQ Testing
• Once the CRS is final, BioPharm suggest documenting the user
requirements in a separate document referred to as a User Requirements
Specification (URS)
• This document should contain all of the high-level requirements for the
globalization of the system including any major aspects of the system
that the users are concerned over given the risks of using a database
level loading of configuration

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Results
Impact on Globalization
• Saved ~39 days in
configuration
work
• Empowered the
company to reuse
the scripting in
future
globalization
efforts
Configuration Type
Configuration
Item Count
Estimated
Manual
Time
Actual
Load
Time
Saved
Time
Products 1789 7.5 0.008 7.492
Ingredients 1927 2 0.008 1.992
Licenses 4242 26.5 0.008 26.492
Datasheets 1178 1.2 0.008 1.192
Reporting Rules 156 1 0.008 0.992
E2B Receivers 70 0.6 0.008 0.592
E2B Senders 68 0.6 0.008 0.592
Manufacturers 57 0.1 0.008 0.092
TOTALS 9487 39.5 0.063 39.436
Table 1: Estimated Time Savings From Configuration
Development Scripts (all time in days)

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Lessons Learned
Improvements for Next time
• MS Excel constraint and lookup columns were not always hidden from
user view when reviewing this complex document and should have been
• As many decisions on the data in the CRS were driven by Argus business
use, importance should be placed in how the application is to be used
before configuration data is uploaded
• All end-users should actively participate in these decision discussions as
the data will impact their entry, management and analysis of safety
information
• Automation of the CSV files from the MS Excel sheets

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Ways to Engage…
• For those ready
• Proof of concept
• For those not quite ready
• Schedule early engagement calls to provide guidance on similar projects
• For those in the midst of a globalization
• Refine your approach with guidance calls to review your approach and
evaluate if BioPharm’s methods might be useful to your organization
What this means for you?

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Questions & Answers
2000 Alameda de las Pulgas
Suite 154
San Mateo, CA 94403-1270
www.biopharm.com
Rodney L. Lemery MPH, PhD
Vice Pres. Safety and PV
Tel (650) 292-5310
Fax (650) 292-5301
rlemery@biopharm.com