Data Migration Services for Clinical Data & Drug Safety Software

Over the past ten years, CSS Informatics has successfully migrated 150 clinical data and drug safety environments.  This work represents tens of millions of critical records that must maintain their validated state.  With our pharmaceutical software migration services we offer:

Effective migration of clinical research and drug safety data through a predictable and validated conversion process

Proprietary software tools like TableTrans® and techniques to assist in seamless data migration

Practical experience with Clintrial™ to Oracle Clinical, Oracle® AERS, Empirica Trace™, Argus Safety™, and ARISg™ data migrations!

Samples of drug safety software data migration projects that we have performed:

ARISg to Empirica Trace

Oracle AERS 4.0/4.3 to Oracle AERS 4.5

Empirica Trace 2.6/2.7 to Empirica Trace 2.8

ARISg to Oracle AERS

Argus Safety to Empirica Trace

ES1-SafetyManager® to Empirica Trace

Empirica Trace to Argus Safety

ARISg to Argus Safety

Empirica Trace to ARISg

Custom safety systems and E2B data migrations

Download our Data Migration Overview

We are recognized throughout the pharmaceutical industry as experts in the development of data migration software and have been pivotal in ensuring the success of many critical, large scale clinical data migration projects.  Check out our "Rule of Thumb" tip for drug safety migrations below.

Unlike most firms, we have our own proprietary software tools and techniques proven to accelerate the data migration process.  These include our TableTrans® data transformation system for custom data migrations and eLoader, for data migrations into Oracle Clinical.

Legacy Data Migration
Data Migration Experience (Oracle Clinical, etc.)
Technology for Data Migration

Legacy Data Migration

Through the years, we have developed a flexible methodology that will provide a proven, validated conversion process.  We understand that every data migration is unique, yet the same concepts and principles apply to each project. 

Our comprehensive approach includes: 

Completion of our three-page, 30+ item questionnaire
Analysis and creation of a comprehensive mapping specification.  Far more than just "this field goes to that field", our document

   contains 16 distinct data points for each mapping relationship.
Address the tough issues.  Many of the same problems occur in every adverse event software migration.  These include:

 

    > What to do with data in the source system that has no place in the target system

    > How to handle the audit trail

    > Maintaining the reporting history so that the initial / followup status continues sequentially in the new system

    > How to deal with expectedness and causality

    > Assuring the legacy (source system) data is E2B-compliant

    > Addressing any medical dictionary updates or conversions needed for coded events, medical history, and drug data

    > Determining how complex data derivations will be formed

    > Generating system keys (primary, secondary, etc.) that tie together case data and do not violate unique value constraints

 

Creation of the SQL and PL/SQL migration source code using our proven, proprietary software - TableTrans.
Statistical verification of migrated data including number of cases, number of records, and codelist correlation.

Tracking logic to assure that continuing data entry in the source environment does not introduce new values that might affect

   data-dependent mapping algorithms.

Primary deliverables for a full project typically include:

Data Migration Plan

Detailed Mapping Specification

Data Migration Source Code

Statistical and Functional Testing Results

And the successfully validated and migrated data

Data Migration Experience (Oracle Clinical, Empirica Trace, ARISg, Argus Safety, Oracle AERS)

We have performed numerous clinical and safety system conversions for Top 50 pharmaceutical and biotechnology companies.  References and case studies are available upon request.

CSS Informatics employs primarily senior and principal-level personnel with a minimum of five years of IT and pharmaceutical experience.  The average relevant experience of our consultants is more than a decade.  A number of our consultants started their career helping create and refine the commercial software systems that you use today.  As a result, we offer a unique insight into clinical and safety databases that will help avoid data integrity nightmares.

Our professional staff has proven skills in:

project management
data modeling
software development
data analysis

data mapping and problem resolution
computer system validation
regulatory compliance

Don't let your data migration project become someone else's learning experience!

Rule of Thumb for Safety System Data Migrations

If you have no more than 1,500 to 2,000 cases to migrate from one safety software system to another and you do not need to migrate the AUDIT trail, it is usually less expensive to have the legacy cases hand-keyed into your new drug safety software than to have migration scripts developed and validated for automating the process. 

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Technology for Data Migration

We have developed specialized software tools to assist with data migration:

eLoader, comprehensive data loading and conversion.  eLoader is a sophisticated tool for pre-processing and loading data into Oracle Clinical and other Oracle database targets.  It provides a set of tools for loading studies from legacy systems or for routing loading of lab data.  We have even used eLoader to successfully migrate Clintrial studies to Oracle Clinical!

 

 

Load data into OC and TMS without programming
Load data into Patient Positions, Sites and Investigators
Automate OC data loading tasks
Simplify and speed up controlled OC data loading
Use data specified in a wide variety of common clinical data formats

  Find out more about eLoader!

 

 

TableTrans® visual data transformation system. TableTrans utilizes an intuitive, step-by-step graphical interface for the definition of the conversion process. TableTrans produces both production-quality SQL output and extensive transformation documentation and data summaries for use in quality assurance.  Due to our extensive experience we have existing TableTrans migration libraries for most commercial drug safety systems.  This offers even greater time and cost savings by providing the base mapping algorithms as a starting point.

Specify, execute, and automatically document complex data transformations
Specify and extract transformed data interactively or in batch mode to files or

   databases
Provides a wide range of built-in transformation operators and database functions to

   minimize programming
Replaces intricate programs written in statistical or database languages
Includes features specifically designed to support compliance with 21 CFR Part 11

 

  Find out more about TableTrans!

 

                                                  Mapping packages available for many adverse drug

                                                  reaction reporting system combinations