The successful execution of a safety system migration requires a meticulous strategic approach with the right use of tools and techniques to ensure data integrity, quality, security and regulatory compliance. With a decade of practical experience in both safety systems and case data migration, Techsol’s Drug Safety domain experts have engineered a lean, practical and risk-based data migration framework to fulfill our clients business goals.
We have successfully delivered over 100 safety case data and content migrations, across 30+ customers using 10+ platforms since 2010. Based on the source system, we can consolidate, harmonize and migrate case data to the newly established qualified safety database.
How AccelMigrate Has Helped Clients
Based on our extensive technology and drug safety domain experience, our team developed “AccelMigrate”, a turnkey migration methodology to qualify the entire data and content migration and migration testing process. To address key business risks and unforeseen challenges, our data migration qualification methodology and deliverables are tailored to ascertain data integrity and regulatory compliance. The technical process involves a standard ETL procedure that has multiple quality gateways with data validation and data integrity checks.
The AccelMigrate methodology encompasses a 5 Stage process covering the end-to-end execution of data migration and qualification. Each stage has a specific set of pre-defined and agreed deliverables that are critical to a successful migration.The high-level description of the overall data migration process is depicted in the below illustration.
Our AccelMigrate methodology has been tried and tested multiple times for different types of migration needs and on various source and target systems. Our AccelMigrate offers out-of-the-box and pre- validated solutions for a wide variety of other source systems, applications and technologies.
- Oracle Argus Safety Suite
- Aris Global LSMV
- Oracle AERS
- Ennov Safety
- ABCube
- PVWorks
- PV24x7
- PVNet
- Clintrace/ Empirica Trace
- Spreadsheets
- XML files
- SharePoint
- Custom software
- Oracle Content Management
- SFDC Force.com
- Veeva Vault
Latest News & Updates
How to Proactively Prevent Clinical Trial Protocol Deviations and Protocol Violations
Understanding the Importance of a Clinical Trial Protocol The fundamental objective of a clinical trial protocol is to provide common scientific guidance on how to conduct the clinical study in a regulatory-compliant manner and gather data that will ultimately provide answers on the safety and efficacy of the investigational medicinal product. The Guidelines for Good [...]
Food & Nutraceuticals: How Companies can Prove Health Value with Clinical Trials
What are Food and Nutraceuticals? ‘Nutraceuticals’ is a composite term of ‘nutrition’ and ‘pharmaceutical’. They are a blend of products that possess both nutritional as well as medicinal value. They are designed to improve physical health, boost immunity, and deal with stress and increase longevity. Nutraceutical products play a significant role in maintaining normal physiological [...]
Best Practices for Signal Management in Pharmacovigilance
Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]