Case Study

Custom Regulatory Information Application for a Pharmaceutical Provider

Our client is a world leader in pharmaceutical technologies and services for the healthcare industry. It is present in 80 countries with approximately 67,000 employees and serves more than 3.7 million customers and patients.

Challenge

The pharmaceutical industry is highly regulated, and our client must document its products’ regulatory information to ensure compliance. It must manage the submission of the regulatory dossiers (regulatory events), as well as track detailed product information.

They had initially purchased a tool from the pharmaceutical market in order to create and maintain this information, but it did not meet their needs. They were looking for a new solution that could provide full lifecycle management with a centralized, global view of product details, documents and submissions, and that could support collaboration and meet compliance requirements.

The timeline was tight and they needed the new system to be completed and in place within 4 months.

Needs

Oracle took note of our client’s challenges and contacted its long-time partner Insum. Together they presented an offer that would:

  • Recover, clean, and migrate existing data to the new platform
  • Ensure data integrity
  • Reduce data entry through a more straightforward process
  • Provide the end-user with a highly intuitive interface
  • Reduce overall costs.
  • Offer great flexibility in configuration
  • Be better suited to their present needs while being easily scalable if needed.

Oracle, aware of Insum’s APEX expertise, knew it would build the application to the highest standards and within budget while respecting the client’s tight timelines.

Agile methodology

  • Regular meetings
  • Frequent deployments
  • Knowledge transfer

Approach

Given the project’s tight timeline, Insum opted for an agile approach, thoroughly integrating our client into the process.  There were 2-3 meetings a week with project stakeholders, and regular deployments with demos roughly every 3 weeks. The frequency of these Insum/client meetings ensured there were no surprises.

Meetings almost always included developers, the tech lead analyst, and client users to eliminate any knowledge gaps that could slow the process down.

The client’s team also conducted work sessions on its own to ensure unified feedback and requests.

To ensure smooth adoption of the new application and of the Oracle Autonomous Database, knowledge transfer sessions were jointly conducted by both Insum and Oracle.

Technology used

This solution included Oracle’s fully managed Autonomous Database (Autonomous Transaction Processing), and Oracle Application Express (APEX), the Oracle Database’s Rapid Application Development platform.

Oracle’s Autonomous Database, which hosts the APEX application, was deployed within a day and a half, and work on the APEX application began immediately thereafter.

The Autonomous Database is an optimal solution, ensuring a high level of data security for the client’s sensitive information, while also minimizing maintenance efforts thanks to its self-driving, self-securing, and self-repairing capabilities.

Results

Our client now works with:

  • An application that’s fully adapted to their needs: secure, simple, very interactive, and performant, with no duplicate data entry.
  • Zero application licensing costs as APEX application and user costs are already part of the Oracle Database license.
  • A fully scalable and fully managed-by Oracle infrastructure that can easily be adjusted to the size of the application as well as other workloads that the client has planned for it.

“Thanks to Insum’s professionalism and technical knowledge, we have now a database that precisely answers our needs. The development of the tool went perfectly well: rapid development through an agile mode, favorable working hours with the time difference between our country and Canada, very good coordination, and communication between our teams, and very open-minded and nice people!”

– Anne-Sophie – Director, Regulatory Affairs, pharmaceutical provider

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