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Regulatory Case Studies: Register Enables Compliance and Tracking for Post-Merger Global Pharma

Customer Background

In many western countries, healthcare is available and accessible to just about everyone. But in many parts of the world, this is not the case. A global pharma organization headquartered in Asia discovers and produces innovative medicines that create a better future for patients in disease areas where there is a large unfulfilled medical need.

With close to two centuries of experience and more than 10,000 employees, the organization strives to develop treatments that are the very best for patients worldwide, especially those in areas that most need healthcare solutions.

Business Challenges

But in order to do that, the company knew it had to first upgrade its existing system to capture interactions that were happening between the company and regulators. Regulatory actions that needed to be undertaken didn’t have a defined workflow. Tracking was also hampered and projects were postponed, due to insufficient data entry.

Requests would go back to the originators, who were not within the Regulatory Information Management (RIM) system, thus adding to lead times for new product launches.

The most critical aspect was trying to meet compliance requirements. The company turned to ArisGlobal to address this pressing business need.

Solution Selection & Implementation

The organization wanted to be XEVMPD-compliant to meet the needs of its core business. The regulatory affairs (RA) function wanted to establish a quality source of information not only for RA but for other functions, as well.

Tracking, data entry, and not being able to include workers outside the RIM system, all lead to longer product launch times. The company, like many others after a significant merger, was unable to satisfy its internal customers and regulatory requirements with its exiting tools. The company started to look for a solution that would change all of this.

The company sent out an RFP, and eight vendors applied. At the end of multiple rounds of detailed consideration, the number of vendors was reduced to four.

RA and the IT department were key stakeholders in this process, with pharmacovigilance being present in an observer role. Because there was no defined workflow, the chances of efficiently reaching its goals was impossible for the company.

In terms of the key criteria for the selection of Register, the customer felt that the solution provided by the previous vendor did not meet its expectations and the service level provided by the previous vendor was considered suboptimal. These turned out to be critical factors for consideration during the RFP process.

With Register, the company was able to see how various business processes related to each other. The breadth of functionality and business process visibility provided by ArisGlobal Register helped the customer gain confidence in Register’s suitability to meet its needs.

What also helped was the fact that its parent company had a good experience with Register in the past. This played a key role in the decision making process.

Business Benefits

The key benefit of using Register is that the organization has achieved its compliance objectives, and gained greater oversight and understanding of products in the market, including the status of individual products in different geographies.

Now that the ArisGlobal solution is in place, active recipients of this information are supply chain, manufacturing and Pharmacovigilance. For example, manufacturing needs to have approval data before launching the production process. Since pharmacovigilance- PSUR planning is included in the system, compliance reporting and workloads are based these days on the information from the Register system.

Passive recipients of this information are the finance function. Reports originating from regulatory affairs are used for financial reporting by the finance function within the company.

The customer has reported that it has found Register to be reliable and able to better manage the company’s RA goals and challenges.

And when the customer was asked how the company felt about ArisGlobal’s solutions and implementation, once the engagement cycle was completed, the response was, “ArisGlobal represents a partner, not just a vendor.”

RA in this organization is now queried for information by its supply chain, manufacturing, medical affairs and finance, among other functions. What is perhaps as important as the company’s ability to be able to meet compliance objectives is that the project has also increased the department’s visibility in the organization.

Register has enabled compliance and tracking for the organization. The system has also established the RA division as the single source of truth for various functions within the organization.

A major pharma which recently underwent a merger had to capture interactions that were happening between its system and regulators. Inefficient tracking and compliance were adding lead times for product launches thus impacting revenue. A world class tracking and compliance solution was required to drive efficiency for the organization.

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