- Complying with diverse regulatory standards across 30 international markets
- Accelerating development and delivery of periodic clinical trial reports to authorities
- Reducing the risk of compliance failure while increasing operating efficiency
- Otsuka Pharmaceuticals Co. is using Logi Symphony to create an end-to-end reporting platform for its drug and medical devices practice.
- Delivered timely, verified clinical trials reports to more than 30 international regulatory agencies
- Increased productivity by more than 300% by eliminating manual reporting processes
- Generated more than 300 unique data outputs for internal and external audiences
- Reduced report development time from two months to less than two weeks
Creating Modern Miracles
Miracle medicines don’t just happen overnight. The pharmaceuticals that save lives and improve quality of life go through rigorous research, development, and testing for years before ever hitting shelves. For Otsuka Pharmaceuticals, the lengthy and arduous process is just a fact of life and a cost of doing business.
The company has spent nearly a century focusing on creating solutions for better health worldwide. Today, Otsuka delivers innovative neuroscience, oncology, cardio-renal medicines, and medical devices to more than 30 countries. But as its business footprint has grown, so have the challenges of delivering new products to an ever-growing list of global markets.
“Each country has its own authority that oversees product safety testing, reporting, and the decision about whether or not a product can go to market,” says Rajesh Pandey, Associate Director of the Safety Data Management (SDM) Group at Otsuka. “We wanted to find a way to collect and organize the required data for each country’s regulators faster and make sure that the information we reported is as accurate as possible.”
The Complex World of Global Compliance
Getting a new product to market—and keeping it there—is a lengthy and time-consuming process. Otsuka must put all its products through rigorous clinical trials and testing for safety and efficacy, compiling data from patients participating in trials around the world and meticulously recording each outcome—positive or adverse—for regulators to evaluate.
Data must be aggregated, analyzed, and organized into specific reporting formats for government authorities in every market in weekly, monthly, and annual intervals. In the past, Otsuka relied on manually driven, disparate processes to aggregate the data required by the various governing and regulatory bodies.
“We had colleagues in each region of the world collecting and building as many as 60 different reports, lists, and tables for every governing body,” Pandey says. “The sheer volume of work and the fact that our data has to be accurately made it extremely difficult to continuously meet deadlines to remain fully compliant.”
Pandey says that regulators occasionally granted extensions for extenuating circumstances, and Otsuka regularly contracted additional resources to help manage the workload. “Extensions and hiring more people were short-term solutions to a long-term challenge,” he says. “With the number of reports we have to produce, it became imperative to find ways to bring greater efficiency, cost-effectiveness, and consistency to our operations.“
Essential Reports Without Delay
Eager for a new approach to meeting its varying compliance standards, the Otsuka team gathered consultants and colleagues to brainstorm ways to consolidate and streamline data collection and reporting.
After developing new data collection processes, the team needed a software solution to put it into action and standardize its reporting activities. The company evaluated solutions from several well-known vendors but chose to deploy Logi Symphony because of its compatibility with legacy data systems, intuitive setup, and automated operations.
Logi Symphony seamlessly integrates with Otsuka’s Oracle database and Argus pharmacovigilance platform application to greatly accelerate reporting time-to-delivery and help to ensure that the data the company uses for reports is completely accurate. Unlike other solutions, Logi Symphony doesn’t require intermediate data modeling processes to create reports, which can jeopardize data integrity while also adding critical hours or days to the reporting function.
“Logi Symphony lets us skip data handling steps that add unnecessary time and risk to our operations,” Pandey says. “Not only can we be sure that the information we’re providing is as accurate as possible, but we’re also able to schedule automatic report delivery and make sure we don’t miss a reporting deadline that could result in a non-compliant status, costly audits, or even having to suspend operations in a particular market.”
New Tools of the Trade
One of the biggest advantages of using Logi Symphony is the ease and speed with which Otsuka can create new reports and formats. Otsuka team members use the tool to rapidly design and deploy a range of interactive, elegant reports to meet the individual requirements and demands of international regulators as well as internal stakeholders.
In the past, reports had to be created locally, with Otsuka employees in each region responsible for collecting information, collaborating with local authorities, and trying to organize them into specific report layouts as dictated by regulatory agencies. With Logi Symphony, those tasks are centralized. Pandey’s team can generate an array of reports covering topics such as patient medication reactions and trial outcomes at the individual participant level and lay the data out to regulators’ exact specifications for more than 30 markets.
Logi Symphony’s intuitive interface enables virtually any Otsuka employee to easily select the appropriate data sources, create specific queries, and design a layout to a governing agency’s specifications. The software’s drag-and-drop functionality lets the report developer choose from over 40 types of charts, tables, crosstabs, and other components to customize the look and feel of the reports and make essential information easier to read.
“Logi Symphony is an easy and light tool that lets anyone in our organization become a report designer with very little training,” Pandey says. “With just a handful of resources, we’re able to push out nearly 300 different outputs for internal use and create more thorough reports for external audiences from a single platform.”
Enhanced Productivity and Greater Reporting Transparency
Deploying Logi Symphony has helped Otsuka modernize and simplify its complex reporting responsibilities. In contrast to the disparate and disjointed manual processes of the past, Logi Symphony unifies and automates many of the most time-consuming data collection and reporting tasks. Now, Otsuka can remain compliant and competitive across its geographic centers of operation with less effort, in less time.
Pandey says that his team no longer requires extensions on report deadlines and has significantly improved its resource management. “Our productivity overall has increased by more than 300% since deploying Logi Symphony,” he says. “Reports and presentations that used to take two months to compile now take less than two weeks because every aspect of the process is simpler and more straightforward.”
The increased efficiency has not only saved Otsuka a lot of time but has also helped the company avoid the financial calamity that comes with unverified data and failure to comply with regulatory standards. Pandey says that the consequences of non-compliance can devastate a company because of the cost to redo the work, hefty fines, and other penalties, which can easily reach tens or hundreds of millions of dollars.