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Oracle Customer Success—Acorda Therapeutics
Acorda Therapeutics Improves Safety Insight and Streamlines Regulatory Compliance
ShareOracle Argus Safety enabled greater and faster insight into product-safety signals, improved productivity, and streamlined and automated FDA safety reporting. Acorda is committed to patient safety, and the Oracle Argus platform helps us maintain high compliance standards.
— Thomas Aquilina, Vice President, Drug Safety and Risk Management, Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological disorders.
Acorda markets three therapies approved by the US Federal Drug Administration (FDA), including AMPRYA (dalfampridine) extended release tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS), as demonstrated by an increase in walking speed. The company has one of the leading pipelines in the industry for novel neurological therapies. Acorda is currently developing a number of clinical and preclinical-stage therapies. This pipeline addresses a range of disorders, including post-stroke walking deficits, Parkinson’s disease, epilepsy, heart failure, MS, and spinal-cord injury.
Business Challenge
- Maintain a high level of compliance with US Food and Drug Administration (FDA) pharmacovigilance and safety reporting requirements
- Gain greater control over, rapid access to, and extended visibility into the firm’s safety data, managed by a third-party vendor
- Improve safety-team productivity, enabling members to focus more time on analyzing and investigating events and trends instead of compiling reports
- Maintain timely, streamlined, and cost-effective management of the safety-reporting environment—ensuring high availability for the business-critical system and freeing internal resources for other strategic business priorities
- Ensure that the safety system is robust and flexible to meet the needs of a pharmaceutical company that has a diverse team of healthcare professionals
Results
- Deployed Oracle Argus Safety and Oracle Argus Insight on the premises, with Oracle partner Covigilant, LLC managing the solutions, to maintain a highly effective and available pharmaceutical safety-reporting environment that streamlines regulatory compliance, supports timely identification of and response to potential issues, and boosts productivity
- Extended visibility into potential drug safety issues with a robust system that automates case narratives and integrates case data and logic—delivering deeper insight into individual potentially adverse events as well as trends over time across the global enterprise and its patient community
- Streamlined compliance with FDA requirements regarding timely reporting and investigation of potential adverse events and drug-safety issues
- Maximized Oracle Argus capabilities by bringing it in-house with partner Covigilant, with automated workflows and the ability to electronically submit FDA, individual case safety reports
- Accelerated report creation and their accuracy with an array of built-in reporting rules and reusable safety reports for performance metrics, signal detection, and compliance monitoring
- Put information that safety team members require at their fingertips with Oracle Argus Insight, eliminating delays associated with asking the third-party vendor to run queries
- Extended management visibility into safety trends with performance-metrics reports
- Increased flexibility and timeliness of ad-hoc reporting from the database
- Improved safety and signal data quality and processes via edit checks, local control, and standard operating procedures
- Boosted ability to rapidly evaluate adverse-event case data and determine the correct destination for follow up
Why They Chose Oracle
Acorda, with its commitment to best practices in the pharmaceutical industry, had experience with Oracle Argus solutions via its third-party vendor. When deploying a safety solution in-house, the company considered its options and determined that Oracle Argus Safety offered the appropriate capabilities and was a recognized industry leader.
The Oracle Argus platform offers a solution that can grow with us as we deliver more novel medications to the market. Working with our partner Covigilant to move this platform in-house has enabled us to maximize the value the Argus platform brings to our company.
— Thomas Aquilina, Vice President, Drug Safety and Risk Management, Acorda Therapeutics
Execution
The implementation process was a joint effort between Oracle partner Covigilant and Acorda’s Drug Safety and Risk Management team, IT, and its internal quality department. Acorda Therapeutics needed to ensure a smooth launch and flawless performance, so it conducted extensive testing before deploying the solution.
About Acorda Therapeutics
Headquarters
Ardsley, New York, United States
Employees
400
Annual Revenue
$100 to $500 Million
Partners
Covigilant, which implemented and now manages Acorda Therapeutics’ Oracle Argus environment, brought along its deep experience in creating drug-safety tracking and reporting environments for the pharmaceutical industry. Its professionals function as members of the Acorda team, delivering onsite and remote support and resources and ensuring high standards and best practices to meet Acorda's unique needs.
Oracle Solutions Used
Published: Mar 06, 2015