Post Market Surveillance Medical Device

Client Background

The client is a multi-billion global medical device and pharmaceutical company, with broad portfolios in injectables, infusion therapy, and medication management solutions.

Industry Landscape

Regulatory agencies governing the life sciences industry have been continually increasing monitoring of adverse events and product complaints. It has become critical for companies to efficiently handle product complaints and streamline their reporting processes to avoid costly recalls and warnings from regulatory agencies.

The Opportunity

In response to rapid business growth, competitive pressure and global recession, the client launched an organization-wide transformation initiative focused on driving operational excellence. The client had gaps in standard processes and unstructured complaint handling and medical information fulfillment frameworks. They partnered with Wipro to set up a workflow process that would aggressively pursue greater internal efficiencies, strengthen its financial position and establish a stronger foundation for its future as a leader.

Solution

Wipro set up an offshore delivery center for the client at Cebu city, Philippines. This center had a rich pool of nurses and pharmacists required to manage the process of global product safety, complaints handling, medical information dissemination and fulfillment.

The process assessed events for potential risks and determined regulatory reporting requirements. Intake, registering, tracking, and follow up of all customer complaint reports for client ‘s manufactured and/or distributed products till closure of complaints was also done. The customers included - but were not limited to - pharmacists, doctors, nurses, dentists, researchers, marketing, customer care, and sales force.

Medical information fulfillment and imparting client product specific information through written or verbal form for over 3,000 products could be done which included generic drugs, proprietary drugs, and devices. The lab set up in Cebu city had models of most products which was also used for training purposes and make the transition seamless.

This model mitigated any business disruption risks and was implemented across APAC and US and soon to be implemented in EMEA. Wipro partnered with the client in facilitating Kaizen Projects (overall complaint management, devices complaint cycle time reduction, experience code standardization, drug complaint registration and closure) and also participated in the projects as a team member – a unique honor for Wipro.

Business Impact

Streamlined processes and systems have led to greater internal efficiencies with optimized efforts (average customer call handling time reduced by 36%) and reduction in upfront operational costs by 15%
Process improvements in overall complaint management, devices complaint cycle time, drug complaint registration and closure
Cost reduction and improved profitability
Improved efficiencies through process harmonization across divisions.
Ensured timely triage and resolution and higher device up time.

Full spectrum of Post Market Surveillance services delivered through a global model leading to consolidation of complaints intake and management centers.

"It is truly amazing how far our team has come since beginning this journey a year ago! We would not have been as successful as we are today without Wipro’s continued support. A big thank you goes out to the Wipro team for contributing to the success of our call center. I look forward to raising the bar ‘even higher’ in our second year of operation" - Associate Director, Global Medical Communications

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Global Post Market Surveillance Hub

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