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Global biopharma company drives operational excellence across safety, medical affairs, and regulatory affairs with Indegene​

By automating operations and applying deep healthcare expertise, Indegene is enabling this biopharma company keep its patients safe, accelerate medical content creation, and comply effectively with evolving regulations.

For over a hundred years now, the American multinational biopharma company has been leading the way in human healthcare and research. Today, the biopharma giant operates a large portfolio of innovator, prescription and over-the-counter products, and vaccines across major therapeutic areas.

The company relentlessly pursues breakthroughs that enhance patient lives and make the world a healthier place. It consistently ensures that the processes and culture of the company evolve with time to support its bold vision and growing scale of operations. No wonder then, that transformation for a digital world is a key tenet of its business strategy.

Indegene has been partnering with this global biopharma leader for over 12 years now. It has been driving operational efficiencies across 185 countries. It supports the company across a broad range of functions including regulatory submission planning, aggregate reporting, pharmacovigilance (PV), editorial review, medical content creation, labeling content, and artwork. The company counts Indegene as one of its top 5 strategic partners for digital enablement, value creation, quality outputs, and customer satisfaction.

Managing a growing volume of safety adverse events with automation

Covid-19 was a true test of resiliency for the world. With an astronomical number of vaccinations to be administered across the globe, this biopharma company had very little time to set up large-scale operations to manage any sudden upsurge in adverse events from the vaccine. It also needed to solve for faster processing time and lower cost of operations. Manual operations for case processing typically take more than 60 minutes per case, with Individual Case Safety Report (ICSR) identification taking the majority of the time.

Indegene deployed its AI and ML-based NEXT Adverse Events Management to automate case processing for this biopharma company. The platform automated many processes including case prioritization, data source ingestion, data entry, coding, listedness assessment, narrative generation, and submission in R3 format to the safety database. A team of over 350 Indegene pharmacovigilance experts was onboarded in less than 12 weeks to manage quality and medical review processes in a managed services model.

Indegene's NEXT adverse events management platform dashboard

As a result, the biopharma company managed over 2x the number of cases, with more than 98% accuracy at 100% compliance to timelines and 50% lower cost, in the process enabling it to further its purpose of affordable and quality healthcare for all.

Adverse event cases managed
Processing accuracy
Lower cost

Simplified and faster medical and editorial content review through deep healthcare expertise

The biopharma multinational has also made significant strides in driving operational efficiencies of its medical and editorial content review (MLR) operations through a dedicated Center of Excellence (CoE) model by Indegene. The CoE manages editorial and medical reviews across 28 products spanning 14 therapeutic areas, which include global review of medical communications materials developed by global medical affairs and medical information teams as well as technical accuracy checks involving medical accuracy and reference checks, ensuring objective presentation of data and absence of any off-label product promotion Since 2015, the CoE has delivered proof-reading and material co-ordination for over 65,000 assets till date.

Lower costs
Accuracy in error detection
Quality of submissions

Faster and successful regulatory submissions through technology and regulatory knowledge

Indegene also partnered with this biopharma company in its regulatory affairs operations. The biopharma company was challenged with capacity constraints and difficulty in tracking regulatory submissions due to a rapidly growing portfolio of drugs, biologics, and consumer healthcare products.

Indegene deployed a dedicated CoE for regulatory writing and execution for this company. Indegene’s regulatory affairs experts managed the company’s regulatory content review and publishing processes. Indegene improved quality controls and ensured compliance with standard operating procedures (SOPs) with consistency and completeness of information, language, correlation, and cross-referencing between document components. It also streamlined capacity management for regulatory writing requirements and drove efficiencies, despite the rapidly growing product portfolio.

Excellent work on a very difficult document with a very tight deadline! I would have never had the document ready on time without the team’s work on it! Priceless!

- Director, Medical Writing

The CoE leveraged NEXT Regulatory Submissions Planning to optimize, plan and track regulatory submissions for the company across 185 countries. The biopharma company was able to maintain a content quality score of <0.5 errors per page and save up to 42,000 hours per year in submissions through process improvements. It enabled timely submissions while ensuring compliance with regulatory requirements.

NEXT Regulatory Submissions Planning is our best digital tool. Even with more functionality added over time, it remains a simple-to-use tool. Designed with the actual end-user needs in mind.

-Regional Regulatory Hub Strategist (RRHS)

The same biopharma company also had major challenges complying with regional labeling regulations for its product portfolio across 10 countries in the Asia Pacific. Indegene’s end-to-end labeling CoE for this company included experts with a thorough understanding of the Asia-Pacific regulatory landscape and local language capabilities. Indegene managed local label creation, updates, submissions coordination, translation, and proofreading for the biopharma company in a compliant manner. It also included the creation and maintenance of regional labeling documents, patient information leaflets, and liaising with regional affiliates for HA query resolution.

Indegene ensured compliance with local label regulations through creation, proofreading, and updates across more than 7,000 labels. It improved labeling accuracy, operational efficiency, and compliance across the portfolio, with 99.5% first-time-right submissions.

First-time-right submissions
Content quality score
Hours per year saved

Enabling future-readiness for higher scale and complexity

Through a combination of deep healthcare expertise and fit-for-purpose technology, Indegene not just delivered outcomes that matter to this biopharma company today, but also set up its safety, medical affairs, and regulatory affairs operations to be future-ready.

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