medical affairs operations are unable to personalize medical information

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73% 

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adverse events were reported to the US FDA from 2013-22

16.9 million 

of regulatory operations’ technology maturity is basic

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Let’s partner for #FutureReadyHealthcare

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Communicate scientific information effectively, improve regulatory compliance and manage safety operations efficiently

3.6rem

Enterprise Medical Solutions

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Omnichannel strategy in Medical Affairs

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MM+M Podcast: The new drug-price chessboard

Pharmacovigilance ICSR processing automation

Regulatory intelligence - Key to successful submissions

Maximizing impact of medical information websites

Pfizer's digital transformation story

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Insights to build #FutureReadyHealthcare

to meet changing expectations on medical and scientific content

Suboptimal

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to meet growing volume of adverse events being reported

Unscalable

to comply with rapidly changing regulations across markets

Overstretched 

Existing medical operations are

We enable medical affairs organizations with core domain expertise and technology to deliver consistent and customized medical and scientific information

2.7rem

Personalize physician, patient and payer experience

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We empower safety teams with insights and technology to proactively monitor, analyze and report adverse event signals and manage risks effectively

Reduce total cost of pharmacovigilance operations

Our life sciences-contextualized technology across the product development lifecycle ensures 100% compliance in a complex and dynamically changing regulatory landscape

Improve success and speed of regulatory approvals

Adopt technology to accelerate and scale medical outcomes

Transform MLR review productivity with AI/ML 

Streamline HA Query management

Transform automated case intake and processing

Indegene automates ICSR compliance monitoring

Indegene helps scale dossier submissions by 50x 

Improve efficiency of creating PILs

Case studies

Every life sciences company is at a different level of omnichannel medical operations maturity. We partner with you across the omnichannel engagement value chain - from understanding your strategic objectives and defining personas to building and operationalizing a bespoke omnichannel roadmap and measuring outcomes. Through effective pricing strategy assessment and competitive engagement simulation, we simplify your medical omnichannel adoption and translate your medical imperatives into tangible, measurable outcomes.

Omnichannel Medical Strategy 

We enable accurate, impactful and compliant external communication across regulatory, medical and commercial functions through a comprehensive material review, both by institutionalizing medical, legal and regulatory review (MLR) functions and by improving the efficiency of existing review flows. With MLR advisory services, we correct process bottlenecks, optimize operations and drive analytics-led governance.Our MLR operations team specializes in end-to-end material review and approval, ensuring high-quality evidence against scientific statements and promotional claims as well as regulatory checks for guideline conformance. We also perform editorial checks around language, proofreading, style-guide conformance and plagiarism. We apply technology to accelerate the MLR review process - from claims validation and content comparisons to proofreading checks against a centralized claims repository that ensures a single source of information across assets.

Material Review Operations and Compliance

We enable customer-centric experiences through digital-first medical affairs operations. Our solutions span across the medical affairs operations spectrum from content creation, medical information (MI), material review and scientific publications to medical science liaisons (MSLs) and learning and development. We personalize customer experiences through strategy, setup and end-to-end management of global and local technology-based MI as well as coordination of scientific publication across multiple therapeutic areas and languages. We apply technology to automate and modularize content creation and review, manage queries intelligently, personalize scientific exchange with physicians and develop self-service interfaces like live chatbots and MI web platforms.

Medical Information and Communication

We reduce the Total Cost of Safety operations by leveraging technology across the case processing cycle to automate high-volume case intake, data processing, quality checks, and medical review for submissions to health authorities, and therefore move from high-touch to low-touch case processing. We monitor, analyze, and report adverse event signals effectively to manage risks across the product life cycle and ensure persistent regulatory compliance. Our team has deep expertise in life sciences risk management and an understanding of global safety practices to support your safety operations with seamless content collaboration, timely availability of high-quality submission-ready aggregate reports, provide insights from operations, risk evaluation and mitigation strategies.

Safety and Pharmacovigilance

Our deep understanding of value perceptions of patients, providers, payers and physicians and rigor in primary and secondary research helps you optimize your pricing, reimbursement and market access strategies with data-driven insights. We have proprietary payer panels in both the US and Ex-US core markets consisting of current and former members of committees responsible for assessing clinical and economic value of therapies.We bring in expertise to help develop the right contracting strategies, creating Target Product Profiles (TPP), payer communication, supporting Health Technology Assessment (HTA) submissions and gross-to-net pricing.

Pricing and Market Access

We author, edit and review regulatory, scientific and educational content for health authorities, HCPs and patients. Indegene’s medical writing team is comprised of physicians, PhDs and life sciences experts who produce submission-ready content of high quality, accuracy, clarity and consistency. Leveraging AI/ML, we streamline content creation, analysis and review, enhancing overall quality and efficiency.Our commitment to excellence is bolstered by the recent acquisition of <a href='https://www.trilogywriting.com/' style='color: #043ea2' target='_blank'>Trilogy Writing & Consulting GmbH (Trilogy)</a>, a company with over 22 years of experience providing medical writing services to the biopharmaceutical and medical devices industry. Combining Trilogy’s in-depth expertise with Indegene’s core capabilities, life sciences companies will benefit from partnering with a single service provider to deliver effective medical writing practices and outcomes at scale across the value chain.

Medical Writing

We apply domain expertise and fit-for-purpose technology to regulatory intelligence and planning, content authoring, dossier compilation and publishing, Health Authority (HA) submissions and query management to improve compliance in a time-intensive, dynamic regulatory landscape. Our team of experienced regulatory professionals continuously evaluates the impact of changing legislation related to product development, registration and approval processes. Our proprietary regulatory intelligence, submission planning and HA query management tools centrally track regulations, dynamically plan and prioritize submissions and predict potential queries from health authorities, enabling efficient and faster regulatory approvals. We also enable end-to-end label life cycle management, and artwork support right from content development, competitor label intelligence, label comparisons, local compliance, and variations management, throughout the life cycle of the product ensuing 100% regulatory compliance, consistency and efficiency in the complex global labeling processes for organizations.

Regulatory Affairs

We provide consulting and technology-led acceleration for learning and development requirements, to enhance business outcomes through custom-developed learning programs. We conceptualize, design, and develop smart and agile learning and development programs that align to the business goals of the enterprise. The curriculums are designed with a thorough skill gap and need analysis, and align to learning pedagogies and strategies. We deliver the programs with a data-driven approach that uses technology to propel change management, peer learning strategies, adaptive micro-learning, and analytics-based learning experiences, alongside continuous measurement of learning effectiveness and ROI. Our proprietary technology uses innovative learning techniques like spaced learning and confidence-based assessments that help gauge the knowledge and confidence levels of the users in a gamified manner resulting in increased learning retention.

Learning and Development

We reduce ambiguities and enable data-driven decisions with HEOR services including effectiveness studies, real-world data (RWD) collection, evidence generation, advanced health economic modeling and value communication. Our multidisciplinary team of clinicians, data scientists, statisticians and health economists enable healthcare enterprises to assess the impact of products on the quality of patient lives and physicians’ knowledge, as well as on organizational budgets and returns on investment. We bring together deep domain expertise, mature processes and proprietary NLP/ML clinical and statistical algorithms to generate RWE from primary and secondary real-world patient data and perform effectiveness studies to enable informed market strategy.

Health Economics and Outcomes Research (HEOR)

Digital Medical Equivalence leverages data, analytics and deep therapy area knowledge to enable market shaping and development processes for medical affairs functions. It analyzes scientific and medical communication interactions with millions of physicians and patients to derive insights that can inform decisions for relevant and personalized information to physicians and patients at a fraction of the cost. It understands medical interactions at the individual level and aligns those behaviors to an omnichannel strategic plan for a future ready medical affairs operation.