Over the past decade, Indegene has partnered with R&D, Clinical, Safety, Regulatory, and Medical Affairs functions in life sciences companies to industrialize several large business processes such as clinical trial operations, clinical data management, safety case intake and processing, medical writing, and several similar business functions to standardize processes and drive efficiencies. Indegene has also successfully industrialized more specialized functions such as product labeling and artwork, medical information, medico-legal review of promotional/non-promotional assets, and some complex Regulatory/Safety/Clinical/Medical business processes.
With deep medical expertise, clinical understanding, regulatory knowledge, and processes established at industrial scale, while Indegene has partnered life sciences organizations, we are now leveraging life sciences-contextualized current technologies (artificial intelligence [AI], natural language processing [NLP], and machine learning [ML]) to modernize the R&D and Medical business functions of life sciences companies worldwide.
Bringing deep expertise and life sciences-contextualized technologies together, we have been demonstrating differentiated outcomes such as reduced compliance risk, enhanced accuracies and consistency, reduced time-to-agency, increased speed-to-market, and increased efficiencies.
Some of our approaches enabling life sciences companies transform and modernize their Regulatory, Clinical, Safety, and Medical Affairs business processes are Indegene Intelligent Content Management and a number of AI-led sensible automations with impact across business functions.
Indegene's industry-leading proprietary Intelligent Content Management leverages AI/ML/NLP to auto-create and update large numbers of medical documents across R&D, Clinical, Safety, Regulatory, Medical, and Commercial areas.
Indegene’s approach provides the ability to deconstruct unstructured/structured content into components, identify content lineages between source and derivative documents, and automate content authoring/updates in a modular and scalable manner to achieve highly differentiated outcomes for the industry.
For content creators, the ability to convert documents into structured data within a business-appropriate taxonomy is critical in bringing automation and intelligence into content authoring.
For content consumers, the ability to convert documents into structured data drives improved search, retrieval, and reuse of content compared with existing structured content authoring or robotic process automation methodologies that are limited by their rule-based foundations.
Indegene Intelligent Content Management contextualizes best-of-breed modern technologies with deep medical expertise and learns continuously and autonomously, allowing it to handle even the most nuanced medical content use cases, unlike structured content authoring or robotic process automation solutions that are limited by their rule-based foundations.
Indegene's AI-enabled Intelligent Safety Suite provides end-to-end automated PV solutions for AE/PQC case intake, case processing, literature and social media monitoring, signal management, authoring safety documents, RMPs, and REMS. Our next-generation integrated PV/drug safety solutions help pharma companies achieve 100% compliance, >99% quality, and 50%-75% reduction in manual efforts with 40%-70% cost savings.
|1||Voice to Text||Speech-to-text NLP engine for intelligent call-flow assistance ML-driven real-time structured data extraction in predefined templates||MI Call Centre AE and PQC Case Intake|
|2||Unstructured to Structured Conversion||NLP-AI-driven data extraction and data population into structured fields from unstructured/semi-structured sources||Individual Case Safety Report, Clinical Data Management, and Data Entry for client-specific internal processes|
|3||Data and Text Comparison Tool||Rule-based and AI-based text, data, table, and figure comparison||QC review/proofreading of Clinical, Regulatory, Safety, and Medical documents|
|4||Literature Review Tool||Automated and configurable sourcing of literature articles from the databases; define and manage multiple search strategies; AI-driven literature article categorization and deduplication technologies; and NLP-based search||Data sharing and usability across different functional groups – Clinical, Regulatory, Safety, and Medical|
|5||Social Media Monitoring Tool||Technology-enabled social media monitoring, NLP-based data collection, AI-based extraction of product, and related information from the posts||Adverse Event/Product Quality Complaint data collection, sentiment analysis, consumer and prescriber perception, and influencer engagement|
Domain SMEs (Medical Writers/Reviewers/labeling/PV Associates etc.), with extensive experience in domain and operations, ideate opportunities for AI in domain with the technology and strategy team, implement AI-enabled process in operations, and provide continuous feedback to improve AI output.
Therapy Experts, with deep therapy/disease understanding, contribute to the ML process by training for clinical interpretation, medical integrity, and relevance.
Medical Data Scientists, along with advanced understanding of analytical technologies including ML and predictive modeling, bring about in-depth understanding of medical domain to provide insights beyond statistical analysis to business. They provide strategies for implementation activities, lead operations team, and identify new business opportunities in medical-led AI.
Medical Curators, with intermediate-to-advanced understanding of medical technologies and broad domain expertise across Pharmacovigilance, Regulatory & Safety, Medical Writing, and so on, review and guide annotators per project requirements and provide expert opinion to enhance performance of machine.
While traditional medical writing roles continue to remain relevant to the medical content development process, newer skills are now required in the era of current technologies to truly benefit from them.
Increasing efficiencies, enhancing communication, and improving compliance by bringing medical expertise with digital and data-driven models
Full-thickness solution for simplified and faster material review and approval of promotional and non-promotional assets
Next-generation integrated PV/drug safety solutions help pharma companies achieve 100% compliance, >99% quality, and 50%-75% reduction in manual efforts with 40%-70% cost savings
AI-enabled multicountry strategy and execution to drive end-to-end compliance and productivity in product labeling and artwork
Deep regulatory expertise and life sciences-contextualized technologies to modernize regulatory function and processes
Full-thickness global partner in pre- and post-market phases for Clinical, Safety, Regulatory, and Medical Affairs streams
Technology-enabled fully managed solutions to accelerate clinical trial design and life cycle management