ie-message

PHARMACOVIGILANCE AND DRUG SAFETY

INDEGENE INTELLIGENT SAFETY SUITE

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.

Significant increase in adverse event (AE) reporting, higher media scrutiny, and stringent and ever-changing regulatory requirements are currently posing challenges to the pharma industry. Furthermore, pharmaceutical organizations are also grappling with compliance and quality requirements, stringent timelines, and increasing costs. Keeping in view the above factors, we have deeply invested in contemporary technologies of Artificial Intelligence (AI) and automation to transform traditional pharmacovigilance (PV) processes and enable pharma companies to increase case accuracy quality and compliance, reduce time to regulators, and drive productivity and efficiencies in PV operations while significantly reducing costs.

Indegene's Product Safety and PV solutions include medical contact centers, data entry and case processing, quality and medical review, literature and social media monitoring, aggregate safety reporting, signal detection and risk management, and consulting and training, and are significantly enhanced by Indegene's Intelligent Safety Suite, our transformational modern technology solution contextualized to life sciences through deep safety expertise.

Powered by Indegene's Intelligent Safety Suite, over 50% of the work is done by machines which instantaneously perform their tasks. Thus, instead of traditional outsourcing, we “machine-source” work and this 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.

Our differentiation lies in exclusive focus on the life sciences industry and a proven track record of partnerships by seamlessly integrating medical expertise, operational flexibility, technology know-how, and advanced analytics in PV and drug safety.

  • 100% focus on the life sciences industry with deep domain expertise and regulatory understanding

  • Well-established safety practices

  • Our AI-enabled Intelligent Safety Suite

  • Scalable team of professionals with deep scientific/medical expertise and experience

  • Global operating model built on industry's best practices to deliver service excellence by ensuring global compliance, standardization, and cost-effectiveness

  • Ability to provide 24×7 support by working across time zones for seamless support

  • Investments in transformational platforms and solutions for scale, compliance, and efficiency

Key Outcomes

By deploying a team of highly skilled, experienced, and result-oriented experts who bring a blend of extensive PV and medical writing experience, scientific expertise, domain knowledge, and execution excellence ensures a complete coverage of business needs with a disciplined approach for rollout.

We have a large talent pool of life sciences postgraduates and healthcare professionals who are trained and experienced in PV and product safety and have extensive knowledge of various therapy areas and regulatory requirements. We have MDs and PhDs with in-depth medical and therapy area knowledge to perform medical reviews and safety assessments. Our competent multidisciplinary team consists of safety associates, operations managers, medical writers, quality experts, certified MedDRA coders, safety physicians, and subject matter experts. Indegene invests immensely on continuous training and learning by participating in conferences, FDA/EMA-conducted webinars, as well as internal trainings by experts on latest regulations and industry updates:

  • Extensive knowledge on drug development process, product safety, and regulations/guideline (ICH, GVP modules, CIOMS, 21 CFR 314, etc.)

  • Expertise in various safety databases, dictionaries, and signal detection tools

  • Specialized team focused on literature search for various PV activities using different global and local search engines, journals, and websites

  • Excellent writing and analytical orientation with ability to manage simple-complex documents with good coordination and project management skills

  • Access to a team of experienced therapeutic area, key opinion leaders, and subject matter experts across our service delivery centers in India and overseas

Indegene has invested in building its own state-of-the-art Indegene Learning and Development Academy (iAcademy) which trains and develops experts on general and specific topics of Global Regulatory, Safety, and PV curriculum. Indegene also provides exposure to its people to continuous learning opportunities by enabling them to take up affiliated global certification courses, attend regulatory and PV conferences and expert speaker sessions, and so on.

Indegene works with its clients to ensure quality plans developed are tailored to each engagement with defined parameters and supported by process checklists, work instructions, and tip sheets. The 360° feedback mechanism ensures appropriate flow of communication between the stakeholders with a well-defined escalation plan. The knowledge gathered through the global forums is stored in a centralized enterprise knowledge management repository that can be accessed to ensure best practices, knowledge frameworks, and guidance are followed for all our engagements, thereby providing enormous benefits to our clients.

Indegene is an ISO 27001:2016 (Information Security Management System) and ISO 9001:2015 (Quality Management System)-certified organization. Indegene has well-defined and best-in-class program/project management practices certified CMMi Level 3 for services, which helps us deliver projects more efficiently in terms of quality and timelines, thereby driving high client satisfactions. A robust quality culture is established and practiced across our PV teams. Our process and quality management plan is compliant with the ICH E2B, GVP, and FDA specifications. With ISO-based and CMMi-based quality (services) frameworks, both process quality assurance and product/service quality control are ensured across all customer engagements.

Indegene's Intelligent Safety Suite

We have 24×7 multilingual call centers supporting the US and EU regions from India and other regions depending on the client requirement for AE reporting, product complaints, and MI.

Indegene PV experts are experienced in end-to-end single-case processing solutions for clinical trials, spontaneous/post-marketing, and legal cases. It includes case intake, data entry, narrative writing, quality review, medical review, and distribution of ICSRs. Indegene’s team of PV resources has extensive experience working on a number of well-known safety databases.

We provide standalone QC and QA services. Our QC solutions include 100% in-line QC review for accuracy and consistency of cases processed by incumbent vendors and additional sample QC review to improve case quality. QA solutions include SOP and timeline compliance review, verification of case entry against the source, and verification of case receipt and creation date. We also perform RCAs and support in CAPA preparation and implementation.

Our NexGen integrated, customizable, scalable PV/drug safety solution is cloud-based, secured, ready-to-deploy, and intuitive centralized case intake hub that is easy to integrate with existing infrastructure and safety databases with status tracking and prioritization of cases. Along with workflow management, our solution enables dashboarding and reporting for centralized resource management and efficiency optimization.

We integrate multiple data sources such as call centers, clinical trials, License Partners, Health Authorities (HAs), literature, and social media in various formats like forms, E2Bs, spreadsheets, emails, fax, scanned copies, and other semi-structured/unstructured formats with the ability to integrate with new-age data sources such as RWD/EMR/claims, and mobile apps. There are significant efficiencies in case management due to auto-extraction of AE information from sources, validity assessments, duplicate check, triage and prioritization, auto-coding, and quality check. The E2B XML generated from our platform can be auto-imported to any safety database for final medical review and submission to Health Authorities

Indegene has experience in global and local literature search including literature search strategy design, setting up alerts for daily and weekly screening, and journal retrieval, search, and management workflow. Indegene has expertise in reviewing citations/abstracts and full publications for minimum ICSR criteria, for aggregate reporting and signal detection. With our literature review tool, we have automated sourcing of literature articles from databases with the ability to define and manage multiple search strategies such as AI-driven literature article categorization and deduplication technologies and NLP-based search.

We provide technology-enabled social media monitoring services to detect AE/PQC, NLP-based data collection, AI-based extraction of product and related information from the blogs, discussion forums, patient engagement portal, social networking sites, news, and others.

Indegene's aggregate reporting and safety documents authoring team comprises extensively experienced medical writers and healthcare professionals with deep medical knowledge and good understanding of global regulatory/safety practices. We have a successful track record of providing end-to-end support from managing global reporting calendar, sending for call for contributions and coordinating with contributors, authoring, medical and quality review, formatting and submission readiness for a range of documents including Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Reports, Addendum Clinical Overviews, safety narratives, Health Hazard Assessment reports, safety assessment reports, labeling justification documents, and others:

  • Authoring of various aggregate reports across type of products and therapy area

  • Call for contribution and coordination with multiple stakeholders

  • Document management and coordination throughout the report life cycle

  • Targeted literature search/screening for safety assessments, benefit-risk analysis

  • Benefit-risk assessment, safety profile assessment, and medical assessment

  • Quality review of aggregate reports

  • Evaluation and medical analysis of potential safety signals

  • Final compilation of reports to ensure submission readiness

We combine deep medical knowledge and NLU and NLP to automate many parts of authoring, thus greatly simplifying the process and efforts involved in authoring and analysis of such documents

Safety Surveillance and Signal Detection: Indegene has extensive medical expertise and sophisticated big-data analytics capabilities to offer services across signal identification, evaluation, categorization of identified and potential risk, and identifying needs for specific data collection. This solution combines evidence-based statistical results, with experience-based physician monitoring to help decipher a drug’s clinical behavior and detect signals related to its safety and interactions with other factors. Indegene has extensive data-mining expertise across FDA AERS, clinical trials, and other datasets and time series analysis, along with automated analyses for aggregate data review for heightened surveillance products with open signals. Specialized analytics, customized thresholds, trending, workflow, as well as built-in comparison engines (risk groups, time period, drug, etc.) provide a robust product-specific signaling and surveillance framework to our clients, which may include:

  • Signal detection from various sources – PV safety database, regulatory database, LPs, company studies, published and unpublished medical literature, preclinical studies, product complaint information, and so on

  • Line-listings assessment from the safety database for D-E pair analysis

  • Detection, prioritization, validation, and evaluation of safety signals using qualitative and quantitative methods and algorithms for routine and heightened surveillance (PRR, ROR, Chi-square, Bayesian methods of statistical analysis, etc.)

  • Signal report preparation for signal review committee

  • Additional monitoring tracker and recommendations

  • Development of signal management SOPs, WIs, process flow, and other process documents

Risk Management Solutions: Indegene offers comprehensive solution from assessment and identification of risks to development of strategies for risk reduction and implementation of risk management plan (RMP). Our risk management experts have in-depth understanding of regulatory changes and global HA requirements for risk evaluation and mitigation strategies.

Our core capabilities include:

  • Updating and authoring of core and local RMPs (generic, hybrid, biosimilar, and innovator products)

  • Benefit-risk assessment, safety profile assessment, and medical assessment

  • Risk mitigation and management strategies (proactive signal evaluation; selection of valid and measurable outcomes; identify appropriate data sources, and time intervals for surveillance)

  • REMS Medication Guides and development of educational materials/questionnaires as additional risk minimization measures

  • Communication tools and development plan as part of REMS

  • Elements to assure safe use (ETASU) development, implementation, and management

  • Targeted literature search/screening for safety assessments and benefit-risk analysis

  • Preparation of RMP Annex-1, preparation of RMP-tracked changes version, and transposition of old RMP to new RMP template

Once again, by combining strong knowledge of REMS and technology capabilities, our REMS platform offers clients the ability to completely outsource end-to-end management of REMS programs.

Our services include medical assessment, causality assessment, serious unexpected safety adverse reaction assessment, SAE reconciliation, periodic review of aggregate data from PV safety database, review of narratives for medical concept, and data mining in different safety databases as well as epidemiology literature review:

  • Provide safety input and review of product labeling updates; prepare labeling justification documents

  • Responding to HA and LPs queries

  • Set up PV agreements/SDEAs

  • License partner's compliance monitoring

  • xEVMPD support for maintaining products on EV database

  • Preparation of DHCP communications

  • Medical assessments/health hazard assessment for product complaints

  • Clinical trial-related safety activities – provide inputs and review of study protocol, study report, IBs, development RMPs, SAE reconciliation

  • License renewals and authoring clinical summaries, ISS, and nonclinical safety reports

Indegene has a network of experts across the United States, Europe, and Middle East-North Africa region to provide highly focused solutions from translational medicine to development and life cycle management of a product. The range of solutions includes drug development RMP, safety management plan, inspection-ready activities, Drug Safety Management Board, preparation for scientific advice and end of phase-II meetings, scientific advice on biomarkers and drug safety, managing safety questions from agency, defining post-licensing commitments, planning risk mitigation strategy, Qualified Person for Pharmacovigilance (QPPV) services to marketing authorization holders, managing safety data exchange agreements with licensing partners, post-authorisation safety study, and post-licensing study.

Key Outcomes

Key Performance Indicators

Key Outcomes

Key Performance Indicators

Key Performance Indicators
Quality

We consistently have been able to deliver quality of more than 99% for case processing and <0.5 errors per page for document authoring. Our singular focus is on getting our reviews “Right First Time.”

Timelines

We have been able to consistently maintain the timelines at 100% year on year for case processing and for regulatory submissions. We have been able to achieve this as a result of a robust quality review and workflow tracking process, which enable us to deliver quality first-time documents and also helps us track and mitigate any risk toward the submission of the documents to the regulatory authority.

Key Performance Indicators
Key Performance Indicators
Productivity
Productivity

Our Intelligent Safety Suite is a unique offering which allows us to significantly automate and improve compliance and turnaround time for cases. This along with continuous improvement initiatives have led to boosting productivity gains for many of our customers by over 60%. Apart from automation, we have been able to achieve this as a result of continuous and nuanced training to our review specialists, deployment of trained subject matter experts, centralizing the operations of review processes, and contextualizing modern technologies to automate an increasingly significant portion of the review processes.

Compliance

We have maintained a track record of 100% compliance on all our engagements not only for operational delivery but also for client training and process requirements. Our specialists have knowledge of global and regional regulations and guidelines. Our specialists are regularly and continuously trained on ever-changing regulatory policies. We also engage closely with key personnel who are or have been involved in constituting regulatory guidelines.

Indegene has exceeded its client expectations through maintaining high-quality delivery as evident from zero critical findings in the audit and vendor assessments.

Compliance
Compliance

AI in the medical domain: not a quick fix

Modernizing case intake

Modernizing case processing

Indegene Safety Solutions

Indegene's AI/NLP Powered Pharmacovigilance/Safety Solution

Real world case study

Indegene literature review solutions

Risk management and signal detection solutions

Indegene safety authoring solutions

The Panorama of Safety Agreements