Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- Focus on patient centricity, increased regulatory scrutiny, the emergence of complex diseases, and the need for next gen-treatment methodologies, are some of the key trends the pharmacovigilance (PV) space is witnessing.
- Pharma companies must focus on harmonizing global and local PV functions, addressing interoperability issues, and rationalizing siloed processes.
- Evident is a shift toward a more proactive, resilient, and PV insight-driven future, one where patient safety is not just preserved but elevated through digital precision including aggregate reports and other safety reports.
- We identify and implement continuous improvements and develop efficient, scalable, and cost-effective strategies.
In this article
Overview
The pharma industry constantly aims to meet regulatory compliance to accelerate the delivery of life-changing medicines to patients.
The industry faces varied challenges, including adverse event (AE) volume management, complying with evolving regulations, and associated implementations while rationalizing costs. Besides, developing novel drugs such as monoclonal antibodies (mAbs), RNA vaccines, and combination products calls for high safety scrutiny.
Increased awareness and knowledge are needed to evaluate real-world evidence (RWE) sources for signals and safety information. From a tools and technology perspective, the challenge is finding efficient and cost-effective cognitive solutions.
Pharma companies have often expressed the need for scalable and flexible PV operations, harmonized global and local PV functions, breaking down silos between systems and processes, and resolving data interoperability issues.
Our solution
Our PV services help pharma companies ensure regulatory compliance and enhance quality and efficiency at a reduced cost.
We have established a value-focused metrics framework.
The focus areas of the TCS Pharmacovigilance Services portfolio include:
- Managing end-to-end individual case safety reports (ICSR), literature surveillance, regulatory intelligence, aggregate writing, signal detection and management, medical safety, and risk management
- Delivering local affiliate activities (local case intake, local submissions, local literature, local follow-up), PV analytics, and applications
- Working closely with our customers for SOP management, Pharmacovigilance system master file (PSMF) maintenance, safety data exchange agreement (SDEA), learning management, MedDRA update support, Extended EudraVigilance medicinal product dictionary (XEVMPD) support, and compliance management.
Figure 1: Combining deep PV domain capabilities with cognitive automation and AI
We adopt the following approaches to ensure regulatory compliance –
Domain approach: Our flexible, scalable, and knowledge-enriched PV operations harmonize global (ISO IDMP, RMP, electronic submissions) and local PV functions. Our consultants keep abreast with evolving regulations (ICH E2B-R3, EU CTR, GVP VI-Rev 3) and engage with customers to develop innovative tools, approaches, and strategies. With their thorough knowledge of the product and disease, our PV professionals focus on quality and compliance, and our teams are always audit-inspection-ready.
Automation approach: Our AI-enabled PV services facilitate automated safety data collection directly from patients, physicians, and social information channels such as mobile apps, websites, and call centers. We provide automations across ICSR steps including validation and duplication checks, data entry, medical coding, case assessment, seriousness, causality, and listedness. Our PV tools generate automated narratives, provide predictive analytics, and monitor signal detection too.
Benefits
We offer PV services for life-changing medicines that create long-lasting value for patients and society.
We provide continuous support in safety evaluations for revolutionary medicines—gene therapy, cell therapy, pharmacogenomics, real-world data, and digitized clinical trials—with a vision for a healthier world for everyone.
Key benefits include:
- Consulting on new and comprehensive approaches, operating models, and technologies in PV
- Employing predictive PV—using data analytics, signal monitoring, and risk identification—for faster risk identification evaluations
- Ensuring high compliance with regulatory submissions
- Defining customer processes and regulatory guidance documents
- Devising global location strategy for country-specific requirements and robust business continuity planning
THE STORY IN NUMBERS
The TCS advantage
TCS has been regarded as the industry leader in providing pharmacovigilance services by several market data analysts.
Since over two decades, our strategic and long-standing PV partnerships have expanded to niche PV services, and we added new delivery locations and new talent. Our expertise in the PV domain and medico-scientific acumen, coupled with the successful deployment of an AI-ML-based cognitive platform, has won the trust of leading pharma companies.
We offer the following differentiators:
- Our PV services have been inspected, audited, and accredited by worldwide regulatory health authorities with a proven track record of zero critical findings
- Our Pharma Academy of Learning and Sharing (PALS) team has created robust training modules
- Our multi-location delivery model offers cost-effectiveness and excellent time zone coverage so you always meet the regulatory timelines
How we helped our customers
The end-to-end PV transformation journey of a large UK-based pharma company
Multiple hand-offs at customer's regional centers led to delays and high oversight. The customer needed a different approach to manage large case volumes with high quality and 100% compliance.
We helped the customer merge its fragmented and disparate processes across various regional centers, achieve 100% ICSR delivery, identify gaps and streamline training, and reduce the need for process supervision. We consolidated the customer’s seven regional centers into three regions by charting a global unification strategy and updating the customer’s relevant SOPs and guidelines.
Our PV services enabled the customer to achieve the following:
- Synergistic PV operations and harmonized global processes in ICSR
- Streamlined processes pertaining to aggregate reports, safety surveillance, and signal detection
- High quality and regulatory compliance owing to the implementation of industry-benchmarked SLAs and KPIs
In conjunction with our PV domain services, the adoption of the TCS ADD™ Safety platform led to significant efficiency gains for ICSR intake and case processing steps. We also engaged with the customer’s teams to offer functional consulting for new signal system development and implementation.
A large UK-based pharma customer required highly experienced physicians (including medical review)
We deployed experienced safety physicians to support early-development and post-marketed products. Major activities included reviews and/or authoring of signal evaluations, preparations of signal evaluation reports, medical evaluations of ICSRs from clinical trials (SUSARs), line listing preparations, aggregate analyses, analysis of similar events, investigator, investigational new drug safety reports (INDSR) notifications, signal management team (SMT), signal review team (SRT) reviews, aggregate reports, risk management plan (RMP) reviews, participate in label committee meetings for potential label changes, preparation of health authority responses, benefit-risk evaluations and support to cross-functional teams in clinical and regulatory activities.
These safety physicians act as clinical trial safety physicians as well and review study protocols, investigator brochures (IBs), electronic case report forms (eCRFs), clinical development plans, clinical study reports (CSRs), and health authority (HA) submissions. This team works closely with the ICSR medical review team.
Once the project started, our physicians required minimal to no supervision. Medico-scientific knowledge exchange and high collaboration between our safety physicians and customers’ physicians for product safety enabled faster evaluations and timely decision-making.
