PV-MI Integration Improves Case Processing Efficiency: Case Study Overview
APCER Life Sciences played a pivotal role in supporting a US-based pharmaceutical company by integrating pharmacovigilance and medical information services (PV-MI Integration) to enhance case processing efficiency.
The company faced challenges in managing deadlines, handling large volumes of case processing, poor coordination between pharmacovigilance and medical information teams, and regulatory non-compliance. Additionally, recent and upcoming acquisitions and new approvals significantly increased volume of cases.
APCER’s integrated pharmacovigilance and medical information teams provided robust support by efficiently addressing challenges and managing volume surges. With pre-analysis and established bench strength, APCER ensured smooth volume management. The PV/MI integration centralized data management, optimizing costs related to staffing, technology, and training.
This integration facilitated the seamless transfer of information between the two teams, enabling the early identification of potential safety concerns and allowing for proactive risk management strategies.
Impact of Integrated PV and MI Capabilities on Case Processing Efficiency: Highlights
For Comprehensive, Integrated Pharmacovigilance and Medical Information, the following steps were taken:
- Innovative, Integrated Governance Mechanism: A 6-month pilot with APCER was launched to ensure business continuity and evaluate service quality for new products.
- Unified Quality Management System (QMS): The proposal exceeded standard service solution, introducing a novel, unified governance approach for holistic PV and MI systems management.
- Strategic 6-Month Pilot Program: A unified QMS was proposed to eliminate redundancies, streamline operations, and enhance case processing efficiency.
APCER’s Integrated PV-MI Capabilities
- APCER’s team consists of highly qualified healthcare professionals with muti-therapeutic expertise in PV and MI.
- The team has expertise in managing expansive portfolio coverage for various product types, utilizing fully integrated and validated technologies
- Globally located Integrated response centers can manage overflows or spikes with MI coverage in 50+ languages and 24×7×365 coverage across all time zones.
- Efficient Project Management with unique “two-in-a-box model” ensured timely execution of deliverables.
- A flexible, scalable team model with customizable Adverse Event (AE), Product quality complaint (PQC), Quality Assurance (QA), and content management modules.