ORGANIZATIONAL COLLABORATION

Drug research and development has evolved to become a complex process with multiple research sites and partner organizations requiring seamless and rapid flow of information.

We can help your company develop and maintain highly interactive knowledge portals for employees and partners. We also deliver collaboration solutions with integrated messaging and document management capability for effective distribution of organizational information.

Our Solutions: Knowledge Portals | Instant Messaging | Partner Collaboration

PHARMACOVIGILANCE APPLICATION SUPPORT

The global operating models of pharmacovigilance applications and recurrent regulatory audits have resulted in ever-increasing support and maintenance overheads.

At Ishi, we have developed an offshore model which guarantees 24/7 support for your company’s critical safety applications while our understanding of the regulatory complexities ensure that your applications are compliant with FDA guidelines.

Our Solutions: Level 1 Level 2 Level 3 Production Support

ARCHITECTURAL SERVICES FOR PHARMACOVIGILANCE

Legacy processes and safety systems hinder Life Sciences Organizations from practicing proactive pharmacovigilance. Increase in the number of compounds and resulting caseloads in addition to a diminishing budget results in an unsustainable business model.

At Ishi, we evaluate your existing processes and technology platforms to ensure business and technology alignment. Our proven methodology helps you transition to an ecient architectural platform to offset pharmacovigilance challenges.

Our Solutions: Safety System Architectural Evaluation | Architectural Transition Process | Business Process & Technology Assessments

SAFETY DATA SOLUTIONS

In large Life Science Organizations, it is critical for safety data to be readily accessible for regulatory reporting and managing risk. However, dynamic industry conditions such as mergers and outsourced research have hindered the creation of a consistent safety data model thereby increasing the cost of regulatory compliance.

Our safety data solutions ensure that there is a single repository for Individual Case Safety Report (ICSR) data and a centralized safety data warehouse, coupled with a strong platform for reporting and analytics.

Our Solutions: Master Safety Data Warehouse | Safety Data Integration | Data Migration | Regulatory Reporting

PHARMACOVIGILANCE PROCESS OPTIMIZATION

Process ineffciencies in drug safety and pharmacovigilance are affecting the already burgeoning costs of drug development. The proliferation of work flow systems to manage ICSRs has further complicated the issue.

We help implement process optimization strategies that enable Life Sciences organizations to reduce manual entry points for ICSRs before they reach the medical review stage. By introducing a centralized work flow system, your company can improve efficiency while reducing the cost of case processing.

Our Solutions: Business Process Management | Application Integration | Service Oriented Architecture