Services

OVERVIEW

We at Expedient measure success by the success of our clients. We offer an array of solutions pertaining to the industries we deal with, aiming to solve any foreseeable challenges. We focus on bridging the inter dependencies that exist between clinical, regulatory and safety systems. We align our solutions with our client’s business processes and compliance objectives focusing on resolution of issues ranging from clinical to post-marketing safety and risk management.

Safety Database Services

We are skilled in the intricacies of Argus/Argus J and ARISg and corresponding data mart and business intelligence tools including Argus Insight, Argus Mart, Cognos™, OBIEE and Business Objects.

    We Assist With:

    • Implementation and upgrades of safety databases
    • Requirements and design of the infrastructure for premise based systems (alternatively, we can host your system and/or your development environments)
    • Design the configuration for the new system
    • Implementation of E2B R2 and E2B R3 reporting and import to/from health authorities and license partners
    • Implementation data marts as well as custom reports (in English and Japanese)
    • Performing any necessary data migration(s) from global and/or Japanese legacy systems
    • Provide business transition and change management services to ensure a successful implementation. We work with your business leaders to develop the new business process and workflow
    • Identify SOPs that need to be created or updated and update/author SOPs as required
    • Assist with development and delivery of training to your safety, business and IT organizations
    • We provide complete validation services ranging from end to end validation activities to script authoring and execution. We also write user requirements (URS), functional requirements (FRS) and all other CSV deliverables per your QA standards (e.g., IQ, OQ, PQ, VSR, trace matrix)

    DATA MIGRATION

    Expedient carries the experience of performing successful data migrations from each of the major global and Japanese safety systems – including Oracle AERS, Clintrace, Empirca Trace, ARISg, ARISj, Perceive, H-P Clinical Works, Custom and Argus into Argus, Argus J, ARISg and Oracle AERS.

     

    Expedient’s Approach To Data Migration:

    • Analyze the destination and source databases to determine the best migration approach and to identify data quality issues
    • Define the business rules for the data migration in close collaboration with the end user community
    • When migrating from both global and Japanese sources, we employ a master data principle to govern how duplicate cases are merged
    • Emphasize consistency and integrity during transformation code development
    • Collaborate with business users to decide the mappings
    • Perform data mapping between safety databases to reveal issues that need to be resolved
    • Provide business transition and change management services to ensure a successful implementation. We work with your business leaders to develop the new business process and workflow
    • Identify SOPs that need to be created or updated and update/author SOPs as required
    • Assist with development and delivery of training to your safety, business and IT organizations
    • We provide complete validation services ranging from end to end validation activities to script authoring and execution. We also write user requirements (URS), functional requirements (FRS) and all other CSV deliverables per your QA standards (e.g., IQ, OQ, PQ, VSR, trace matrix)

    BUSINESS TRANSFORMATION

    Business Transformation (BT) integrates key aspects of your project to deliver successful change.

    Expedient’s business transition methodology supports a company in its quest to become a best drug safety organization. We have a proven methodology to analyse, design, harmonize and optimize PV processes, assess the impact of changes to existing SOPs and then assist with creating or modifying SOPs to match the new process. We then assess training requirements, develop the training curriculum, create training materials and deliver training worldwide.

     

    There are multiple business reasons that drive the need to redesign PV business processes such as :

    • New products or growth of existing products which result in higher case volumes and/or PV operations in new regions
    • Mergers and acquisitions
    • Merging PV operations
    • Consolidating PV operations across divisions
    • Launch of your company’s first product — or preparation for approval of the first product

    PV Operations Merger

    PV operations mergers are usually the direct result of a merger or acquisition. Often times the PV department and systems of the acquired company are merged into the parent company’s PV organization. Sometimes the acquired company is left to operate standalone for several years and then consolidated or different divisions are left to run alone initially and then are consolidated. To consolidate PV operations the existing systems must be merged via data migration(s) into a single safety system and the business processes and operations must also be merged.

    Depending on the maturity and efficiency of the parent company’s existing (‘As Is’) PV process, the process are harmonized into the existing process or they must be redesigned or substantially optimized in addition to being harmonized. Expedient rapidly assesses the ‘As Is’ process of each entity / organization and then conducts workshops to define the ‘To Be’ process, document it and gain agreement across all key stakeholders.

    Merging Global and Japan PV operations uses the same techniques, but requires a mix of Global and Japan business resources to properly handle language, cultural, time zone and regulatory concerns.

    SOPs must be assessed to determine the impact due to process changes and then must be updated. Expedient performs the assessment and then assists in creating or modifying all SOPs for Global. Affiliates, licenses partners, etc. are also impacted by the merger. Some affiliates must be consolidated, the controlling entity for PV changes in many instances and appropriate steps must be performed in each region for contracts and license partners, resource requirements may change for some affiliates due to a change in safety systems, etc.

    Root Cause Analysis And Process Optimization

    Often times organizations gradually outgrow their existing process and need to optimize the process. The existing process works, but the cost of compliance is high. Expedient specializes in identifying root causes of compliance issues and creating and implementing CAPA. In addition, we have a proven methodology and approach for optimizing PV business processes to reduce hand-offs and eliminate rework loops — and automate to the extent possible taking advantage of safety system features, case intake solutions, etc..

    Process Design / New PV Operation

    Expedient can assist with defining the PV processes and creating the SOPs required to setup a new drug safety operation. We have a pre-existing set of best practice PV SOPs, business processes and system workflows for small to medium sized businesses and we also provide hosted safety systems that can be implemented in as little as 90 days.

     

    COMPUTER SYSTEM VALIDATION SERVICES

    Expedient’s Computer System Validation (CSV) team has significant experience and is a preferred choice for many global pharmaceutical organizations in supporting their application related validation and change management regulatory requirements. Our CSV experts help in analysis, design, execute and manage validation requirements as per the FDA, EU and various global compliance requirements.

    We Provide Below Services As Part Of Our Computer System Validation Practice :

    • End to End Validation service – For any GxP application being implemented, developed or upgraded – complete end to end validation activities starting from requirement gathering, development of validation plans, IQ, IQ, PQ deliverables to validation summary report. Expedient provides standard templates, standard operating procedures and processes as well developed in compliance with various regulations.
    • Gap Assessment / Periodic review – For existing GxP applications, a periodic review / gap assessment shall be performed to ensure the application is in validated state.
    • 21 CFR Part 11 Assessment – A complete assessment of applications against 21 CFR Part 11 to ensure ERES compliance.
    • Validation Testing – Expedient provides functional resources to execute / support validation testing and ensure collection of objective evidence adhering to good testing and documentation practices.

    IT INFRASTRUCTURE QUALIFICATION

    Expedient IT has experience in qualifying client’s infrastructure for deployment of IT systems. Our experts have a competent understanding of the unique Life Science system vertical requirements.

    • IT Infrastructure Qualification : We qualify infrastructure based on the existing infrastructure requirements of the computer systems in use.
    • Data Center Audits : Facilities need an effective data center management system to integrate the process requirements in a smooth archiving & backup solution.

    Development of procedures and establishing streamlined policies for infrastructure.

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