Experience

Foresight has completed over 400 projects for small to large pharmaceutical, biotechnology, device, and CRO companies in the US, EU, India, and Japan. Below are examples of projects Foresight has delivered to our customers around the globe.

Business Process Design/Optimization,

Training & SOPs

  • Over 30 Global drug safety process and system assessment and redesigns, PV operations mergers and optimizations
  • Have designed many Global-Japan harmonized processes for processing of cases in a single world wide safety database
  • Created and delivered training for Global and Japan users on safety processes and systems in both English & Japanese
  • Performed multiple SOP assessments and authored SOPs, WIs and Manuals in both English & Japanese
  • Multiple PSUR process design and optimization projects
  • Designed PV quality assurance, root cause analysis, and corrective action planning processes and organization

PV Performance and Compliance Metrics

  • PV Monitor® hosted solution for PV performance and compliance metrics for 5 top 30 companies
  • Outsourced compliance analysis and CAPA services
  • Designed metric reports and feeds from multiple systems, managed in-house implementation via client IT resources
  • Created supporting SOPs and business user training

Industry Benchmark Survey and Analysis

  • Numerous surveys on behalf of clients for clinical and post-marketing safety related practices across peer companies:
    • Global process for investigator notifications
    • SUSAR notification and submission process
    • Impact of data correction, SAE reconciliation and duplicates on submission compliance

Safety Database Implementation

  • Performed over 50 safety database implementations and upgrades for US, EU and Japan headquartered companies
  • Have performed multiple Argus J implementations — and have been selected multiple times to host Argus J in the Foresight® Cloud
  • Have successfully completed over 50 data migrations for as few as 500 cases to over 3 million cases from Argus, ARISg, Clintrace, AERS, ARISj, Perceive, HP Clinical Works and custom databases
  • Validation for Argus/Argus J, ARISg, Clintrace, and AERS implementations.  Have performed English and Japanese validations
  • Have performed MedDRA up versioning multiple times — and routinely as part of hosting and managed services
  • Have developed 100’s of custom reports against Argus and ARISg for many customers and also for Argus J in Japanese

Analytics and Reporting

  • Creation of 100’s of custom reports in both English and Japanese
  • Functional specification for ad hoc, management, and signal detection reports
  • Numerous implementations of data marts for Argus (Argus Insight, Argus Mart) and Aris Global
  • Implementation of custom reports in Business Objects, Cognos and OBIEE
  • Managed services for on-going report development for multiple top 50 companies
  • Foresight® PV Query solution for ad hoc query and analysis

Case Receipt / Intake

  • Implementation of a solution to capture AEs from 60+ countries via a web based solution, verify against business rules
  • Web-based system to automate data entry of ICSRs captured on-line from call centers in US and UK into a custom safety database
  • Implemented an interface for automated capture of potential adverse events from affiliates globally into Argus Affiliate
  • Foresight® PV Intake solution

E2B Reporting

  • 50+ E2B implementations as part of Argus / Argus J implementations
  • Have implemented E2B reporting to the PMDA from Argus J
  • Experts at configuring E2B reporting rules
  • Experts at custom DTD and E2B+ for reporting to license partners and to address issues with out of the box safety database E2B profiles

Drug Safety Outsourcing

  • Analysis and RFP creation for multiple large pharmaceutical companies to evaluate drug safety outsourcing alternatives
  • Analysis and RFP creation for a small biotechnology company
  • Partner with QSI for case processing / BPO services for Foresight® Cloud customers

PV Quality Assurance

  • Implementation of a quality plan, business processes, and an online system to manage PV QA/QC reviews
  • Analysis and redesign of existing QA/QC processes for multiple top 20 companies
  • Provided medical professionals to a large pharmaceutical company to perform quality reviews of legal cases processed by a CRO

Retrospective Analysis for Outcome Coding

  • Led a project to determine the impact of a company’s previous outcome coding policy on the risk profile of the affected products

US Operations Baseline Assessment

  • Reviewed case processing activities of a large affiliate. Within one week, Foresight identified solutions to the following problems:
    • Reuse of case numbers
    • Redundant data entry across call center system, tracking systems, case record forms, and AE system
    • Time consuming and in-effective duplicate search
    • Errors with date stamping source documents
    • Inconsistent use of personal spreadsheets by coordinators and managers to manage and track workflow
    • Untimely follow-up query process

Central Operations Process Improvement

  • Identified process changes to central operations to improve expedited submission compliance:
    • Implemented a point-of-no-return to prevent cases that are in jeopardy of being late from being late Instituted
    • Alert reports to identify current case load of expedited cases, age of cases, and process step for each case
    • Changed the data correction policy to use the date when new information is received appropriately
    • Changed the 15 Day clock to use calendar days even when the 15th day falls on a weekend
    • Changed workflow tools to place greater emphasis on high priority cases

AE Sweep

  •  Created and managed a plan for a global sweep for unreported AEs from vendors, affiliates, partners and sales force
  • Automated sweep of millions of sales records for potential AEs

Global Therapeutic Area Standardization

  • Provided project management support to standardize efficacy instruments by therapeutic area across all clinical trials globally
  • Standardization was comprehensive across CRF design, Statistical Analysis Plans (SAPs), and presentations (tables & figures)
  • Worked with the lead clinicians, statisticians, and SAP developers to implement a pragmatic plan for standardization
  • Facilitated the planning, architecture, development, and implementation of the standardization project

Labeling and Packaging                  

  • Managed multiple engagements to define and implement a label generation process with clear “end-to-end” accountability and integrated change control across all stakeholders for the Consumer Healthcare Division (OTC).
  • Designed a global product labeling process with focus on core and affiliate labeling decisions, single document repository (for text, artwork, and specifications), electronic workflow, and batching of changes to minimize the impact to affiliates, local health authorities, and manufacturing plants.
  • Implemented a formal labeling governance model to drive regulatory and medical decisions.
  • Managed the review of all documentation that supports labeling in the U.S. to ensure consistency and accuracy (e.g., Master Batch Record, Formulation, Regulatory and Medical Claims, Regulatory Text, CFRs and Monographs, and Packaging Artwork)
  • Defined and managed the system selection for an enterprise-wide labeling management system to control the end-to-end labeling and packaging process.