PV Process Design & Optimization, SOP Assessment & Creation

Process Design and SOPsForesight’s business transition methodology positions a company to be a best-in-class drug safety organization. We have a proven methodology to analyze, 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. 

Foresight uniquely has employees in the US, Europe, India and Japan with an average of 15 years of experience within industry before being hired by Foresight that lead and deliver the work — in either English or Japanese. 

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

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

The scope of services required differs for each of the above business scenarios and also on the resources available within your organization to update SOPs, deliver training and managed the rollout to affiliates, distributors and license partners worldwide.  Foresight is prepared to provide the full range of services required worldwide in English and Japanese.

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.  Foresight 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.  Foresight has performed many Global-Japan mergers and have proven solutions that have been in production for years at top 20 pharmaceutical companies.

SOPs must be assessed to determine the impact due to process changes and then must be updated.  Foresight performs the assessment and then assists in creating or modifying all SOPs for Global and Japan.  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.  Foresight manages the entire process for rolling out the new system and process worldwide to all affiliates.

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.  Foresight 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
Foresight can assist with defining the PV processes and creating the SOPs required to setup a new drug safety operation.  We have a preexisting 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.