Business Transformation

Business Transformation (BT) integrates key aspects of your project to deliver successful change.  Within Foresight, these key elements are delivered through the leadership of our business transformation team. Business Transformation

  • Business Transition: process harmonization and optimization activities, SOP impact analysis and creation / updates
  • Business Change Management: change vision and leadership alignment, impact assessment and change readiness, communication and stakeholder engagement
  • Training: training approach and curriculum, training materials creation and delivery

Each of our employees within the BT practice come from industry with an average of 15 years of industry experience within clinical, regulatory or drug safety departments prior to joining Foresight.  With BT employees in the United States, Europe, India and Japan we provide local knowledge world-wide in both English and Japanese.

Foresight has proven methodologies and approaches to business transformation from over ten years of delivering many projects to companies of all sizes and types. Foresight takes a hands-on, active role in guiding clients through simple and complex process and system changes alike.  We plan an implementation strategy taking into account the unique circumstances of each client.  Foresight’s unique ability to provide proven business resources to lead and delivery our projects enables our clients to focus on running their existing operations while participating in the business transformation project part-time. We guide our clients at every step of the way, “rolling up our sleeves and supporting our clients however necessary.

Typical Business Transformation Engagements

PV Operations Consolidation

Following a corporate acquisition or merger, companies are faced with the challenge of combining safety systems, processes  and operations from multiple business units / companies into a single organization, process and system as well as ensuring that interfaces with regulatory affairs, medical affairs and clinical operations are defined and effective.  Sometimes this is done immediately after the M&A and often times years later after running multiple standalone systems with separate processes and complex technical and functional handoffs across businesses or regions (e.g., Global and Japan running standalone systems).

Foresight has a proven methodology for harmonizing and consolidating PV operations.  Our business transformation resources redefine the new organization, work with each entity to harmonize and optimize business processes, coordinate with the technology team on safety database workflow design, assess the impact the new process and system has on SOPs and then assist with creation of the new SOPs, develop and deliver training materials worldwide and manage the deployment across affiliates, license partners and distributors.

Global – Japan Process Harmonization & PV Operations Mergers

Foresight specializes in merging the PV operations of global and Japan business units for companies of all sizes and types.  We have full-time business transformation employees that are bi-lingual in Japan that work with our global BT resources using proven methodologies for harmonizing the processes used globally with those of the Japanese PV operation.  We have performed 10+ projects with both Japanese headquartered and global (US or EU) headquartered companies to harmonize their processes successfully.

Training Design, Development & Delivery

Foresight has a very mature worldwide training practice for Argus Safety, Argus Safety Japan, and all of Foresight’s products (e.g., PVM, PVQ, PVI, etc.).  We have standard training materials in both English and Japanese and a training certification program for our trainers.  The training practice is managed within our business transformation practice and all business resources are staffed from our BT practice.  However, we also have certified trainers from other practices within Foresight that are SMEs on Argus or the Foresight products that help deliver IT administration training and the end user training.  Training can be delivered on-site or off-site.  Finally, many of our employees are also fluent in Chinese, French and German, so we are able to deliver training in other languages if required.  For example, often times Japanese PV operations are outsourced to China based CROs, so the Japanese case processing training is delivered in China where it is helpful to have our tri-lingual (English, Japanese and Chinese) trainers.

Process Design & Optimization, SOP Assessment & Creation

Foresight has proven methodology to optimize safety, regulatory and risk management business processes.  Our employees are skilled in using LEAN process techniques combined with a deep knowledge of industry best practices to rapidly assess your current processes, define optimized ‘to be’ processes and then most importantly implement the new processes.  Our team first leverages existing materials to determine the ‘as is’ processes, determine where there are non-value added tasks, rework loops and manual steps that could be automated, reduced or eliminated entirely.  We then conduct workshops with key stakeholders from all regions (including Japan) and work with IT resources from both Foresight and the client to define the optimized business process that maximizes the capabilities of your staff and the systems you have invested in. 

Foresight uniquely has the capability and scale to also help you implement the changes required to optimize your process.  We have BT and IT resources in each of the regions where companies have major case processing centers. We have the functional, technical, language and regulatory knowledge to assist with delivering the solution: manage the overall program, create SOPs in English or Japanese, create and deliver training in English or Japanese, and provide business resources on-site in each central case processing location worldwide to support the rollout of new processes and/or systems.

Signal Detection, Evaluation and Management

It is essential to implement proactive risk management and signal management strategies, processes and systems to ensure the safety and efficacy of your products and to meet and track regulatory obligations.  We work with our clients to ensure the proper technology solution is selected to meet the needs of your business.  Often times companies buy a new signaling tool and then determine how best to use it.  At Foresight, we first perform a risk based assessment of  your portfolio of products to determine which tools you require — if any, and then we help you evaluate and implement a new process and system.  We also have proprietary tools for signal management and risk commitment tracking which save effort and increase compliance.