Case Study: Pre-Clinical Testing Laboratory

Case Studies

Pre-Clinical Testing Laboratory

Project	This project was directed at improving overall operations of a multi—national, Fortune 500, preclinical drug testing company. This client provides a wide variety of services to the pharmaceutical industry by conducting preclinical trials of developmental drugs as well as “first dose in man’. This client also provides biopharmaceutical testing, cell growth and banking as well as vaccine production for the pharmaceutical industry. This project encompassed six major laboratories in the USA, one in Canada and one in the UK.
Objectives	The objectives for this project were to : Improve operational effectiveness and efficiency at each site. Improve the throughput and on-time delivery at each site. Provide better integration among the individual laboratories. Provide needed standardization of methods and processes among the laboratories. Provide recommendations for future strategic system development directed at lower operational costs through improved technology. Improve the revenues and profit for the entire corporation.
Unique Issues	This company was unique in that it had achieved its growth through acquisition and integration. This has historically been difficult in this industry. As a result, there was little interaction between individual laboratories and no standardized or shared processes among the facilities. These facilities were so loosely coupled that we found them to be unknowingly (and sometimes knowingly) competing with each other in the market place. This frustrated customers who were doing business with more than one unit of the company. Customer satisfaction was low with some major customers. Although all labs possessed detailed Standard Operating Procedures governing detail testing methods, they did not posses any process documents connecting these together in a contiguous set of processes for running the business.
Results	Improvements were widespread due to the size and complexity of the operation but are summarized as: Bottom Line Results. Over the course of our 2 year engagement with this client, the company’s overall preclinical sales rose by 41% and operating income rose 51%. Management Culture Changed. Insight 1, Inc. led this group from an informal management style to a process based style of management. This focused the management team on achieving performance through process management as opposed to relying on people to achieve on an ad hoc basis. Process Definitions as Operational Baseline Working at each of the 8 laboratories over time, Insight 1, Inc. facilitated the senior management team at each facility in defining a hierarchical set of process diagrams covering the entire operation. The lower levels of these processes were the basis for identifying and documenting these as Process Documents. Standardization of Processes Achieved As facilitators at each of the 8 laboratory sites, we were able to guide a high degree of standardization among the facilities’ operating methods. This was accomplished by assuring that the top level processes at each site were common across the preclinical organization. Additionally, we were successful in achieving approximately 75% commonality and standardization in lower level processes and Procedures. We established a standard process documentation numbering system producing common baseline document numbers throughout the laboratory systems. This facilitated the ability of personnel to move from one facility to the next and easily become familiar with the process management system and associated procedures. Modified Management Culture Using the Process Diagrams as the basis, we established an organization of Process Owners at each site. These Process managers/Owners had complete authority and responsibilities for assuring that these procedures were followed and that their processes were maintained accurate and in sync with the practice and were improved over time. This focused the management attention of the processes as the basis for performance rather than on people. Implemented a Performance Monitoring System Insight 1, Inc. led each site in developing a common set of performance measures and scorecards that were based on major process performance. These were directly tied to a set of performance measures at the corporate level permitting the corporate staff to track overall corporate performance as well as monitor any individual site’s performance. Developed a Global (Integrated) Marketing and Sales Operation Insight 1, Inc. led the organization in establishing and implementing a global marketing and Sales team. This team was facilitated to develop a global set of sales and marketing processes and procedures. These were subsequently implemented and over 100 sales personnel were trained. This succeeded in completely integrating the individual site sales operations into a truly shared resource for the corporation. We assigned centralized account management responsibility to the facility with the most revenue for a single customer. In this manner, the internal competition was eliminated. A Vice President of Marketing and Sales was established for managing the global sales capability. Developed First Preclinical Marketing and Sales Plan We then led the team in developing a Sales and Marketing Plan during which the first preclinical SWOT Analysis was performed as part of a comprehensive market analysis. Through this activity, the sales team recognized that, as an integrated organization, they possessed much more capability than any single group realized. This led to expanded sales opportunities. Expanded Integration Through Improved Networking and Shared Data We discovered that the individual facilities did not even possess dependable email capability for interoffice communication. This was vital for the sales and marketing team. An improved network was implemented providing new email and communication capabilities. We implemented Insight 1, Inc’s OneWindow® for managing the team’s global processes and procedures as well as important performance and status data. This greatly facilitated the institutionalization of the global integrated sales organization. Individual Facility Operational Improvements Defined and Implemented We found common threads of areas needing significant improvements as we moved from site to site. The most significant are summarized as: Established an automated test room and resource database that permitted forecast of resource utilization that was used to schedule and manage the resource utilization. This resulted in increases in apparent capacity, better on time start of test projects (assuring timely delivery of results) and elimination of wasted time with non utilization of resources. Reengineered the reporting processes and standardized it across the facilities. The primary product of these test projects are technical reports. These must be delivered on time to meet customer requirements and to keep the process of drug development flowing. These processes were simplified cutting costly time out of the writing, review and submittal schedules without compromising quality. Test Projects are conducted in accordance with a test protocol which is developed and approved by the client prior to start of testing (by regulation). Each facility had a variation of the approach to developing these critical project documents. No standard templates were available. We led the teams in identifying standard categories of testing projects and in developing standard protocol templates for reach. We improved and standardized the development process. This not only produced consistency but also reduced the time necessary to gain protocol approval by the customer assuring that planned test start dates were not compromised. This was a significant improvement in customer satisfaction as well as gains in revenue. Improved the handling and accountability for controlled substances and brought several facilities into solid compliance with regulatory requirements. Established a Corporate Technology Architecture and Strategic Development Plan We recognized that the corporation lacked integration of new technology leading to additional large operational improvements for the future. Insight 1, Inc. also recognized that the company required three significant core competencies: Animal Husbandry, Test Management, and Large scale Data Management. We drafted an integrated system architecture reflecting new core systems for each of these core capabilities. We recommended a state of the art animal census and husbandry system. This did not exist in the company and this requirement for managing thousands of animals at each facility was virtually a manual, paper based operation. This was so significant that the company selected a common automated system for implementation across the corporate structure. We also recommended the use of RFID chips for animal identification and tracking. This alone would enable automation and integration of the husbandry, test execution and data collection and management functions. This was true because of the common linkage between the animals and these vital functions. The test staff could move from one function to the other by simply scanning the animal’s implanted chip. Expanded the Company’s Primary Services and Products We found one facility to be unique to the rest in that it was involved and expert in biopharmaceutical testing services as well as in cell and vaccine manufacturing. While a small operation, the company was not sure what to do with this facility. With the leadership of a new general manager and our assistance this business was expanded and improved significantly. Resulting in significant increases in revenues and profits. It became so successful that the company expanded this strategic capability by acquiring facilities in Ireland and Germany.
Description of Services	As part of our overall project to improve operations for this client, Insight 1, Inc. performed the following tasks in support of the operational improvement: • Developed a set of process diagrams for the each major facility/lab within the corporation. This included 8 major hierarchical process diagrams and a common Infrastructure and support Process Diagram. New operating Procedures were developed and implemented in each facility or functional service area. • An assessment of all operations was conducted and improvement initiatives were identified and then prioritized based on the impact to overall operational performance as well as with respect to key organizational goals. • Process Improvement Plans and Approaches were developed and these executed to obtain widespread improvements.
Methodologies	Utilized Insight 1, Inc.’s unique methodologies for facilitation and documentation of hierarchical business processes as well as application of lean practices to eliminate waste, improve product flow and reduce errors.