"How has PHARMICA helped other R&D teams achive operational excellence?"

reporting capability for R&D.This consisted of a vendor analysis on reporting tools and defining how reports for the portfolio, project, and study would be used within the business processes. PHARMICA Consulting integrated data from CTMS, IVRS, Oracle Clinical, Microsoft Project Server, and other custom databases into a consolidated set of automated reports in Microsoft SharePoint.

Benefit
The client now has one place in Microsoft SharePoint to obtain the latest reports, dashboards, and KPIs for R&D. This allows team members, department heads, and executives to receive timely updates no matter where they are globally. In addition, team members have a common process for managing projects and studies with standard reports and data regarding their progress towards timelines. This allows team members to react more quickly to project issues and to implement the necessary corrections to meet timelines. Because of the experience of PHARMICA consultants with CTMS implementation and reporting capabilities, the client received a process with clear roles, responsibilities, and triggers which provided quality updated data in reports. Executives and team members utilizing the reports now have confidence in the data quality in the reports.

Process Optimization (Case Study #3)

Issue
A pharmaceutical company was growing quickly and wanted to instill a culture of process improvement within R&D as it grew. The company was unsure how to best approach this objective, how to best implement it, and how to ensure process improvement would be embedded in their culture.

Solution
PHARMICA Consulting leveraged its two-phased approach for process improvement. First, we conducted interviews and facilitated group sessions to determine the issues, areas for improvement, the value of each project, and developed a roadmap to implement the projects. Part of the ultimate solution consisted of building a project management group to own and implement the roadmap. During the second phase of the project, PHARMICA consultants worked with the client to select the best projects to implement. The projects consisted of developing and implementing a portfolio management process, a project process, and a study process. Within each process, we identified key areas critical to increasing productivity.

Benefit
The client received both a standard process and tools that allow them to follow through on the strategy for bringing a drug to market. Teams received standard tools for developing timelines and costs for each project. A portfolio management process was defined for project teams to present the strategy, timelines, and costs to the executive committee to receive approval for their plans. Executives received a standard presentation format and evaluation criteria to help them better determine which projects to fund and which projects to terminate. A project management group was formed to develop and maintain a roadmap for continuous improvement and to review and evaluate new initiatives that could be added to the portfolio. Moreover, the organization now has a solid process in place to periodically identify, evaluate, prioritize, and implement future improvement projects.

Portfolio Planning & Resource Management (Case Study #4)

Issue
A large pharmaceutical company could not accurately project timelines and resources, either for a study or for the portfolio. In addition, there was no standard process across teams for managing projects. Because of this, the company could not proactively identify project risks, resource gaps, and impacts of changing timelines on bringing a drug to market.

Solution
PHARMICA consultants helped this client develop and implement an enterprise-wide planning and resource management capability. A rigorous project management process surrounding the software development lifecycle process enabled the project team to deliver on time and on budget. Key PMO tools used during the software development lifecycle were project planning, risk and issue management, quality management, communication plans, and change management plans. Key Six Sigma tools utilized were process mapping and measurement, root cause analysis, data gathering plans, Pareto diagrams, development of resource management algorithms, facilitation techniques, and benchmarking, among others.

Benefit
The solution enabled the development of a PMO with standard project management plans that enabled the client to understand the impact of changing time lines on resource estimates. In addition, it allowed the client to conduct bottoms-up planning for the annual R&D budget, and to implement a project management process for bringing a drug to market.

R&D Collaboration (Case Study #5)

Issue
A pharmaceutical company had multiple locations for all project and study documents to reside. As a result, version control problems for key documents were constantly leading to confusion and rework. In addition, study team members either did not use reports and metrics or used different reports and metrics for different studies.

Solution
PHARMICA Consulting implemented SharePoint team sites to store and control master copies of key project and study documents. In addition, our consultants integrated data from CTMS, Oracle Clinical, Microsoft Project Server, and other databases, to create a common set of reports and metrics that resided in a centralized R&D Metrics SharePoint site.

Benefit
The client received a tool for creating and storing documents, and a detailed process to go along with it. As a result, team members now have a central repository for all key documents, and version control issues have been eliminated. Team members and executives also have one place to go to access the latest metrics and reports. Now, all R&D employees utilize the same reports for all projects and a common process for managing projects and studies, improving efficiency and productivity across the organization.

Small Company Growth (Case Study #6)

Issue
A small pharmaceutical company was consistently missing timelines for projects and studies. The client was growing quickly and they did not have a project management department, processes, or tools to successfully handle the growth.

Solution
PHARMICA consultants conducted surveys to determine specifically what needed to be built and implemented, rather than approaching the client with a “canned” approach. The consultants:

• Developed standard portfolio, project and study management processes
• Developed tools to develop the strategy for bringing a drug to market
• Developed a standard, detailed timeline for brining a drug to market
• Defined standard team roles and defined the responsibilities of each role
• Developed templates for determining the costs of projects and studies
• Implemented R&D systems, such as CTMS, Mircorsoft Project Server, and Microsoft SharePoint
• Developed and implemented a metrics R&D program.

Trained executives and team members on how to use the processes and tools Developed the organizational structure of the project management department, defined roles and responsibilities, and utilized the recruiting arm of PHARMICA Consulting to find a head of global project management, project managers, schedulers, and analysts.

Benefit
The client received a standard process and tools for teams to articulate the strategy for bringing a drug to market. Teams received standard tools for developing timelines and costs for a project. A portfolio management process was defined for project teams to present the strategy, timelines, and costs to the executive committee to receive approval for their plans. Executives received a standard presentation to determine which projects to fund and which projects to terminate. A project management department was staffed with the correct skill set based on the consultant’s deep knowledge of the clients’ needs and the complexity of the project and portfolio management capability. R&D systems were implemented to serve as a platform for managing and measuring studies and projects. Metrics became the norm rather than the exception. Most importantly, the executives for the first time had a scalable process for effectively managing the portfolio.

Defining and Measuring Clinical Research Productivity (Case Study #7)

Issue
A client wanted to get a better sense of its clinical research productivity and use this knowledge to optimize resource allocation in order to conduct more studies within the same budget.

Solution
A PHARMICA consultant worked with the client as a member of the core team in an effort to first define productivity as it applied to the client’s situation and then to determine the appropriate metrics that needed to be captured. Subsequently, data sources were decided upon for feeding into a database, which was used for both reporting and modeling purposes.

Benefit
The client was able to assign a localized per visit cost for conducting trials in each of its fifty subsidiaries around the world. Furthermore, when combined with information on other dimensions such as speed, these costs helped the client to truly understand each subsidiary’s contribution to overall productivity and to then select the most appropriate subsidiaries for a trial based on the trial’s specific needs.

Building Effective Teams (Case Study #8)

Issue
A pharmaceutical company did not have team roles, responsibilities, and goals clearly defined. As a result, team members did not trust each other, team members were not being held accountable, and ultimately, team goals were not being achieved.

Solution
PHARMICA consultants utilized the PHARMICA Five Step Methodology For Building Effective Teams. First, the consultants assessed the situation by attending team meetings and just observing the current team dynamics. Second, the consultants interviewed team members one-on-one and in small groups to further understand the issues. Third, working closely with the client, the consultants developed a gap analysis and road map to create standard roles, responsibilities, and use of tools and processes for all teams. Fourth, the consultants implemented the solution by working with each team to practically utilize the standards, processes, and tools developed in step three. Fifth, the consultants conducted another round of interviews with the teams and individuals to further improve the definition of team members, their responsibilities, and how the tools should be used to further clarify and, most importantly, achieve the team goals.

Benefit
The client was able to drastically decrease the amount of unproductive time spent discussing and often arguing about:

• Who should be doing what?
• What is the plan?
• What are the goals of the team?

Team morale increased because a plan was collaboratively developed, documented, and managed in a consistent process. This clarity led to trust and teams achieving near-term goals. Team members were able to create more sophisticated plans to decrease cycle times for bringing a drug to market because the fundamental plan was clarified and documented.

Mergers, Acquisitions, and partnerships (Case Study #9)

Issue
A major pharmaceutical company was in the opening stages of the acquisition of a biotech company. It needed to assimilate all of the target company’s intellectual property and key data in a relatively narrow time frame. This involved determining what data existed and where it was located, what systems were being utilized, what other assets needed to be evaluated and shipped, and how all unwanted systems, equipment, and documents would be disposed of. The company needed help in determining the best way to accomplish these tasks, as well as help in managing the myriad workstreams involved.

Solution
PHARMICA Consulting worked with the client to evaluate the situation and prioritize objectives. Using its proven project management methodologies and tools, PHARMICA consultants created a detailed project plan and proceeded to manage each of the diverse workstreams. PHARMICA also provided critical content knowledge in the areas of integration strategy, clinical systems, and vendor management.

Benefit
The client was able to successfully execute on the plan and complete the integration within its aggressive timelines. All assets were acquired by the client or properly disposed of, and the intellectual property was captured and catalogued in such a way as to maximize the value of the acquisition while minimizing confusion. Furthermore, because the client was left with a set of tools, processes, and decision logs, it is now in the position to be move quickly on the next integration emergency.

Contact us to learn more about how PHARMICA Consulting can help you address these and other operational excellence challenges.