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| At Pharmica Consulting, we are committed to giving clients practical solutions to complex business problems. Here are some examples of the projects that we have worked on with major pharmaceutical clients. | ||
| "We partnered successfully with the founders of Pharmica Consulting on several projects over a 10-year period. They knew the details of the pharma R&D business before they arrived. There was no need to spend valuable time explaining the process. Among the projects to which they contributed, they were instrumental in helping us establish clinical research performance metrics and an on-going system for gathering and analyzing performance data. Also, they were critical in designing and delivering worldwide implementation and training of numerous new clinical data management and trial management software applications. They were consistently conscientious, reliable, and a pleasure to work with. They place a premium on integrity, relationships, and results. I do value their expertise and work ethic and have a high regard for their consulting services." |
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| -Dr. Jacobo Sabbaj, Retired VP, Merck Worldwide Clinical Research Operations | ||
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| Case Study 1: Portfolio Planning and Resource Management |
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| 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 timelines 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. | ||
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| Case Study 2: Performance Monitoring Through a Sustainable Metrics Environment |
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| Issue | ||
| A clinical research operations group within a large pharmaceutical company needed to find a way to measure and improve performance. There were no consistent standards on how to measure performance, and no standard reports to provide guidance for performance management and benchmarking. | ||
| Solution | ||
| A Pharmica consultant designed and implemented a global clinical metrics program that enabled the client to proactively identify process issues and use data to make business decisions. To justify the project, Pharmica consultants developed a business case with a detailed implementation plan. The plan was executed utilizing a variety of data gathering techniques, benchmarking, and prioritization matrices. In addition, the consultant provided the guidance and support for developing a central process monitoring group. | ||
| Benefit | ||
| The client was able to manage study progress by analyzing a key set of metrics that was agreed to and understood by all study team members. The client had access to meaningful, real-time data that decreased fire fighting due to more proactive identification of study issues. In addition the client agreed to one set of numbers that all study members used to understand study status. A baseline database was created in order to gauge past performance and was analyzed and used for many subsequent improvement initiatives. | ||
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| Case Study 3: Defining and Measuring Clinical Research Productivity |
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| 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 clients 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 trials specific needs. |
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| Case Study 4: Process Measurement and Management Development of Tools to Measure and Manage Clinical Data Processes |
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| Issue | ||
A large pharmaceutical company was implementing a new continuous data flow (CDF) process. Because this was a new process, the appropriate metrics did not exist, nor did any tools that could be used by the client to manage the process and therefore meet the target cycle-times for data management. |
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| Solution | ||
| A Pharmica consultant created metrics based on the new process milestones and process flow. Having an in-depth understanding of what the client was trying to accomplish, the consultant developed new process management tools in the form of a detailed automated Excel report, scatter plots, and control charts. These were developed with input from end users so as to maximize the tools' value. | ||
| Benefit | ||
| The client was able to manage the new process with ease. The Excel tool was used by the "on the ground" employees to get detailed reporting on individual sites and the status of patient data for any visit. The scatter plots were used in a proactive manner in order to identify sites that were having problems before they fell too far behind. Control charts were used to call out any special problems almost immediately after they occurred. Lastly, the information pulled from these reports was used to rapidly identify where best practices could be found. | ||
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Case Study 5: |
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| Issue | ||
A large pharmaceutical company was starting up an oncology department and did not have a first class project management methodology for project planning. Because of this, project managers and core team members utilized methods of varying quality for planning and managing their projects. |
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| Solution | ||
| A Pharmica consultant developed a planning process, and a metrics, and benchmarking program specific to oncology studies. This included planning templates for timelines, resources, metrics and regulatory guidelines. In developing this solution, Pharmica consultants utilized project plans, communication plans, risk plans, interview techniques, process mapping, developed KPIs, affinity diagrams, root cause analysis and other PMO, PMI and Six Sigma tools and techniques. | ||
| Benefit | ||
| The oncology department was able to better plan for projects based on a standard process. For each project, the client was able to evaluate timelines, regulatory strategies, metrics, cycle times, and costs, as well as make changes to align with industry best practices. | ||
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| Case Study 6: Site Initiation and Management |
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| Issue | ||
| A client wanted to reduce study start up costs and improve the training of investigators and study coordinators on protocol-specific requirements. Client staff had experimented with using web cast meetings to replace expensive live investigator meetings. However, they were frustrated with the logistical problems of scheduling multiple international web casts, time-consuming log-on procedures, and the poor quality of the training. Furthermore, clinical teams were looking for a way to "certify" investigators and study coordinators in GCPs and study-specific procedures, and to keep a database of who had been certified. | ||
| Solution | ||
| Pharmica consultants helped the client develop a business case to assess the circumstances under which FIRECREST Clinical would yield the greatest financial benefit. The client decided to use FIRECREST to replace an investigator meeting for a large Phase IV clinical study. | ||
| Benefit | ||
Their cost reduction objective was met by saving approximately $900,000 in study start-up costs for one protocol. Furthermore, investigators, study coordinators, and CRAs praised the FIRECREST Clinical training program for its state of the art instructional design, its just-in-time availability, and its availability in staff turnover situations. On the basis of this experience, the client decided to completely abandon live investigator meetings in the future. |
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