Developing a Balanced Scorecard for a Core Laboratory
The balanced scorecard was first developed as a way for companies and organizations to more accurately measure their own performances. Today, these scorecards have evolved into vital tools for biopharmaceutical organizations to plan, measure, and manage their business strategies.
A balanced scorecard allows you to map out your own company’s vision and to monitor a vendor’s performance on the basis of that vision. Doing so informs your vendor about your own strategic objectives and invites it to support you in achieving them.
In a core laboratory environment, balanced scorecards can allow study sponsors to develop detailed snapshots of the lab’s performance. By evaluating relevant parameters, such as project management and data collection, sponsors can better analyze how different labs perform before choosing a core laboratory to manage their data.
Developing the Right Criteria
Outsourcing data collection and management to a core laboratory is necessary, but sometimes the process can be challenging. If you are not familiar with practices around centralizing clinical data collection, then you may have difficulty deciding whether a core lab vendor can and will adequately meet your needs. A balanced scorecard will help you identify the criteria that are most relevant to your company and then evaluate core laboratories by those standards. An invaluable tool for this stage can be found in the Metrics Champion Consortium tool sets, which also map standard process flows in each area.
Core laboratories frequently use balanced scorecards as means to measure their own performance metrics and as management tools to plan, communicate, and implement new strategies. Typically, a balanced scorecard will include four major perspectives: financial measures, customer satisfaction, internal business practices, and learning and growth. However, the specifics of the scorecard you use should be tailored and fine-tuned on the basis of the unique requirements of your clinical program.
When evaluating a core laboratory, you must first identify your data-collection needs and study end points. For instance, if you require several different types of data for your study, including cardiac safety and oncology imaging, then you may wish to choose a laboratory that collects data in a number of different areas in order to consolidate vendors. For pathology studies, you might benefit more from choosing a lab that specifically focuses on digital pathology, is experienced with current regulations, and collaborates with leading academic and medical experts to optimize the quality of those data.
How will a core laboratory train investigative sites to harmonize its data-collection methods? What has the company learned from studies similar to your own? Can it provide scientific or operational advice?
Internally, your balanced scorecard should include items that permit you to measure a core laboratory’s business practices as well as its expertise. For example, how does one lab’s turnaround time for data processing compare to others’? Does it disclose study risks and proactively manage issues? How would you know if the study had a problem?
Your scorecard should help you safeguard the quality of the data that the core laboratory will ultimately provide. Include items that let you measure how well the lab cleans the data, how responsive its employees are to queries, and how well it meets contract requirements (particularly turnaround time). Finally, do you need to know about outlier clinical data or about sites or site personnel producing outlier data? How frequently will you want to review that?
Regardless of which criteria you use, a balanced scorecard creates clarity between pharmaceutical companies and the vendors they use during important clinical trials. It helps to inform the vendor about your study and the team's key values and performance criteria, which balances interactions and lays the groundwork for creating mutual trust.
Crafting Better Relationships
Once the study is underway, reviews of the balanced scorecard will help maintain the working relationship between the core laboratory and the clinical study’s sponsors.
The cultural differences between sponsors and lab technicians, the sheer importance of the study, and any hiccups in the process can easily cause tension in teams. Using a balanced scorecard will inspire confidence in both parties by explicitly establishing the criteria by which the lab is evaluated, communicating the study sponsor’s priorities.
From choosing a core laboratory to maintaining the integrity of the relationship between the lab and study sponsors, the balanced-scorecard approach is the key to significantly improving the clinical study process.