Benchmarks are measurements that an individual or organization can use to assess performance. They can be determined within an organization (internal benchmarks) or as an average or range for a group of organizations (external benchmarks) in order to allow comparisons between different points in time. Benchmarks are an attempt to promote “organizational learning” by determining the time it took to accomplish a task or the parameters that were present to complete a project successfully. Organizations establish benchmarks as a roadmap of what development teams should attempt to do and not to do in order to increase success and minimize risk. The activities measured range along a spectrum from those that are well established and used to guide an organization to informal ones chosen as standards by a few people for the same purpose. Benchmarks may be created from data obtained from several or many companies, and some people view them as industry-wide standards. However, although some benchmarks are standards, many are not. Internal company benchmarks may be used as measures of progress or possibly of success in an activity within the company. These benchmarks usually illustrate results of a specific activity measured over a period of time, often one to five years.

The items benchmarked may be large and broad activities, such as the time required for synthetic work to create a chemical lead or project compound, time required for all advanced screening activities on a chemical lead compound, or time to first marketing submission from the first Investigational New Drug Application, or smaller issues, such as the time for protocol preparation, protocol review and approval, Institutional Review Board approval from time of submission, or completion of statistical analyses from the time of database lock. Many other benchmarks are listed later in this chapter.

Benchmarks may be based on data collected over any length of time, up to decades, and may be presented in many ways, such as numbers of specific activities expressed on a per
professional basis, as annual numbers, or as annual numbers calculated on a rolling average. Benchmarks may also represent subjective opinions of a few or many people, rather than being derived from objective quantitative data (i.e., the benchmark can be based on what “experts” believe a company or group should accomplish rather than being based on the average of what a group of companies actually accomplishes). While not widely used, subjective benchmarks could be the basis of how a company determines its own goals. The groups or companies contributing objective data to create an industry benchmark may be independent organizations, or they may all be part of the same parent company.

There are a large number of potential parameters to measure if one’s goal is to enumerate activities and behaviors that can be benchmarked. A few examples of benchmarks are given in the following sections as illustrations. Almost all of these can be viewed on an internal basis to evaluate an individual’s and a company’s performance from year to year and to judge if it has achieved the goals set the preceding year or the goals based on comparisons with other companies. If the latter comparison is desired, the underlying assumption is that the average of the companies contributing data to the group that collects them is accurate and the data are meaningful to use as a comparison (i.e., one is comparing similar or identical categories of data). It must be stressed that the author does not endorse many of these measures as relevant benchmarks to assess, but they have been used by various companies and are, therefore, listed. A company can create a goal for most of these or other benchmarks and track their progress on a periodic (usually annual) basis and then initiate or modify activities to assist the company’s efforts to achieve these goals. Alternatively, it can merely attempt to surpass the median or mean industry value for a selection of benchmarks if it has data that it believes are valid.

Achieving or surpassing accepted benchmarks could be a reasonable goal for a company that knows that it is not performing at the established benchmark level. For example, a company’s goal may be to have all data entered into a database three weeks after a clinical trial is completed, but the company’s current level of performance is that it achieves this activity in seven weeks, and the industry average (i.e., benchmark) may be five weeks.