Introduction
The relationship between Sponsor Companies and Contract Research Organizations (CROs) is changing. Over the past three years it is estimated that outsourcing by pharmaceutical and biotech companies to CROs has increased more than 15–20% per year. Current merger activity within the pharmaceutical industry continues at a record pace, which is increasing the number of new products in the research pipeline. This is increasing the demand for contract research services. CROs face a challenge in tracking and prioritizing multiple concurrent projects as a result of increased demand for the contract services provided. The successful CROs must capitalize on economies of scale and must deliver their contract services with an emphasis on speed and quality.
Exhibit 1. Web-Based Integrated Project Tracking System
The three key areas that allow for metric prioritization are deliverables, key numeric metrics, and the process methodology. The deliverables are selected from the master critical success factors list of the Project Management System (PM Sys). The metrics are based on the quantifiable variables from the industry such as patient enrollments, CRFs completed and financial performance. The web system and methodology is required to collect the results and display them in highly visible format, run reports and complete the analysis.
Exhibit 2. Plan vs. Actual Criteria (Partial Listing)
This system is currently implemented at several CROs and actual results will be discussed.
The Web/Internet
The Internet provides the perfect medium for allowing CROs to track projects. CROs tend to be distributed organizations with program managers and team members all over the globe. Most pharmaceutical companies are currently conducting trials in a global manner and the global capability is a significant advantage to CRO organizations.
Other conditions that make an Internet solution ideal include:
• Project managers work from remote locations, which may be in home offices and other countries
• Data must be shared with management, clients and interested parties in real time, which could be hourly, daily, and monthly
• There are a large number of projects to track in an organization
• High phone costs for connecting long distance to a host via RAS
• Accuracy of information is crucial for the success of a drug trial
• The timeliness of correcting a problem situation is significant
• Project costs are in millions of dollars involving many persons and organizations
• The business risk is high if drug product is not approved because of errors.
Exhibit 1 is a schematic of the web-based integrated project tracking system. It has the capability to track an almost unlimited number of projects. However, the largest CROs typically reach capacity managing between 50–150 projects.
A set of metrics is developed around the organizational objectives to provide real-time monitoring of projects as Red, Yellow, or Green. Red, being projects that are moving toward failure; Yellow, projects that are high risk; and Green, projects on schedule, within budget and meeting client expectations. Special procedures are instituted for red projects so that the issues are well documented and get immediate attention by executive management. Since the projects are now prioritized it is easier to focus high-level management attention on a critical few projects rather than a wide range of projects. As Vilfredo Pareto asserted, that 20% of the projects would yield 80% of the problems. The identification and location of these 20% is the major benefit of the system.
Metrics
A metric is defined as “a standard of measurement.” Everything that is done in a project management system should have a metric and a way to determine if it is on track. In this system we focus on metrics as they are related to the measured variables.
These metrics are then applied to the project variables and the projects are then rated for review. The Reds get the highest priority review, Yellow next and then Green. The 80/20 rule states that 20% of the projects are causing 80% of the problems. Most project management systems have difficulty in identifying the 20%. This system locates, identifies, and prioritizes those projects. More rules and methods will be discussed later in this paper.
The Basic Project Management System (PMSys)
A CRO Project Management System (PM Sys) is unique. Clinical monitoring projects have varying time frames from two to three months to two to three years. The high risk of using experimental drugs on humans necessitates close monitoring. Enrollment of patients tends often to be the most often reported issue and must be closely monitored. Proactive contingency plans must be applied as required to maintain key schedules.
The PM Sys establishes project goals by selecting the pertinent activities to be accomplished. It also delineates key stages of project development, defines objectives, and assigns accountability for each stage. The PM Sys provides a standardized method of initiating, managing, reporting, and completing a clinical project.
The project manager determines the scope of the project based on a review of the project proposal, contract, and hand-over documents. The PM Sys is initiated by the entering of project specifications and deliverable selection/assignments into the PM Sys database. The project manager selects the deliverables appropriate for the contract and the following is assigned to each deliverable:
• Name of responsible party
• Date due
• Percent complete
• Date completed
• Status of the deliverable in Red, Yellow, or Green
• Comments.
The unselected deliverables must be assigned a non-selection rational, such as, “not required” or “service not contracted.” The project manager provides a deliverable selection report, and a non-selection deliverables report to senior management for review and approval. This is considered a critical part of the initiation of the PM Sys and includes a basic project overview, deliverable selection, project timeline, and cross-functional team deliverable assignments.
The PM Sys defines seven stages of the research development process:
• Proposal
• Development/Planning
• Site Initiation/Monitoring
• Data Management
• Analysis/Reporting
• Regulatory Applications
• Continuous Improvement.
The project manager tracks the progress of deliverables associated with each stage making resource, timeline, and task adjustments as required by project developments. A stage exit review meeting occurs at the completion of each stage and includes the project manager and group director. A Stage Exit Approval Form is completed which documents approval for proceeding to the next stage of development and/or provides an action plan.
Checkpoint Reviews occur three times during the life of a project:
• Upon completion of Stage number 2 Exit Review (end of planning)
• Upon completion of Stage number 4 Exit Review (end of data collection)
• Upon completion of Stage number 5 Exit Review (end of documentation preparation).
Checkpoint Reviews are mandatory and must be attended by the project manager and senior management. This review serves as formal appraisal by senior management of project status. A Checkpoint Review Form is completed by the project manager and reviewed by senior management. The approvers determine the status of the program in the event the Checkpoint is not approved and will direct the project manager in the appropriate actions.
There are several key features that guide the overall development of a system:
• Accountability
• Value—Add processes only
• Responsibilities clearly defined
• A uniform system across the corporation
• A fully documented system for client certification.
The most critical element of any system is the ability to evaluate people's performance. This is accomplished with an Accountability methodology. The challenge is keeping all project leaders on track and on schedule without micromanaging their work. This process is accomplished through a formal set of reviews that are scheduled at specific times in the stages of the Project Management Process. The stage reviews get scheduled at the end of every stage. The Checkpoint reviews are scheduled at key points in the process where major business commitments occur. In the CRO application checkpoints occur before Site Initiation, Analysis/Reporting, and termination of project.
When working with professionals and project managers, it is key to assure that all work is “value-added,” which is accomplished by providing a mechanism for selecting deliverables. This process assures the system integrity. However, there needs to be a balance between what the experts had determined as required deliverables and what the customer and business needs to assure success. This step is the role of senior project management since the needs of the client have to balance against the profitability of the organization.
Responsibilities need to be clearly defined for each of the persons on the implementation team. The methodology requires a specific person to be assigned.
A uniform system across the corporation is essential so that there is 100% consistency across project managers. For those corporations where project management is not all onsite, consistency is a concern. Many CROs have over half of their project management staff at remote locations. A uniform system provides a vehicle to assure that people are consistent with their work. In a worldwide implementation a common system can prove invaluable to facilitate communication among divisions. For those places where program management is local, a uniform system provides a way for people to share ideas and improve their work content.
The following key principles were applied to create the most effective system for the CRO.
• A Vision
• Segmentation
• Accountability
• Ease of Use
• Uniformity
• Controlled Rollout
• Facilitated Development
• The World Wide Web.
The vision necessary for the system to be viable comes from the top executive in the organization. In the early stages of any implementation of change there is always a significant level of resistance. The voice of executive management aids in keeping people focused to the benefits of a PM Sys.
Exhibit 3
Segmentation divides the complex task of managing a multiservice project into manageable pieces. Typically, the CRO industry drug data collection and analysis approval cycle is one to three years. It is crucial to identify key process events and identify closure on items. Each one of these stages represents a key logical activity to move the services and activities from initiation to project completion. A stage should not last more than two to three months so that progress can be monitored and the process remains highly visible.
As each segment progresses through the Project Management Process, four additional key components are required: Objectives, Inputs, Exit Criteria, and Accountability. The objectives clearly specify the things that are to occur during each respective stage. For example the Development stage objective would read as follows: “Initiate appropriate procedures, systems documentation, and resources to satisfy protocol and client specifications.” The inputs are those items that are required for stage initiation. Input elements for the Development stage include client specifications, resources, and internal assumptions. The exit criteria include those elements requiring completion/resolution to properly exit the stage. Development stage exit criteria include key deliverable completion (i.e., case report form (CRF), protocol, investigator identification, etc.), and project scope agreement.
Accountability is key to making the system work. Proper monitoring of the work content of team members at key points in the process will assure that the work is being performed properly. There are multiple layers of accountability in the PMSys system that include all team members and executives. Every deliverable is specifically assigned to an individual so that the person performing the work knows exactly what is expected. Each deliverable is assigned a status code of Green, Yellow, or Red. The status color defines the overall condition of the deliverable. A Green coding means everything is normal with only minor problems. A Yellow deliverable indicates there is a significant problem, however, the responsible person with an action plan to resolve can handle it. A Red deliverable indicates a serious problem that requires resources outside the project team for resolution. For example, a Red deliverable might describe a sponsor-related issue that must be resolved at a high level. An example of such an issue might be low patient enrollment in a clinical protocol. If sufficient patients are not enrolled to meet protocol requirements, then the overall project schedule will be delayed and critical milestone dates will be missed.
Quantitative management reviews are required to execute the accountability strategy. These reviews are organized through the use of stage exits and checkpoints. The stage exits occur at the end of each stage and consist of a structured review. The objectives and exit criteria for each stage must be satisfied in order for the project leader to have a satisfactory review. For example, an unresolved CRF design issue may greatly impact the integrity of clinical data collected and therefore may in turn force a delay in patient enrollment, data collection, review and entry. A delay at this stage is preferable to allowing issues to “ride” through stages since a failure to fix the problem at an earlier phase could very well require a more time consuming and expensive fix later in the process. “Stage riding” increases the cost of problem resolution by a factor of 10 for each stage skipped.
Ease of use is essential when trying to gain acceptance in a large organization. In general, there will be a wide distribution and use of the PM Sys throughout the organization. The PMSys provides an email interface so that notification can be sent to responsible individuals concerning due dates, status and percent complete. This automatic notification will assure organizational commitments are kept on schedule. The number of days to look forward is specified at the initial prompt and emails are automatically generated with all key information.
Uniformity of the system is developed from a central architecture, which clearly shows all aspects of the work performed at the organization. The uniformity concerns are: (1) Single Architecture, (2) Maximum set of deliverables, and (3) Comprehensive Task-lists and Forms for each deliverable. The single architecture allows the overall PM Sys to be easily distributed throughout the organization. The single architecture is constructed of the specific stages, specific deliverables, and well-defined review processes.
A Controlled Rollout is preferred as the PM Sys is introduced to the entire organization. The first phase should include a pilot study demonstrating project-level functionality. A simple, straightforward project should be selected with a seasoned project leader assigned to manage the pilot activities. The results of the successful pilot should be shared with the organization. Following this, each project leader should guide a single project through the PM Sys. This will allow for a successful, minimally stressful introduction to the system.
A Facilitated Rollout is key to the success of a PM Sys. A consultant or a dedicated team is needed to keep the focus on systems development.
The Project Tracker
The Project Tracker is a primary element in the metric prioritization system and the principle reporting mechanism for the PMSys. In some respects the Project Tracker is the real time eyes and ears of the PMSys. This system tracks the status of all programs on a monthly/weekly basis. As stated previously, CROs manage a range of between 20 to 200 projects simultaneously. The project tracker consists of carefully selected fields that are updated every month to show the overall status of a project.
1. General status information—This contains client name, drug indications, and start and end dates.
2. Status—A Green, Yellow, or Red rating is applied to the project based on the overall issues and judgment of the project manager.
3. Monthly Activity—This is information obtained from the project manager about sites, enrollment, CRFs and DCRs. The planned data is compared to the actual data and is tracked and highlighted if outside acceptable limits.
4. Personnel status—The performance of fee-based individuals is tracked such as CRA utilization. This information is entered automatically
5. Financial information —Revenue, expenses, and cash flow are tracked automatically and compared to expected variances.
This information is compiled and reviewed at monthly meetings held with all project leaders to create trigger points. These trigger points require the project manager to create action plans and to take control over the issue. To maximize the efficiency of the review, all projects and programs are prioritized based on color code. In addition to this monthly data, graphs are plotted from historical data to show critical relationships and trends. In the CRO business, it is very important to be able to predict the rate of completion for activities such as enrollment that compels an organization to be proactive. For example, if a given project has an enrollment period of five months and requires 100 patients, the average projected patient enrollment numbers 20 per month. If this rate decreases dramatically during a given time period, the project leader will infer missed target enrollment based on the tracker's linear regression modeling prior to completion of the actual enrollment period. This will allow for the implementation of contingency plans in advance of the enrollment cutoff period. The system highlights rate-limiting situations early so that corrections can be made and project plans realized. The following is an example of metric assignments for revenue attainment shown in Exhibit 3. By performing a linear regression on the existing data we can see where the rate of revenue attainment crosses the expected contract high. If the intersection is near to the planned end date the project is on track and rates a green. If the intersection were not coincident with the due date, then it would require a Yellow or Red status depending on the degree of it missing the target.
The key to project visibility is the Project Tracker. The Tracker is generated monthly and distributed to all functional group heads. The Tracker contains key metrics such as Active Sites, Patient Enrollment and CRF errors. Each stage of the Project is also color-coded which indicates the level of issues facing the team. Project Trackers for all active projects are consolidated into a single monthly Project Tracker. Monthly Project Review Meetings utilize the consolidated Tracker as a tool. The Tracker is prioritized with Projects designated “Red” listed first, “Yellow” projects second and “Green” projects are last.
For example: Only projects designated Red and Yellow are routinely reviewed at the meeting in less than an hour. Initially attempts were made to review all projects that took all day. Attendees of the meeting quickly realized that projects designated Green did not require any assistance or increased oversight therefore required no management review. The monthly meeting now focuses only on the projects with issues rather than all projects. This is an example of management by exception. The meetings move more quickly and attendee's focus on providing creative solutions to the issues identified. Sponsor acceptance of the process has been good. Clients over the past few months have requested that they receive a copy of the Tracker.
Benefits Achieved From the System for the CRO
This system was implemented in about six months and has proven to be a good return on investment for the CRO. There was a dramatic reduction of Yellow and Red projects over six months and a 2% increase in overall margin due to focus on financial performance. In addition 90-day late payments showed dramatic reduction over a six-month period due to attention and focus on this metric by the project managers. This system has allowed the organization to monitor all its worldwide operations based on one set of critical success factors and deliverables. The process mapping technique has led to a worldwide uniformity in the operation. It also demonstrates clear and concise performance metrics to potential and current clients.
The three key areas that allow for Metric Prioritization include deliverables, key numeric variables, and the process methodologies that were previously discussed in this paper. The use of this system has provided optimal project management for multiple projects at this CRO. The web will allow inputs from almost anywhere in the world with analysis and control at a central location. The strength of the PMSys comes from the integration of all the disciplines necessary for project management in a clear concise manner. This methodology facilitates posting results to provide visibility of continuous improvement efforts. In summary, the goals of the organization are protected and all business practices are satisfied.