How The Art of Project Management® improved the performance of pharmaceutical clinical trials in a Major Global Pharmaceutical Company

Described in this paper is how BMC assisted a major global pharmaceutical company dramatically improve its performance by introducing cross-functional, project-based management methods, into its global drug development that resulted in ist German Company becoming the corporation’s top performaning global Unit.

A move toward project-based systems

There is an unmistaken trend in management of global drug development to cross-functional project teams who are wholly responsible for taking the drug to market in the quickest possible time. The German Company of a major pharmaceutical corporation wished improve its return on investment (ROI) and productivity of the its clinical development organization and engaged Business Management Consultant (BMC), an global management consulting firm who specializes in such systems to guide them through this change in their way or working. Apart from restructuring the Country clinical development organization, inter-country (inter-Unit) benchmarking was introduced in the parent pharmaceutical corporation that used several “key performance indicators”, e.g., time to market, development cost and data quality. Immediately upon introducing these “key performance indicators” a highly competitive, high-performance culture between global organizational units was created where each unit strived to perform well in the so-called “internal market”.

Restructuring to support project-based management

The restructuring of the German Company involved creating cross-functional project teams that included all functions involved in execution of the clinical trials. In the previous functionally focused way of working, there existed a lack of focus on key tasks by the specialized work forces throughout the clinical trials as well as missing links between complementary functions. This lack of project-focus and missing communications and coordination led to duplication of efforts, incoherent administrative processes, and limited professional skills and consequently a reduction in performance. For the project-based way of working the entire process of national and international clinical trials was mapped, resulting in a master work break down structure (WBS) and network covering the entire clinical trial process from first project approval until the approval of the final medical report with clearly defined roles and responsibilities for each individual critical task, Figure 1. The new management system required a shift in the organizational culture and adoption of a cross-functional project-management culture throughout the company from the Medical Director to the clinical trial team members and their respective management. BMC conducted customized workshops with senior and middle management, project team members and their management throughout the German Company where the basics of the management systems were defined, roles and responsibilities delineated and management actions identified and assigned that supported the restructuring.

Creating the project-based, decentralized culture

It was very clear from the beginning that a project-based way of working should not become only “a technical tool” but rather a key driver of “the new organizational culture”. The new system is marked by ownership, visibility of teams as well as individual responsible people and transparent work processes which warrant professional project planning, tracking and pro-active management. Therefore, the entire line management had to be involved from the very beginning to establish seamless ownership and credibility with respect to the willingness for change throughout the organization.

Training

Conventional project-management courses often only structured technical knowledge neglecting the people-side that is well known to be most critical to the goal achievement in complex, project-based management systems. Therefore, the training was designed to develop a project-based, decentralized system that balanced tools and techniques with leadership skills and the people-side of project management, e.g., cognitive problem solving styles, cultural sensitivities and communications. The Art of Project Management® for Pharmaceutical Projects was customized and based upon assignments derived from the Company’s real-life projects used as case studies.

Reinforcement

Follow-up workshops were conducted 6-9 months after the initial training involving all of the project and line managers who had also participated in the earlier training. The purpose of the Workshops was to:

1. reinforce the newly developed skills through coaching and follow-on training,
2. share experiences and lessons learned while using the newly developed skills, and
3. to continue the development process by identifying areas of needed improvement and the assignment of actions directed toward making further improvement.

Improvement in Performance

During the training, participants performed a self-assessment of how well they were managing their current projects using BMC’s unique Assessment Inventory of Project Management™. This 360 degree Assessment Inventory consists of questions with which individuals score themselves in five basic management functional areas that describe their job: Planning, Organizing and Staffing, Directing and Leading, Controlling and Reporting. The instrument was designed to measure change of performance during organizational development efforts. Participants compared their scores through their development. Table 1 shows both the mean scores as well as the standard variation of the scores at each session.

In all five areas that constitute the project manager's job, the scores improved during the 6-9 months after the initial training. However, perhaps more important was the improvement in congruency and consistency of cross-functional practices 6-9 months after the initial training. BMC has found that without congruency and consistency of practices across cross-functional and cross-organizational teams, maximum project performance is not realized because barriers are created to the natural flow of work, and project team members become frustrated with one another's differing non-predictable actions, vis-à-vis total quality management. This can become serious in international teams where insensitivity to organizational or societal cultural differences may also breed confusion and mistrust. Frequently, if such inconsistency persists after training, it is because each individual place a different priority on whether or not they need to apply the techniques they have learned to their projects. Therefore, for the sake of expediency, the techniques are ignored. A solution to this situation is for their management to require that they to do simple things, such as:

1. creating project execution plans before projects are permitted to begin,
2. encourage simple project management reporting between team members and with their managers,
3. require simple performance metrics such as percent complete, milestone slip and or variances are used and that they be regularly provided to the team members.

During the organizational development effort, the German Company experienced an improvement in the performance of its clinical trials as measured by the global company’s "Dashboard" method of performance evaluation. During the first 12 months of the organizational development effort, the German Company improved its overall relative position dramatically from 13th in the world among other global medical companies to 1st in the world. In brief, not only the contribution of patients in absolute numbers more than doubled during the period but the German Company became the Corporations most efficient Company in terms of patient load and productivity per capita of clinical monitors while the total cost remained maintained stable.

Organizational Support

Although the performance of clinical trials within the medical operations the German Company had seen significant improvement, it was recognized by senior management that there was still room for improvement if better cooperation and communications between the clinical research and therapeutic areas within the medical operations routinely occurred. In terms of organizational maturity, the German Company had established many of the prerequisites for moving from a "functionally-focused" to a "project-bases" where cross-functional projects go on simultaneously in a coordinated way utilizing expertise from across the company and with the full organizational support of the company.

At the "functionally-focused” state of maturity, individuals use basic project management skills within their own functional areas of influence, e.g., cardiovascular, oncology, CNS, dermatology, QA, etc.; however, individuals in each functional area may practice the methodologies differently. This was seen to be occurring early in the German Company’s development and was substantiated by the scatter (variance) in performance data as was seen in Table 1.

To reach the next stage of maturity:

1. the Company must apply project management techniques uniformly across the co-operating areas,
2. priorities must be established and decisions made that are consistent with the overall business interests and strategy of the company by top management for the project teams,
3. key top managers must actively assist project teams by removing barriers that may inhibit the success of the "most important" projects to the organization,
4. one or more key top managers take on the responsibility for appropriate professional development of the project management skills and competencies required by everyone in the company consistent with their particular management responsibilities.

To further identify areas of improvement and create necessary appropriate actions, a Senior Management workshop was conducted containing a top management briefing by BMC describing keys to creating a project-based company (the system of management and organizational culture).

The goals of the Senior Management workshop were to better understand:

• How senior management should continue the development of the project-based system of management and organizational culture in the German Company,
• How senior management can provide the organizational support needed in The Art of Project Management®,
• Senior management's roles and responsibilities within the German Company,
• How to measure the project management effectiveness during the change process.
• What actions should this senior management group take to further improve the development of the German Company.

Results of the Senior Management workshop

In order to facilitate the discussion prior to the workshop, the senior managers were asked to assess their existing organizational support system against 10 dimensions believed to be important in providing organizational support in a project-based company. Table 2 shows the results of the senior managers assessment. Participants were asked to answer 10 questions by placing an "X" in the column corresponding to the extent to which they believed such support was currently being provided. In the workshop, these data demonstrated inconsistent practices that could be a problem and provided focused syndicate discussions on what improvements were still needed in the management system. From this assessment of organizational support, it became apparent that: 1) project planning was not being consistently required by line managers, and 2) competencies associated with project management had not yet become recognized formally as a part of everyone's job from MD to team member, i.e., it wasn't in the people's job description.

The management actions necessary by the senior managers that were identified were:

• Each senior manager committed themselves before their peer managers to insisting that project execution plans would be developed by the cross-functional project team that were approved by the respective managers of various involved functional groups before projects would be permitted to begin.
• A very simple and appropriate planning process was agreed upon to between the senior managers.
• One of the most senior managers volunteered and took the responsibility to review all job position descriptions and to make recommend modifications to include appropriate project management competencies.

Conclusion

After a project-based system of working was installed in Germany Company experienced:

• Faster product-to-market cycle time,
• Increase effectiveness and productivity.
• Gain greater commitment and accountability of individuals,
• Improve creativity, quality of the work and productivity,
• Improved employee and management morale.

The driving force for this remarkable improvement in performance at was the strength and unbridled potential of a cross-functional groups of individuals working together in ad hoc project teams from inception to completion of the clinical trials phase for which they are "wholly responsible" that was support by top the Company’s top management who provided the vision and supported the creation of a management system that enabled the decentralization of responsibility, accountability and control to the project teams.

Table 1 Comparison of mean scores and standard deviation of The Assessment Inventory of Project Management™ scores for individuals in initial training and that of 6-9 months later

Figure 1 Cross-functional project teams in the German Company