Working for a clinical trial packaging contractor certainly has its rewards. If one is fortunate enough, one may witness a new chemical entity traverse the long, arduous climb from initial Phase I study all the way through NDA approval. Knowing that one contributed in some small way brings satisfaction to the work. However, this work is not without its headaches. In particular, project planning and logistics are two beasts that, if not controlled properly, can wreak havoc with a production schedule and ultimately the bottom line of the business.
A common complaint voiced by pharmaceutical development contractors is that no two clients plan alike. Some clients plan so well in advance that one can only imagine how easy the job would be if all clients planned that well. Unfortunately, we are all burdened with clients (luckily they’re in the minority) that wait until the last minute before they realize that they’d better contract out the work if there is any hope of getting the project completed on time. One must tactfully try to break the news that completing the project on time will require a small miracle, as well as a significant cost premium for all of the overtime labor incurred.
Unlike packaging departments within large pharma organizations, contractors do not have the luxury of upper management setting corporate priorities across projects. They must be able to respond and deliver priority service to all clients, regardless of the study size and complexity. It’s easy to say that the size and magnitude of the project determine today’s priority at hand, but large sponsors must realize that the small biotech company now conducting Phase I trials is basing its entire existence on the results of this trial. If successful, the company will eventually be looking for an outsourcing partner to package and distribute its Phase III study.
So, how do clinical trial packagers manage a production schedule that fluctuates from day to day? Will this become a staffing nightmare for someone to coordinate the hiring and training of five temporaries today and 50 next week? Or does one hire the 50 temporaries for the week and understand that there will be times when they will be utilized in packaging and other times will be sitting idle? In regards to profit, inefficiency in scheduling the temporary labor workforce will have a significant negative effect on the bottom line.
What about planning equipment utilization? Obviously, there isn’t an endless amount of bottling and blistering equipment to draw from as the projects come and go.
The answers are all in the planning. And here’s how an organization can go from being reactive to proactive.
All scheduling and planning is assigned to one individual, whom we affectionately call the Master Planner. This individual controls timeline development, schedules projects onto the production calendar and ensures that conflicts in resource allocation are identified and resolved proactively.
Priority 1: Timelines and forward planning. We use an off-the-shelf program (Microsoft Project 2000) to create timelines as the initial quotation is being developed. With each quotation provided to a client, a project timeline is included, identifying all the tasks required to complete the project, always trying to accommodate the client’s expected delivery date. We work backwards from the planned delivery date, setting tasks and milestones along the way, finally arriving at the projected "start of activity" date. This is the date we expect the client to award the project in order to meet the delivery date. During the allocation of production time, we frequently add additional processing days to the timeline so that we can "lengthen" the production cycle should we need to accommodate existing labor Resources .
In the beginning, to easily track and visualize the required labor resources (in units of man-hours), post individual daily project magnets onto a metallic project board. Each planned production room, per production day, will have its own magnet, listing labor and equipment resources required. This should be done for each project quoted even though the projects have not been formally awarded yet.
Priority 2: Defining resources. Contractors must identify the fixed number of permanent packaging operators and Quality Inspectors they are willing to support. This ratio of operators/QA inspectors can be calculated based upon a historical examination of the types of projects packaged within the last year. Categorize the projects into types of packaging: blister packaging, bottle filling and kit assembly. Identify the ratio per type of project. Assume that the mix of projects will remain constant in the coming year. Going by the projected volume of work planned for the next 12 months, determine the total number of man-hours required for both operators and QA inspectors for the year. Divide this number by the production days available within those 12 months (approximately 260). This yields the daily personnel ratio required based upon these projections.
With daily labor resources now defined, the next step is to determine the daily equipment resources available. Equipment resources usually create greater constraints on an operation than labor resources do. New equipment availability normally requires long lead-times given the tasks involved, such as equipment fabrication, delivery, calibration, qualification and validation.
The objective of the "long schedule" is to have a system that uses only existing equipment and your permanent employees, thereby minimizing the need for temporary help. For any future production day, tally the labor and equipment resources required. This number should not exceed available resources. If it does, can the production cycle time of one or two projects be "lengthened," reducing the daily labor resources to an acceptable level? Of course, lengthening the production cycle time can only be an option if this does not adversely affect the delivery date. It all goes back to planning and being able to start the project at the earliest time possible.
One more aspect of Priority 1: Forward Planning. Our business development staff constantly encourages our clients to get the technical services team involved with the planning from the very onset of clinical protocol development. So much planning and work can be performed during this phase: tooling design, sample preparation, timeline development, initiation of an insulated shipper qualification report, to name a few. This valuable "development phase" is lost when the client first requests a bid proposal once the clinical protocol is approved. Our goal during the "development phase" is to assemble a technical package that can be implemented as soon as the project is awarded. Remember that the official packaging timeline hasn’t started yet. Getting all of this upfront work done takes pressure off the client once the project is formally awarded because the client has confidence that sufficient thought and planning has been expended by the outsourcing partner and the timeline milestones are achievable.
The same day as the project is awarded, all components, including tooling, are ordered. The time saved early in the cycle can be added to the production time should cycle lengthening be required.
There is risk involved here, because the client may decide not to award the project to one’s company, the project may be cancelled, or the client may elect to use internal resources to package. The time and cost spent planning and designing components may be for naught. A contractor needs to have the confidence that the majority of projects will be awarded and in the end, the benefits of this program will outweigh the associated costs.
With the project planning and scheduling process now under control, it’s time to improve on the efficiency of the system. Here is where Micro-soft Project plays a vital role.
All timelines created by the Master Planner are linked back to a master cumulative file. With the file link in place, any change made to an individual project file will affect the overall cumulative resource report.
Within Project, resources (labor and equipment) can be defined and limitations established. Should the cumulative daily need of your projects exceed the available resources, the overallocation can be easily resolved through resource leveling.
The software also supports a program called "Microsoft Project Central," in which the Project files are maintained on the company’s intranet (or at a web site). This permits the Master Planner to assign task responsibilities and track project progress across all workgroups. We can send and receive task assignments, task status and task update messages. Project files can include hyperlinks that launch critical documents created in Word, Excel or PowerPoint.
The message for fellow contractors is that effective project planning is key to running a successful business endeavor, particularly one that is so heavily dependent upon labor resources as we are in clinical trial packaging. It is vitally important to implement a process whereby timelines are published at regular intervals throughout the project, are shared with the client and are used to their capacity to predict and control future workload requirements.
Study sponsors must alert their outsourcing partners as early as possible about clinical trial requirements. Contractors need to be involved early while the clinical protocol is circulating internally for comments. Sponsors that plan in this way reap the largest rewards: greater probability that supplies will be delivered on time and a higher quality package, since more time can be devoted to design and work. Also, these projects tend to experience fewer scope-of-work changes (this keeps the project cost down) because the process was given more consideration and definition.