With all the changes underway in the workplace and the market, KM cannot afford--outside of some academic activity--to assume that attitude, because it is not the force behind its own existence. KM is a response to the workplace dynamics and issues we all face, and those workplace dynamics are changing. We are not, as many seem to believe, moving at top speed toward a flatter, more open and democratic management style. Ask anyone who works in an outsourcing situation where things are headed, and he or she will tell you that it is back to strictly hierarchical working methods.
I recently encountered an outsourcing center that measures how many workable minutes there are in the day and how many tasks they expect each worker to complete in the day, then reviews on a weekly basis the worker's performance by second or minute against each task.
We may not like it, but the world of business is a complex and contradictory place. IT vendors and technology service providers have been watching the KM space with intensity over the last few years and have ramped up their activity considerably over the past 18 months. Their attempts at KM fell fairly flat in real terms five years ago, but this time they are more positive. The reason is that their customers are driving this renewed interest, not the KM community. We are seeing demands from our clients to manage all the information a company acquires or produces, structured and unstructured, paper and digital--for that information to be subject to great scrutiny, for duplication and redundancy to be eliminated, and for dynamic business processes to be enabled, to ensure collaboration across the organization, thus reducing costs and increasing efficiency.
Basically, those are the same drivers that have been pushing IT and the economy for most of the past five years. Nothing changed there, but what has changed is the willingness of enterprises to try new things or invest in new technologies. Making the most of their existing investments is top priority.
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So for IT vendors to continue thriving, they need to embrace the new situation and enable more effective and efficient data management for their customers. It is the wave that KM practitioners may also need to ride. IT vendors are rapidly facing up to the consolidation of their industry and the consolidation of many product and technology groups that once stood alone and proud. Of particular interest is the merging of portal, collaboration and content management. Over the past 24 months, we have seen dramatic consolidation in that space at a corporate level, and it is now starting to translate through to technological consolidation, driven in large part by the demands of users.
Collaboration technologies have grown in scope substantially during the last few years. They were once represented by a relatively small collection of technologies--often implemented independently--such as e-mail and discussion groups. The appearance of new components, such as instant messaging and white boarding, simply added to the number of standalone technologies available. We are now starting to see significant collections of tools appearing in single collaboration suites--for example, Open Text's opentext. The wide range of different technologies appearing in those solutions demands a common user interface and some integration to provide a coherent whole.
Many are now exploiting portal-like interfaces to deliver a collaborative workplace, as shown in the figure on page?. Collaboration tasks usually require access to reference material and also generate new content. For that to be managed effectively, you need CM as an integral part of your collaboration suite, and many collaboration vendors are now delivering simple CM. Others have strong links to external CM systems. CM is also moving toward comprehensive suites of tools that cover a multitude of tasks.
Whereas traditional document management, Web CM, digital asset management, records management and a wide range of other content-related technologies were once all independent tools, they are coming together under the enterprise CM ECM banner. We have seen multiple acquisitions over the last two years as vendors have expanded the scope of their software.
As well as managing completed documents, a CM system should also help you to manage the content creation process. Most pieces of content require multiple authors, which means that collaboration tools can be very useful. Collaboration tools are increasingly part of CM systems, frequently through acquisition--for example, eRoom in Documentum and Intraspect in Vignette. The substantial set of multiple CM tools and collaboration functions demands an integrated user interface for effective delivery.
Once again, the workplace portal is being used with increasing frequency. Portals have traditionally been channels for aggregating and delivering content and functions from multiple sources. They are now evolving toward workplace portals, which provide more than just a delivery channel.
The first key step in the process is the selection of an optimal TPO from the TPO pool based on the trial design or program needs. It is recommended that both a primary and secondary TPO choice be made in case the primary TPO choice has capacity issues or competing trials at that time. The selected TPO must be checked and verified for proper qualification dependent on which services are being outsourced.
It is highly recommended that all TPOs or at least the core set of primary TPOs within the overall pool be periodically reviewed and qualified prior to being assigned a project in order to minimize trial startup delays. Periodic portfolio reviews are recommended and as the portfolio and sourcing strategy shifts, the TPO pool and qualifications may need to adjust as well. Next, a request for proposal RFP packet must be compiled for the project.
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The RFP packet must include a draft or final protocol, detailed specifications and operational plan s dependent on the services being outsourced. These detailed documents are critical to ensure optimal TPO comprehension of service expectations, compliance, and ultimately delivery of the key deliverables. Once the final contract and budget are negotiated and executed the project kick off meeting may occur where the operational plan is further discussed along with the development of mutually agreed upon communication and risk plans.
Communication flow is extremely important to ensure that the trials are implemented and managed in an effective and streamlined manner. The flow must also be coordinated and facilitated by one primary function i. Recent publications have reported on a lot of dialogue and activity on many fronts on how to improve overall efficiencies in clinical trials and how sponsors may engage properly with their outsourcing partner s so that efficiencies and cost containment are a priority on both sides.
These interactions optimally need to occur at the portfolio, compound and trial levels in order to ensure logical trial designs and trial placements occur for each compound that makes up the overall sponsor portfolio and to ensure a priority exists on both sides. Most sponsors only interact with their vendors at the trial level.
In order to allow for proactive resource planning, the vendor-sponsor interactions need to occur at the portfolio and compound level. Figure 4 illustrates both the typical and proactive interaction models. Once the project services have been implemented, effective control processes must be put into place to ensure the deliverables are consistently delivered as specified in the contract.
The first control process is efficient TPO oversight implemented in a manner to maximize quality while also minimizing sponsor and TPO staff impact to help control costs. An oversight plan will be needed to ensure consistent implementation across the sponsor staff. Functional areas may need to develop separate oversight plans or a separate section within an overall plan to ensure their unique deliverable requirements are being met.
Effective oversight needs to include both lagging and leading indicators. Lagging indicators would be used to measure historical results telling the sponsor how well the TPO has performed while leading indicators would tell the sponsor if its sourcing strategy is effective and logical. Lagging indicators may include enrollment-to-plan and data-transfers-to-plan, while corresponding leading indicators might be number of initiated sites, countries with FPV, or outstanding monitoring visits backlog.
Clinical processes can start to go wrong well before the TPO performance turns the lagging indicator red.
It is crucial that the right indicators be measured, paired, and analyzed or investigated to tell an accurate performance story—and then acted upon in a timely manner by the sponsor to ensure the TPO is performing at a level to deliver the trial and justify continued inclusion into the select vendor pool. In addition, positive trends need to be continued through shared learning and negative trends mitigated through corrective action preventative action CAPA development. Indicators must be standardized across all TPOs governed by the strategy in order to have fair and accurate cross-TPO performance analyses.
Indicator categories might include site selection, regulatory readiness, enrollment to plan, financial, dataflow, and compliance. In addition, it is recommended that an overall value model be developed and tracked along with the performance indicators looking at not only TPO performance, but TPO service fees and sponsor staff oversight that impact the overall value to the sponsor. The actual TPO service fees may be easily monitored by tracking the TPO invoices while the actual sponsor staff oversight may be tracked using a time entry process i.
The goal of the value model analysis is not to pick the least expensive TPOs, but rather the TPOs with the best overall value. Figure 5 illustrates the typical vendor value model. In order to ensure timely project initiations, the TPO pool must be qualified at all times and ready for use. These reviews could be incorporated into a periodic portfolio review, since the portfolio needs are directly correlated to the TPO pool needs.
Thus, as the portfolio needs shift, the TPO pool would be reviewed, including TPO services, service locations, performance indicators, and need for additional assessments.
Essentials for Developing and Optimizing a Logical Sourcing Strategy
Quality indicators could also be added to the periodic performance reviews as an alert mechanism to the sponsor. These alerts could be discussed at the TPO governance meetings, which are also part of the oversight plan. Similar to performance indicators, excessive governance can be counter-productive, where the resource costs outweigh the benefit to the TPO and the sponsor. Typical TPO governance levels start at the project team operational level, focused on a specific project, and then escalating to the enterprise operational level, focused on multiple projects, and, finally, to the executive operational level, focused on strategic development and efficiency.
All of the levels focus to some degree on relationship development.
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- REACHING THE HEIGHTS.
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Knowledge management—Past and future
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