22 June 20 08 VIEW on Clinical Operations ECLINICAL I n recent years, the management of clinical trials has become increasing ly complex as the size, geographic diversity, and complexity of trials grows. Managing these highly complex trials requires the study manag er to be in control of a wide range of data. A clinical trial management system (CTMS) serves as the central repository for this information. A CTMS is an excellent tool for organizing the vast array of study man agement information needed to effectively execute clinical trials. Although CTMS tools do not collate the actual data captured during clinical trials, which may be captured through an EDC system, they ensure that all other sup porting clinical development knowledge is maintained in one consolidated electronic system within the organization rather than in the hands of individ ual team members or solely in a paperbased trial master file. These systems — and the potential for the increased efficiencies they can provide — have existed for years.There is no such thing as a “new” CTMS. Even in environments where no formal CTMS exists, many of the functions of a CTMS are in place in various ad hoc spreadsheets and paper files. In other environments, a CTMS has been installed, but the data within the sys tem are not considered trustworthy. Few organizations have implemented a CTMS in a manner that provides a useful tool with excellent data reliability. Organizations commonly make mistakes during implementation of such a complicated and highly customizable system, which can lead to delayed roll out or systems that simply “die” before they are enacted.To ensure the suc cessful adoption of a CTMS, organizations should be aware of the most com mon errors associated with implementation and ways to avoid those errors. Error No. 1: Not Enough Stakeholders An effective CTMS should become the backbone of an organization’s clinical development efforts, as it serves as the central repository for all trial data. Since clinical trials are multifunctional efforts that require the coordina tion of a huge number of specialized functions, the CTMS must be useful to all. Unfortunately, this fact is often not considered when planning a CTMS implementation. In many organizations only the study management function is tasked with the implementation of the CTMS because it is considered the system’s prime user. While study management may meet its own CTMS needs in such cases, they often do not meet the needs of other stakeholders. It is for this reason that buy in is needed from all functions within and related to clinical development. Other primary users (e.g., clinical opera tions, clinical data management, and medical affairs), and secondary users (e.g., finance, IT, regulatory, contracting drug supply, and trial master file man agement) also have needs that should be considered in the implementation of a CTMS. Without buy in from all of the key stakeholders, CTMS imple mentation flounders because nonengaged stakeholders fail to use the sys tem effectively, making it less useful even for those functions motivated to use the system.To ensure collective buy in, clinical development leadership must gather and incorporate the groups’ input into the CTMS implementa tion process. This is most often done by appointing a steering committee, which is comprised of senior leadership from across many of functions associated with clinical development. The committee should ideally be structured as follows: # Executive Sponsor — Vice President of Study Management # Project Sponsor — Senior Director of Clinical Operations # Steering Committee Members — the most senior person in the following roles: biostatistician, data manager, monitor (clinical research associate), study manager, clinical information technology specialist, medical director, senior project manager, information technology spe cialist, and regulatory affairs director. The primary responsibility of the steering committee is to agree on users’ needs for the system and use those requirements to map out the overall CTMS strategy.The first step in creating a successful strategy is hav ing the steering committee members reach out to all levels of the organi zation to understand users’ needs and the benefits desired. Once members agree on the organization’s needs and prioritize those needs (and the sub sequent integrations required), they must select an actual CTMS and map out an operational approach. Error No. 2: Insufficient Alignment of Resources Clinical trial management systems are expensive. While the value they bring should be greater than the expense, there can still be “stickershock” associated with the purchase. Unfortunately, many organizations spend the bulk of their budget on the initial acquisition and installation of the CTMS software, and thus have little left over for the many resources required for implementation success. The complex nature of a CTMS implementation means that resources are required to align system specs with stakeholder needs, manage project logistics, facilitate decision making, support develop ment of working processes and SOPs, and create and provide training. As pointed out in the discussion of Error No. 1, stakeholder involvement in CTMS implementation is a must. One of the most resourceintensive ele ments of this involvement is ensuring that stakeholder needs are gathered, prioritized, and translated into system requirements.These are not tasks that CTMS software vendors are equipped to handle due to their lack of famil iarity with the internal structure of the client organization, which means orga nizations implementing CTMS must dedicate additional resources to these activities. Senior management and experienced linelevel personnel that sup port a specific function should play a role in the implementation process. Across each major functional area and within the various levels of experi ence, organizations should commit a fulltime resource to the system imple mentation for three to six months. In addition, those resources should be available on a parttime basis for a minimum period of three months after the initial implementation to ensure that the system is running smoothly, adding value to employees, and being utilized on a regular basis. Campbell Alliance Avoiding the Five Common Errors Made in Implementing a CTMS Gary Tyson, Vice President, Clinical Development Practice Marybeth Lynch, Practice Executive, Clinical Development Practice 0608 pvv layout FINAL 5/29/08 11:44 PM Page 22 23 VIEW on Clinical Operations June 20 08 ECLINICAL With so many interconnected activities and functions involved, CTMS implementation requires a fulltime project manager to run daytoday activ ities. And it is more likely that the scale of most implementations will require a team of project managers with “subproject managers” driving one or more work stream within the overall implementation effort. In addition to resources to manage the wide range of logistical concerns, organizations implementing CTMS must also dedicate resources to the deci sionmaking process. From the selection of a system all the way to rollout, countless decisions must be made to support effective implementation. Seniorlevel resources must be freed to dedicate the time necessary to resolve issues and come to agreement across various stakeholder functions. Once the decisions are made and the system is configured, the organiza tion must develop the documentation necessary to support system use. CTMS business process and supporting SOPs must be created (or revised) to pro vide the guidance users will need to effectively and efficiently use the system. While CTMS processes and SOPs are necessary, they are only effective if users are familiar with them.This means that organizations must put aside sufficient budget for both the development and conduct of CTMS training in support of rollout. Error No. 3: Competing Visions In implementing a CTMS, challenges surface when the diverse group of stakeholders involved does not share a common vision for how the CTMS will be used within the organization. While each group within clinical devel opment may have its own agenda for implementing a CTMS, a successful implementation should center on a single, common vision.Without this com mon vision, various aspects of the system may be configured suboptimally, or the CTMS vendor may be put in a position where it has to resolve these competing visions — a job that it is not qualified to perform. To prevent such competing visions from having lasting effects on the pro cess, organizations can convene a crossfunctional visionsetting session prior to the start of CTMS implementation to build a common vision that will inform the entire configuration process. A vision can be simply defined by understanding what the organization hopes to accomplish with a CTMS. In addition to informing the configuration process, having a common vision will also support the effective selection of a CTMS solution. Many CTMS options are available — from tools that support the internal building of a CTMS to prefab software solutions implemented by external technolo gy vendors. No matter what type of solution an organization chooses or the level of crossfunctional suppor t, without a common vision, stakeholders may simply not support the system or vendor selected. Given the range of options, the project leadership team must have a clear CTMS vision to ensure the correct technical approach is selected to meet the needs of all functions. Otherwise, there will be tremendous push back within the organi zation as a result of the lack of buy in. Each functional area involved should interview representatives to identify key business requirements for the system, and these requirements should be given relatively equal weight. Once these requirements are identified, vendors should respond to a formal requestforinformation that addresses the various business requirements, and a range of staff should be given the opportunity to score the vendor’s responses. In addition, every effort should be made to include all the various functions that will need to use the system in the ven dor demonstrations. Feedback must be gathered and shared to be taken seri ously as a part of the selection process. Error No. 4: Setting Unreasonable Expectations A primary responsibility of CTMS project sponsors and the steering com mittee is to establish reasonable goals for the CTMS implementation, taking into consideration both timelines and user benefits. While aggressive benefit targets encourage the implementation team to move from simply installing the system to questioning how clinical trial processes and procedures can be improved overall, overlylofty goals can overwhelm an organization and ulti mately have a negative impact on the success of implementation. In short, companies must walk a fine line between aggressive and unreasonable goals. When establishing goals, it is important to remember that while a CTMS may have many different capabilities, it’s unreasonable to expect that all capa bilities will be implemented simultaneously. Organizations that attempt to implement all or even most of the capabilities of a CTMS at once experience significant implementation delays. Instead, they should pick the smallest subset of functionality that will pro vide the most valueadd to the organization.This approach is more likely to result in regular use of the CTMS because it is more likely that those using the system will find the CTMS to be more beneficial that their previous approach. Over time, and once the system has begun to be used more fre quently, organizations can add additional functionality. When implementing such a stepped conversion process, it is important that the organization man age expectations by making their staff wellaware that they are consciously choosing to start with a minimal benefit set. When deciding which benefits to target, it is important to remember that a CTMS feasts on data. It can track tremendous quantities of data, and the temptation is to begin collecting as much data as possible from the start of implementation.The problem with this approach is that little of that data actu ally drives direct benefits for the end users.These dataheavy implementations gain a reputation as being unhelpful, and organizations will quickly start to ignore them. It is better to collect the least amount of data necessary to reach the expected benefits. Error No. 5: Interface Mania As organizations seek to develop and implement an integrated eClinical environment, they tend to seize the opportunity presented by CTMS imple mentation as the basis for pursuing that vision. A CTMS has the ability to serve as a hub of data for clinical organizations, with information from the system feeding EDC, finance, project management, document management, safety, and clinical database systems; however, regardless of the end benefit, it is not in the best interest of the organization to delay the rollout of a CTMS in place of ensuring that the system can interface with all other clinical systems. Instead, additional system implementations should be supported with as much time and resources as were allocated to the original CTMS implementation. Successful organizations often implement a CTMS initially with no or just one interface to ensure that the organization can begin to benefit from the standalone capabilities of CTMS while the remaining interfaces are devel oped. More importantly, interfaces are often invisible to the end user, and thus do not necessarily add value to the organization from the start, which is imperative to the success of system implementation. Additional interfaces can and should be implemented at a later date.This approach also provides organizations with flexibility in creating the interfaces because the organiza tion’s needs will most likely be modified as CTMS is implemented. Implementing a Successful CTMS The process of designing — or redesigning — a clinical development organization’s operations to effectively work with a CTMS is not an easy one. But considering the alternatives — an ad hoc range of spreadsheets and inef ficient paperbased systems — the decision to undertake the effort is a ben eficial one. # CAMPBELL ALLIANCE, Raleigh, N.C ., is a management consulting firm specializing in the pharmaceutical and biotechnology industries. For more information, visit campbellalliance.com. 0608 pvv layout FINAL 5/29/08 11:44 PM Page 23
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Avoiding the Five Common Errors Made in Implementing a CTMS
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