White Paper. Technology Spotlight: Leveraging CTMS and Planning Tools for Resource and Capacity Planning

Transcription

1 ArisGlobal White Paper Technology Spotlight: Leveraging CTMS and Planning Tools for Resource and Capacity Planning

2 2013 ArisGlobal LLC. All rights reserved. WP-CR-RCP0213. ARISg, ARISj, agxchangeirt, agxchangeost, agxchangeesm, agxchangersm, agxchangesir, agsignals, agcomposer, agencoder, Register, agclinical, agcrisp, agoutcomes, agsupply, agworld, aghub, agcapture, agdisclosure and the ArisGlobal logo are trademarks or registered trademarks of ArisGlobal in the US Patent and Trademark Office and other jurisdictions. Other marks may be trademarks or registered trademarks of their respective owners and are acknowledged as such. The information you see, hear or read on the pages within this presentation, as well as the presentation s form and substance, are subject to copyright protection. In no event, may you use, distribute, copy, reproduce, modify, distort, or transmit the information or any of its elements, such as text, images or concepts, without the prior written permission of ArisGlobal. Trademarks, service marks, and logos (collectively the trademarks ) displayed on the pages within this booklet, are the property of their respective owner. No license or right pertaining to any of these trademarks shall be granted without the written permission of ArisGlobal, LLC (and any of its global offices and/or affiliates). ArisGlobal reserves the right to legally enforce any infringement of its intellectual property, copyright and trademark rights. Page 2 Aris Global White Paper

3 CONTENTS INTRODUCTION 4 PLANNING TEMPLATES 5 PROGRAM PLANNING 5 STUDY PLANNING 5 DECENTRALIZED/COUNTRY PLANNING 6 CONSOLIDATED PLANNING 6 PLAN APPROVAL 7 TASK/ACTIVITY TRACKING 7 RESOURCE ALLOCATION 8 BUDGETARY FORECASTING 8 SUMMARY 9 ABOUT ARISGLOBAL 10 Leveraging CTMS and Planning Tools for Resource and Capacity Planning Page 3

4 INTRODUCTION Faced with concerns such as increased regulatory scrutiny, the increasing number and complexity of clinical trials, post-marketing commitments, a narrowing drug development pipeline, resource constraints and increased costs, all sponsors of clinical trials are looking to reduce drug development costs by enhancing overall efficiency. Clinical trial costs continue to spiral and often are the result of poor or optimistic planning, which is unable to take into consideration some of the real-life experiences. It is a common expectation that most sites will fail to meet their enrollment rates and many studies will need to be extended way beyond expected timelines. Failing to plan for such occurrences and have suitable mitigation and corrective plans is often a critical failure. Without a holistic view of all clinical trial activity, to be blunt, planning is almost a worthless activity. As such, resource and capacity and effective enrollment planning is becoming more and more important for control and visibility of study costs. This is where Pharma can learn from CROs in terms of resource and capacity planning (after all, we all know that CROs are heavily focused on controlling costs). Today, resource planning models are often maintained in spreadsheets such as Excel, or generic project planning tools like Microsoft project an approach that is often error-prone and inflexible for rapid, accurate clinical trial resource planning. More importantly, the problems are multiplied when planning for multiple clinical trials that run concurrently, often in multiple countries. Without a holistic view of all clinical trial activity, to be blunt, planning is almost a worthless activity. Of course it will likely help in identifying the required resource and the costs, but it can do nothing to validate the viability of the plan itself. And, of course, very few trials run according to plan, with significant delays in the operation of a study. Over the last ten years, Pharma has invested heavily in EDC. However, while EDC offers considerable benefits it can do little to alter the progress and timelines of a trial. There are many activities that must happen in order for a trial to run smoothly including investigator selection, contract management, regulatory approval, essential document tracking and of course patient recruitment. While these can be tracked by a CTMS, it is the role of the study planner to ensure every activity is appropriately scheduled and resourced Clearly, in a clinical trial, resource planning requires the input of different departments. Since it is difficult to share clinical plans, different departments find themselves with conflicting plans and numbers. Reconciling this activity is extremely challenging. Microsoft Project remains the de facto planning tool. In fact, there are few obvious alternatives and it offers a broad array of planning functions. However, it takes an experienced project planner to truly understand the full capabilities the product has to offer, but doesn t help in clinical trial planning. In fact, most planners will touch only a fraction of the capabilities of the system when designing their clinical trial plans; hence many have turned to Excel. However, Excel systems are file based, generally used for a specific study and not centrally available. Further, standard planning formulas, dependencies and visualization tools such as GANTT charts are not available, making accurate and effective resource planning extremely difficult. Page 4 Aris Global White Paper

5 PLANNING TEMPLATES There is often an extraordinary amount of untapped knowledge and experience already available within most organizations. Typically, the activities required to successfully conduct clinical trials are known within the study team, as are the expected duration of activities and departmental/role responsibilities. Of course, many companies will conduct a variety of studies based on the product, either for different study phases or therapeutic area, or with significant differences in the plans required for each study. Using a task planning database, often available as part of the clinical trial management system (CTMS), such as ArisGlobal s agclinical, study planners can build required templates to assist with the studyplanning process. Plan templates will support standardized, common dependencies between tasks, such as start to start and finish to start. the use of study templates that have been specifically derived for the type of study being conducted is an obvious benefit and will provide more accurate planning. Of course, the advantage of a planning database is that multiple templates can be created based on the type of study being conducted. A well-structured template will enable study planners to rapidly create meaningful study plans. PROGRAM PLANNING Most drug companies historically decentralized their approach to capacity forecasting, which made it difficult to coordinate scarce resources. At the program level, the planner can record the purpose of the plan, e.g., the product/compound, therapeutic area and plan type, etc. When creating clinical development plans, templates can be directly copied into a program to form the basis of the new plan. Dates can be refined, resource days allocated and roles assigned. STUDY PLANNING There are a number of ways to plan resources for a study and, generally, most companies would rely on the experiences and estimates derived from previous study activity, i.e., a more top-down approach to estimating study resources. However, this approach is open to significant error as the estimates tend to fail to take into consideration the core differences between the trials. There are many variables that would determine the resource requirements for a specific study and all must be taken into consideration for effective planning. Such variables are invariably available in the CTMS and include indication, therapeutic area, clinical phase, protocol design, number of visits, countries (regulatory approval processes), site locations, CRFs and, most importantly, enrollment rates. So when planning a study, the use of study templates that have been specifically derived for the type of study being conducted is an obvious benefit and will provide more accurate planning. A CTMS can support the study planning process by providing plan templates that are adapted to the type of study being conducted, allowing for different activities to be respected. Any previous clinical activity can be referenced and plans revised. Leveraging CTMS and Planning Tools for Resource and Capacity Planning Page 5

6 Of course, this is also the time to add the granularity required by breaking down the high-level clinical development plan into specific tasks, often by department. Functional roles are replaced with specific trial resources, estimations of effort and planning dates (start/end dates, etc.) are added. Assigning resources at this time can only be effectively accomplished if the availability of resources is known, a task that is practically impossible when studies plans are distributed across multiple spreadsheets. DECENTRALIZED/COUNTRY PLANNING Study plans are further complicated in multi-national studies where individual countries may have specific activities and resource constraints that will have a considerable impact on the planning process. Decentralized planning will enable local country managers to provide more input into the study plan, taking into consideration regional variations such as regulatory obligations. They can also take into consideration data that cannot be accounted for at the central level, such as site locality, resource availability/expertise, and cultural influences. Managers have more control over local resource availability and can clearly plan more effectively and pragmatically than a central planner. As such, decentralized planning will likely give more accurate planning, but it is a time-consuming process to piece together all of the individual country plans into a central consolidated plan. Using Excel, the process is manually intensive, error prone and leads to significant discussion as plans are manually consolidated. Further, regional plans are dependent on study-level activities, so unless studylevel plans are known, the planning process can be even more inaccurate. Again, this is where a CTMS can truly differentiate itself from other project planning tools. Using tools like agclinical, ArisGlobal s comprehensive CTMS, country and site plans can be created and tracked. Central study plans can be referenced, local plans can be refined and resources allocated. Individual plans can be consolidated at both a regional level and at the study level, enabling a far more believable, accurate overall study plan to be created. decentralized planning will likely give more accurate planning, but it is a time-consuming process CONSOLIDATED PLANNING Planning and performing resource allocation for a single trial is one thing. Resources can be assigned with a certain conviction that they are available and can be assigned to the study. Of course, most project planning tools do not have visibility to personnel vacations, so often the fundamental assumptions regarding key resources availability have to be adjusted from the day the plan is shared with the study team. However, planning and resource assignment soon becomes complex when resources are shared between different studies and across geographies. Again, most study planners have very little access to the necessary data to perform effective study planning. As a result, the plans are again unrealistic as necessary resources are not available. Moving from Excel spreadsheets or local project plans to a central database within a CTMS has immediate benefits. Page 6 Aris Global White Paper

7 Some of the most important benefits will be at the early stages of planning when you can specifically identify the availability of key resources. Using a central CTMS, you can easily view all activities associated with a specific resource or role. And when resources are assigned, the system can automatically check to see if the resources are actually available or are assigned to other studies, highlighting potential conflicts and bottlenecks. Similarly, if timelines for other studies shift or planned studies are cancelled, the impact on resource allocation across studies becomes evident. If appropriately used, the study planner will also be able to see vacations of key personnel and adjust plans accordingly. Regional managers can see what activities their team are responsible for and can plan accordingly. Another key challenge is related to the complex hierarchy of a clinical trial, the core of which relates to the countries and sites that participate in the trial. There are crucial activities that need to be tracked at the study, country, and site levels, and there are obvious inter-dependencies with site milestones and activities often dependent on country or study activities (and vice-versa). Accommodating these dependencies in generic tools is practically impossible or would require significant manual effort. However, leveraging a CTMS for study planning enables planners to incorporate activities from all levels by referencing the individual site or country plans. Workflows route the plans automatically between users to provide feedback and comment or make required adjustments all through a seamless electronic process that is fully tracked. PLAN APPROVAL Once a plan has been drafted, it needs to be approved by all respective stakeholders. This can be a broad group of individuals with specific responsibilities. Typically this is currently a manual process with the sharing of Excel spreadsheets and project plans between the study teams. Regional and study planners would work with each department to confirm the validity of the study plan. All changes need to be tracked and plans updated accordingly. The whole review-and-approval process is often a tedious, inefficient process that tends adds significant burden to the study planner. CTMS systems such as agclinical that offer an integrated central planning capability also offer a workflow-enabled review-and-approval process. Workflows route the plans automatically between users to provide feedback and comment or make required adjustments all through a seamless electronic process that is fully tracked. TASK/ACTIVITY TRACKING Once plans have been created and published, it is then important to track the progress of each activity throughout the duration of the study. As such, once finalized, the plan needs to be disseminated to the study team members for tracking. Advanced CTMS solutions such as agclinical send alert notifications (via or an alert) to each study team member upon assignment of a new activity. To ensure a successful trial, study managers need to track the progress of each individual task and identify potential problems early in the process so that informed decisions can be taken. Study managers need to know the status of each activity, especially when activities are late in being initiated or completed and, more importantly, the impact of such delays on other activities in the study plan, e.g., the dependencies between tasks become crucial. Leveraging CTMS and Planning Tools for Resource and Capacity Planning Page 7

8 To do this, individual resources need to document when activities were completed and the central study plan need to be updated accordingly. This is where the traditional planning process fails, as it is extremely difficult to truly track the status of each individual activity and have the study planner manually update a spreadsheet accordingly. The whole process of updating plans and notifying team members of any significant revisions to the plan is extremely cumbersome. In the past, CRAs have seen little or no value in updating project plans and have seen this as a low-priority task. This is an inherent weakness of the incumbent CTMS. However, with more engagement and with CRAs seeing directly how tracking activities impact resource planning, this perception can change. One of the inherent problems or challenges with study planning is in understanding the workload and resource availability of study teams, especially in trials that are conducted across geographical regions. A CTMS application can automate the entire task tracking process. Upon publication of the plan, resources can be automatically notified of activities assigned. Users can use their personalized dashboard to track their tasks. Study team members can update personal tasks, recording when tasks are initiated, updating progress and ultimately recording the actual time/effort to complete activities. All updates in the CTMS are immediately available to the study managers, who can then make necessary corrections to the plan while team members get instant notification of any changes. RESOURCE ALLOCATION One of the inherent problems or challenges with study planning is in understanding the workload and resource availability of study teams, especially in trials that are conducted across geographical regions. Each study member performs a specialized function, and their availability and workload assignment is critical for effective study planning. Combining a CTMS with study-planning tools provides a unique perspective when defining a study plan as the study planner has access to critical planning data, specifically the actual availability of the study team as well as their workload assignment not just within the context of the current trial, but across all trials. With tools such as agclinical, a study planner can look at a specified resource and see their total workload assignment, identify timelines and viewing workload allocation on a day-by-day basis. BUDGETARY FORECASTING The detailed planning of activities can have considerable contribution to the budgetary forecasts. By understanding the individual tasks within a study, the resources required and associated costs,it is possible to get a fairly complete and accurate understanding of the overall resource cost. When defining a specific study role, it is possible to associate standard costs to the role. As such, when defining the study plan and assigning resources,it is possible to quickly build the budget for the resource costs associated with the study. As study teams record actual effort required, it is also possible to get a better understanding of the actual effort required to complete a study activity,which,in turn,can be used to improve future study plans. Page 8 Aris Global White Paper

9 SUMMARY With the increasing amount of trial activity, especially post-marketing combined with growing trial complexity and limitations on resources, it is becoming more important than ever to plan, control and track resources. Without appropriate resource forecasting it is likely that there will be trial delays. Until now, the primary focus by drug manufacturers was on EDC. Hardly surprising, as it is a more tangible assessment. And those promises of eliminating lost revenue are really a carrot. But a trial does not start from database lock, it takes years of coordination and effort by many departments to ensure a trial is successful. The days of relying on best guess are gone and more robust planning tools such as those provided within agclinical will become increasingly important to ensure a successful trial outcome. Trials cannot be closed any earlier and submissions made unless sites have been initiated, regulatory approvals have been given, protocols have been approved, database design has been completed, supplies have been shipped and enrollment targets have been made. And this can only happen if the appropriate planning and resources have been allocated. So, in some ways, it is a mystery that trial planning receives so little support and scrutiny. A CTMS that combines effective trial planning will provide all the necessary data to ensure plans are developed as accurately as they can be. Plans will obviously change, tasks will obviously extend and resources will come and go. But effective planning will help to identify the risks and challenges and provide more realism in the activities and resource activities required. The days of relying on best guess are gone and more robust planning tools such as those provided within agclinical will become increasingly important to ensure a successful trial outcome. Leveraging CTMS and Planning Tools for Resource and Capacity Planning Page 9

10 ABOUT ARISGLOBAL ArisGlobal ( is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. Hundreds of life science companies rely on ArisGlobal's advanced solutions for maintaining regulatory compliance, workflow automation, improving operational efficiency and easily sharing information around the globe. Specific to clinical research, Total Clinical, our integrated eclinical portal, improves the execution of clinical programs by focusing on "smart integration" across core clinical systems electronic data capture (EDC), clinical trial management (CTMS), and clinical safety. This integrated portal provides access to the solutions offered by ArisGlobal as well as to third-party systems from other technology providers. While each solution can be deployed independently, when deployed together, Total Clinical offers a comprehensive and integrated platform for clinical research and safety. Clinical Operations agclinical is a versatile CTMS that enables Sponsors and CROs to plan, track and control all tasks related to clinical trials management. agdisclosure is an advanced solution to support the submission of clinical trial data to the public registries. agxchange SIR is an advanced reporting system that automates the distribution and tracking of clinical safety reports to investigators. agworld is an integrated eclinical platform providing single sign-on access to all eclinical solutions, including 3rd-party vendor applications with consolidated metrics, milestones and KPIs from all systems delivered directly to your dashboard. Clinical Data Management agcapture is a cost-effective, comprehensive EDC system to capture, clean and report clinical trial data. agoutcomes is an advanced electronic patient reported outcome (epro) system that can be fully integrated with a traditional EDC study. This integrated portal provides access to the solutions offered by ArisGlobal as well as to thirdparty systems from other technology providers. agsupply is an integrated IWRS, randomization and supply management system that manages the entire clinical supply life cycle. agencoder is a centralized dictionary coding tool that enables fast and consistent coding of medical terms. For more information on ArisGlobal solutions, visit Page 10 Aris Global White Paper

11 CORPORATE HEADQUARTERS ArisGlobal, 1266 East Main Street, Stamford, CT 06902, USA Tel: Fax: UNITED KINGDOM ArisGlobal UK Ltd, 5-6 Shenley Pavilions, Chalkdell Drive, Shenley Wood, Milton Keynes MK5 6LB Tel: Fax: BELGIUM ArisGlobal BVBA, Groote Steenweg 323 B-2600 Berchem, Belgium Tel: ITALY ArisGlobal GmbH, Via degli Ausoni 7/a Palazzo della Cerere Roma Italy Tel: Fax: GERMANY ArisGlobal GmbH, Inselkammerstrasse 11, D Unterhaching Tel: Fax: INDIA ArisGlobal Software Pvt. Ltd. SKR Towers, # 19/2, 15th Cross, JP Nagar 4th Phase, Dollars Colony, Bangalore , India Tel: Fax: JAPAN ArisGlobal KK, TK Shin-Toshin Bldg., 6F1-23-1, Nishi-Shinjuku, Shinjuku-ku Tokyo, Japan Tel: Fax: IRELAND ArisGlobal Ltd, Embassy House, Herbert Park Lane, Dublin 4, Ireland Tel: