IMPL E ME N T ING CL IN IC A L T R I A L M A N AGE ME N T SYS T E MS

QUICK GUIDE TO PLANNINGYOUR CLINICAL TRIAL

MANAGEMENT SYSTEMIMPLEMENTATION

ABOUT THE AUTHORParam Singh has been working in the life sciences industry his entire career. As the director of clinical trial management solutions at Perficient, Singh leads a highly skilled team of implementation specialists and continues to build lasting relationships with clients. He has a knack for resource and project management, which allows clients to achieve success. Prior to joining Perficient (via BioPharm Systems), Param guided the clinical trial management group at Accenture.

INTRODUCTIONClinical trials account for the majority of the cost in new drug development – a cost that is constantly increasing. Not only are clinical trials expensive, but they are lengthy, complex and highly scrutinized. Technology solutions play a significant role in helping life sciences organizations oversee these critical tasks.

A clinical trial management system (CTMS) is a single centralized software system for the management of all clinical trials. It eliminates disparate spreadsheets and databases across trials, provides access to clinical trial information in real-time, and enforces consistency of administrative, operational and financial aspects of trials across an organization. The CTMS can be used by multiple business units or clinical research divisions within a company, making it beneficial for sponsors, contract research organizations (CROs) and academic medical centers. This system can be implemented organization-wide using a big bang approach or rolled out using a phased approach.

When an organization takes a strategic approach to selecting an appropriate CTMS and implementing it properly, the result is an organization that reduces trial-related costs, increases trial management consistency and efficiency, streamlines clinical trial management and increases clinical research productivity. Perficient’s dedicated life sciences practice specializes in a full range of CTMS services from consultation through implementation.

CLINICAL TRIALS COST ARECONSTANTLY INCREASING

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SIGNS THAT A CTMS IS NEEDED

Key indicators of the need for a CTMS include rapid organizational growth or an increased clinical trial pipeline as a result of a recent or planned merger, increased number, size or complexity of trials, or the introduction of, or increased participation in, global trials.

These situations typically result in a corresponding need to improve the efficiency and turnaround times of clinical trials and to provide access to real-time trial information. If a strategic plan is not put in place to address outdated trial management techniques, it becomes increasingly difficult to quickly and accurately provide trial information.

The continued use of a homegrown management system or disparate methods of study tracking can result in the inability to compare and contrast similar trials, lack of standardization for information that is tracked, conflicting information for the same contacts or organizations, and the inability to track metrics across trials.

BENEFITS OF A CTMS

A CTMS enables you to enforce organizational standard operating procedures and work practices and eliminate individual approaches to trial management. It also lets you utilize a single database with access controlled by security roles and settings, and to use referential data that results in less time spent on data entry and consolidation.

Internal and external integrations have become increasingly critical to today’s clinical trial industry. Organizations want to be able to integrate trial management systems with other applications such as internal customer master systems, document management systems, electronic data capture, interactive voice response, clinical data management, safety and pharmacovigilance, financial systems and more.

To justify and maximize IT expenditures, organizations want easy access to dashboard reports that compile information from multiple sources. They want to reduce the amount of double or triple data entries by having multiple systems talk to one another and share key information such as contacts, accounts, addresses, subject visit information, adverse event details and more.

PREPARING TO EXPLORE CTMS OPTIONS

A good bit of internal analysis and preparation must be performed to build a business case for a CTMS. A company must first understand its current trial management processes and identify various pain points and perceived gaps. As you perform this analysis, take time to really consider what role the new CTMS will play in the organization and which groups of individuals and functional areas will be affected by the implementation.

You also should identify key business and IT resources for the CTMS project core team. At a minimum, the core group should consist of a strong project manager, a business lead, a technical lead and a validation/QA lead. Recognize that these individuals will be involved in all aspects of the project preparation, implementation and roll-out. A key success factor for the project will be the quality and quantity of communication that is provided within the project team and to the end user community.

Before approaching potential CTMS vendors, you should create a system requirements specification document, detailing and prioritizing system requirements by department and functional area. Any potential constraints (e.g., virtual private network access, firewall issues, etc.) and additional functions (e.g., migration services, integrations, etc.) also should be identified and documented. Upper management will need a clear picture of the key benefits of a CTMS, an estimated budget and timeline, and an idea of how the expenditure will increase efficiency and reduce costs overall.

DEVELOPING A CTMS SELECTION CHECKLIST

Your project team must become familiar with basic CTMS functionality and terminology through various channels, such as internet searches and webinars. Identify potential vendors and then research the functionality provided by their CTMS. At this point, you should also consider the benefits of a CTMS accelerator versus an off-the-shelf product (reduces implementation costs and timeframes). Read into industry recommendations, visit conferences, and comb vendor websites and product data sheets, paying close attention to the following characteristics:

PERFORMANCEA CTMS should demonstrate consistent performance and response times under repeated tests of various real-world scenarios. This is true for day-to-day performance, querying and reporting. Users don’t have time to wait for the system to respond to various commands. The software manufacture should incorporate tools and techniques to minimize any anticipated performance issues.

SCALABILITYWhen a company starts performing an increased number of clinical trials, the CTMS needs to be expandable, (scalable), in order to handle the increased amount of data tracking. It also must handle larger numbers of concurrent users. It is important to know any potential costs associated with scaling up a CTMS, such as adding additional servers, more user licenses, etc.

KEY CONSIDERATIONS DURING CTMS SELECTIONA robust CTMS is one that can support most, if not all, trial management tasks from feasibility and study startup to subject tracking and provider payments. It also is one that has been coded properly. The system should not completely go down if one issue is experienced during day-to-day production use.

When looking at various systems, you will need to find out what types of customizations, if any, are both possible and necessary. While the flexibility provided by a highly customizable system may be tempting, try to exhibit restraint for the initial implementation. Keep in mind that each customization is going to increase the cost of your implementation and extend the project timeline.

Determine what, if any, data will be migrated from current systems or spreadsheets. Depending on the data source, the data to be migrated will need to meet specific format criteria, which can be a time-consuming exercise especially if data will be migrated from multiple sources. In addition, it is always good practice to clean the data prior to migrating it to a new system.

In today’s IT environment, most CTMS solutions can be integrated with multiple systems. Several organizations have found that it is best to first implement the base CTMS and then perform one or more integrations as separate phases. This method provides the basic functionality of a CTMS to the end users more quickly. It is also recommended that you analyze the integration method proposed by each vendor. Some methods are more practical than others in that they can be re-used with other applications or vendors.

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THE CTMS CAN BE USED BY MULTIPLE BUSINESS UNITS OR CLINICAL RESEARCH DIVISIONS WITHIN A COMPANY, MAKING IT BENEFICIAL FOR SPONSORS, CONTRACT RESEARCH ORGANIZATIONS (CROs) AND ACADEMIC MEDICAL CENTERS.

CHOOSING ANIMPLEMENTATIONPARTNER

A software vendor may have the expertise to also be the implementation partner, but be sure to explore other options as well. A company that specializes in CTMS implementations will often be more cost-effective and provide a wider range of implementation services that include integration and migration. In addition, a reputable implementation partner will be able to guide you through the computer system validation process if it is required by your organization. Keep in mind that your implementation experience will only be as good as the implementation partner that you select!

CONSIDER POST-IMPLEMENTATION SUPPORT

Each CTMS vendor and implementation vendor should have affordable and flexible options for post-implementation support. This type of support is typically used when an internal support system is not able to resolve a user or system issue. The external support options should include live phone support, email, remote access capabilities and knowledge base availability. The goal of an external support system should beto resolve system issues quickly and effectively.

CTMS EXPERTISE,AT YOUR DISPOSAL

Perficient has a dedicated team that specializes in Oracle’s Siebel CTMS. We provide a wide range of services, including cloud or on-premises implementations, upgrades and integrations. Due to our deep expertise, we developed ASCEND, a pre-configured and enhanced version of Siebel CTMS. Ascend accelerates the implementation timeline and saves costs, since the system contains many frequently requested configurations right out of the box. Our services and solution accelerator have been leveraged by pharmaceutical, biotechnology and medical device companies, in addition to CROs and academic institutions.

TO LEARN MORE ABOUT PERFICIENT’S LIFE SCIENCES PRACTICE, VISIT HTTP://WWW.PERFICIENT.COM/INDUSTRIES/LIFE-SCIENCES

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STAY INFORMEDKeep current with the technology trends, issues and experts by following our life sciences blog.

blogs.perficient.com/lifesciences/

UPCOMING AND ON-DEMAND WEBINARSPerficient experts frequently host technology webinars to discuss the latest enterprise technology trends and share best practice recommendations. All webinars are complimentary.

perficient.com/Webinars

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Visit us at: www.perficient.com or email us at: LifeSciencesInfo@perficient.com

ABOUT PERFICIENT Perficient is a leading information technology consulting firm serving clients throughout North America. We deliver business-driven technology solutions that enable our clients to reach new markets and increase revenues, strengthen customer relationships, reduce operating costs, increase productivity and empower their employees. Perficient is world-class talent, delivering world-class technology, on time and on budget.

Perficient’s life sciences team has extensive experience in the implementation and integration of the most widely used and highly sought-after clinical and pharmacovigilance software applications. We also specialize in the implementation of the leading digital signature solution for the life sciences industry, which can be implemented as a stand-alone application or integrated with various clinical trial software applications. DELIVERING BUSINESS VALUE TO OUR CLIENTSOur services and industry tools enable sponsors and research organizations to get their systems up and running quickly. The results are faster time to value, low and predictable costs, and a better fit for each client’s business.