Stephen Andrade is vice president and general manager for Siebel Life Sciences, Siebel Systems, Inc., 2270 BridgePointe Parkway, San Mateo, CA 94404, (650) 295-5000, fax (650) 295-5111, email: sandrade@siebel.com.

Stephen Andrade

As the number and complexity of clinical trials grows-lengthening clinical trial durations and raising costs-sponsors and CROs need a way to streamline trial management, shorten study durations, and reduce expenditures. Customer relationship management (CRM) strategies update the paper-intensive methods of the past and offer an innovative approach to managing clinical trials-an approach that focuses on strengthening relationships between trial participants, especially investigators and subjects. 		

Figure 1. Products in the pipeline continue to grow, increasing the number of trials and making investigator and subject recruitment more difficult.	

CRM solutions provide processes and tools you can use to enhance collaboration and information sharing among the teams involved in trials. This results in closer, more productive relationships among participants. With these tools, you can also gather and maintain a wealth of data that can be leveraged for a variety of other purposes, such as marketing and sales.	

Here we examine the trends in clinical trials today and describe some ways that companies can meet the challenges raised by those trends. We also list criteria that drug companies can use to select a CRM solution that meets the unique needs of the clinical trial environment.	

Research and development (R&D) in the pharmaceutical industry is consuming more and more time and money. Drug companies spent a whopping $65 billion on R&D in 2000, and the amount increases at a 12% compound annual growth rate.

 Development cycles have expanded from 8.1 years in the 1960s to as long as 15 years in the 1990s. Longer development cycles not only drive up costs but also cut into patent life, shortening market exclusivity. Current spending on trials is about $34 billion per year and is growing at a 10%-15% annual rate. The cost of clinical trials for a successful drug now ranges from $359 million to $600 million.				

Clinical trials consume a considerable portion of R&D time, effort, and money. Each year, drug companies sponsor an average of more than 100 new drug trials. Worldwide, more than 15,000 clinical trials are under way today. Clinical trials under way involve thousands of subjects and doctors at hundreds of medical clinics. As the number of drugs in the pipeline grows because of the convergence of new technologies-high-throughput screening, genomics, and molecular modeling, for example-the number of trials rises (Figure 1).	

About 400 new drugs will advance to Phase 3 trials in the next few years. At the same time, the number of potential investigators and subjects is remaining flat, or in some cases, shrinking. The rapid increase in trials without a corresponding increase in the number of investigators and subjects has made both investigator and subject recruitment problematic.		

Figure 2. CRM systems streamline information flow among clinical trial participants, both internally among clinical operations, sales, and marketing teams and externally with investigators, subjects, and CROs.	

With the increased complexity of clinical trials, the average number of studies per New Drug Application (NDA) has increased from 30 in the early 1980s to nearly 70 in the mid-1990s. The number of pages per NDA has grown from an average of 38,000 in the late 1970s to more than 100,000 in the mid-1990s. The number of subjects needed for each NDA has grown from 1321 in the early 1980s to 4237 in the mid-1990s. Complicating the challenges this presents are reduced pools of potential subjects for each NDA because of more targeted R&D. As a result, drug companies now look beyond their national boundaries to recruit subjects.	

As these trends unfold, drug companies are burdened by conducting clinical trials using the uncoordinated, manual, and paper-intensive methods of the past.	

In today's clinical trials environment, effective logistics management is imperative but not sufficient. A major factor missing from current trial management approaches is effective relationship management. Drug companies need to do a better job of managing their relationships with participants, especially investigators and subjects.				

Strengthening relationships with investigators and subjects can help expedite trials by speeding the turnaround and improving the quality of data, reducing the chance for errors. Faster trials can mean faster time to market.	

Better relationship management can also help solve another major problem-investigator recruitment. Because of the number and complexity of trials, finding and signing up qualified investigators has become highly competitive. Investigator retention can also be difficult in today's environment. One-third of doctors who sign up for trials each year never return for a second trial, which translates into a huge loss of invested knowledge and money.	

To overcome recruitment and retention problems, drug companies need to foster loyalty by building stronger, more personal relationships with investigators. Investigator loyalty can give drug companies a strong competitive edge. Building tighter relationships requires ensuring that investigators have convenient and immediate access to the information they need, when and where they need it-whether it's protocol information or payment status. It also means ensuring that investigators receive timely payments. 	

Subject recruitment is another major issue. The need for human subjects is expected to grow sixfold over the next several years. Today, 27% of clinical development time is spent enrolling subjects. Moreover, nearly 80% of clinical trials fail to enroll the required number of subjects in the time promised by investigators.	

By enhancing its relationships with subjects, a drug company can ensure that the trial experience is a satisfying one. That requires answering subject queries competently and consistently, regardless of how, when, or where a subject contacts the company. It also requires helping subjects comply with trial protocols.	

Customer relationship management (CRM) provides an effective discipline for managing relationships. CRM has been defined as "a business strategy that addresses all the ways that enterprises service their stakeholders. It is based on the ability to facilitate communication and decision-making to provide consistent, high-quality, and cost-effective services to all stakeholders."

 Effective CRM strategies help companies redefine their business processes to be more customer-centered and more efficient.		

Figure 3. Multichannel, investigator-focused interaction ensures consistent and personalized communication regardless of how investigators choose to communicate.				

To be effective, such a strategy must encompass and integrate all customer-facing activities. It should ensure that no matter where, when, or how a customer interacts with the company, the contact is personalized, consistent, and demonstrates that the company knows and values that customer. Business benefits include	

greater customer loyalty as a result of more personal and efficient service.

more effective sales efforts through better management of the sales process.

improved success rates for marketing campaigns through better targeting.

The foundation of a CRM solution is a common data repository that gathers and maintains such information as customer data, product details, and sales and service interactions with customers. Software tools built on this foundation enable an organization's various functional groups-customer service, field service, and sales and marketing, for example-to share and leverage the information in the data repository to improve service to customers. CRM solutions have a workflow management capability that enables an organization to define and track critical processes to ensure that all necessary tasks are performed and completed on time.	

Many drug companies already take advantage of CRM software to enhance relationships with both physician and consumer customers by providing them with better, more personalized service.	

Drug companies can apply the concepts of customer relationship management and the capabilities of CRM software to clinical trials. Begin by thinking of investigators, subjects, and other participants as customers. Sponsor companies can then tighten their relationships with these customers to expedite clinical trials and to improve trial effectiveness and efficiency.				

Consider, for example, the application of a CRM solution to investigator relationships. Using CRM tools, a drug company can gather and maintain a wealth of investigator data-contact information, education, board certifications, and FDA standing. The company can then use that information in a variety of ways-for example, to target recruitment campaigns to the right investigators. 	

Once investigators have been recruited, the CRM solution can provide tools to sponsor and CRO personnel who interact with investigators. These tools tap into the data repository, giving the representatives the information they need to provide personalized and effective service to investigators when they make inquiries or seek help in solving a problem. The representative can view a history of previous contacts and outcomes associated with that investigator. The representative can also search a knowledge base of successful problem solutions to resolve problems quickly.	

The software's workflow management capabilities permit the company to track critical activities with investigators. Drug companies can monitor payment cycles, for example, to make certain that they are performed in a timely manner, and companies can permit investigators to access their payment status directly. This type of support can build investigator satisfaction and loyalty and result in higher rates of retention.	

Companies can also give investigators personalized access to information and software tools that help them in the trial process. Access can be provided through a personalized portal into the drug company's or CRO's information system.	

CRM can also facilitate subject recruitment. Its marketing tools can generate and track recruitment campaigns-for example, to launch and manage a radio-Web subject recruitment campaign. A radio ad can instruct listeners to respond via a Web site. The Web site can prescreen potential subjects by asking respondents to answer a brief questionnaire. The questionnaire can use branching logic, so that the question sequence differs depending on respondent answers to particular questions, such as "Are you pregnant?"	

When the answers qualify a respondent, the respondent can be given the investigator's contact information. To ensure conformity with regulatory guidelines, the workflow management capabilities of the CRM system could be used to mandate approval of the campaign and questionnaire content by the institutional review board (IRB) and other entities before launch.	

Some drug companies are already reaping the benefits of CRM solutions. In three trials conducted in early 2000, for example, Amgen used a CRM system designed especially for clinical trials and was able to reduce investigator payments reconciliation time by 80%. If applied across all 100 of Amgen's trials, that translates into a potential savings of as much as $500,000.

In addition, one of the world's top 10 pharmaceutical companies reports a number of advantages from its use of a CRM system:	

Improvement in the level of service to investigators, such as providing more suitable stocking levels of supplies through process reengineering.

Simplification of administrative processes for planning and reporting.

Improvement in the investigator payment process through integrated payment tracking of sites and investigators.

Improvement of clinical trial progress monitoring through information centralization.

Better planning of subject visits and improved promotion of protocol adherence through visit management tools provided by the CRM system.

Increased productivity of CRAs and their managers through the automation of repetitive tasks and the sharing of information in real time.

These factors enable the company to enjoy more informed decision-making throughout the clinical trial process, leading to a more effective use of resources and faster time to market. That company also reports that the system has enabled it to maintain a sustainable competitive advantage by helping it provide breakthrough service to sites and investigators.	

The collection, maintenance, and seamless flow of comprehensive, up-to-date information is essential for effective CRM, and it provides the foundation for integration across the various business processes. Figure 2 shows how information might flow among the various participants in a typical clinical trial environment.				

Through the system, all participants can contribute and share real-time clinical trial information consistent with the business visibility rules established by each company. As a result, various teams can collaborate more effectively to expedite trials and minimize the risk of costly mistakes. 	

For example, CRAs can establish and track protocol documents for sharing with investigators. CRAs can also update the status of their sites, update site trip reports, and note issues that require follow-up. Site and trial managers can access this information to review trial status and keep studies on track. Investigators can update the status of their tasks to keep CRAs and project managers informed.	

Investigators can also keep their contact and qualification information up to date. Sponsors and CROs can use this information to target investigators for recruitment campaigns. Medical and scientific liaison representatives in medical affairs departments can note investigator interest in trials, sharing this information with clinical operations to use in planning new trials and recruiting investigators for those trials. 	

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As the number and complexity of clinical trials grows-lengthening clinical trial durations and raising costs-sponsors and CROs need a way to streamline trial management, shorten study durations, and reduce expenditures. Customer relationship management (CRM) strategies update the paper-intensive methods of the past and offer an innovative approach to managing clinical trials-an approach that focuses on strengthening relationships between trial participants, especially investigators and subjects.

Stephen Andrade

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