White PapersThe Life Sciences industry is one of intense competition and evolving regulatory compliance standards. Companies constantly face significant pressures to lower the cost of drugs, bring products to market more quickly, and increase profitability. At the same time, companies must maintain strict compliance with regulatory guidelines and improve the level of customer satisfaction.
The applications used in call centers also need to interface with applications that support other types of customer interactions so that the company can establish a holistic view of all customer touch points, a capability that has become mandatory as the result of legal and regulatory requirements.
Medical Call Center Applications The Next Generation The Convergence of Customer Relationship Management, Electronic Content Management, Risk Management to provide enhanced customer service, functional integration with other departments, and rigorous regulatory and legal compliance. TABLE OF CONTENTSExecutive Summary 1Background 2The Evolution of Medical Call Center 3 Increased Scrutiny of Customer Interaction 4 Increased Scrutiny of Product Safety & Quality 5 The Next Generation Medical Call Center Application 6By Scott Padock and Doug May WHITE PAPERCopyright 2006 by RWD Technologies, Inc. All rights reserved. All trademarks, service marks, trade names, and copyrights are proprietary to RWD Technologies, Inc. or other respective owners that have granted RWD Technologies, Inc. the right and license to use such marks.Untitled DocumentExecutive SummaryThe Life Sciences industry is one of intense competition and evolving regulatory compliance standards. Companies constantly face significant pressures to lower the cost of drugs, bring products to market more quickly, and increase profitability. At the same time, companies must maintain strict compliance with regulatory guidelines and improve the level of customer satisfaction.The applications used in call centers also need to interface with applications that support other types of customer interactions so that the company can establish a holistic view of all customer touch points, a capability that has become mandatory as the result of legal and regulatory requirements.While most departments within Life Sciences companies have indirect contact with the consumer of their products, the Medical Information organization typically communicates directly with health care profes-sionals and consumers in the public domain. The Medical Communications group is critical toclient satisfaction and is often the first point of contact for issues that may be subject to regulatoryrequirements. Increasingly, leaders of Medical Communications organizations are called on tocontribute to bottom line objectives by increasing customer satisfaction and using technology to directly support comercial objectives.Successful companies will take advantage of available call center technology solutions to nurture strong customer relations, break down functional and technology barriers to efficient operations, and maintain compliance with ever-evolving laws and regulations.1Untitled DocumentThe Next Generation of Medical Call Center ApplicationsBackgroundFor decades, pharmaceutical companies have had medical communications departments andmedical call centers to field and respond to product information requests from healthcare professionals and consumers. Traditionally, the people in these departments considered themselves to be first and foremost medical professionals; their mission to answer product questions, ensuring that the answers were medically sound, fair and balanced, and provided in a timely manner. They saw their value inensuring that healthcare professionals understood the risks and the benefits of the product andprescribed it appropriately, with unwavering concern for patient safety. They did not see themselves as customer relationship managers, nor did they acknowledge playing an important role in the commercial success of their companies products. In fact, in most companies there was a solid wall, and often a strained relationship, between the medical communications departments and the sales and marketingcomponents of the companies.It is not surprising, given this background, that when medical communications departments began using technology to track and manage product queries and responses, the applications were built to be questioncentric, and a new case record was created for each new incoming query. The question formed the center of the data model and its attributes included information about the requestor, the chemical and brand name of the product, its dose form, the name of the sales representative involved, and the answer that was provided. Over time, a particular requestor might appear repeatedly across multiple records, but these applications provided no way to see other types of interactions with that same person. The medical communications application kept track of the question being asked and the response being provided nothing more. 2Untitled DocumentThe Evolution of Medical Call CentersIn the past decade, there has been a significant evolution of the medical communications function and the role of the medical call center in most companies. Three primary forces have driven this evolution: " Changing expectations about the appropriate role and contribution of medical communications to the achievement of company business objectives; " Intense legal and regulatory scrutiny of pharmaceutical companies interactions with healthcare professionals under Healthcare Compliance guidelines and laws; " Regulatory pressure for holistic management of product safety and qualityissues.These drivers have created demand for a whole new generation of call center applications that can provide a level of functionality and integration with other systems that was unthought-of in the past. The medical call center and the medical communications department act as a primary clearinghouse for the dissemination of both on- and off-label product information in response to product information queries. They have also assumed an important role in building and nurturing strong relationships with customers, thereby making them key contributors to the company s product commercialization objectives. At a time when sales representatives struggle for mere seconds of a physician s time, the professionals in medical call centers interact with these same physicians daily and provide them a valuable service that is directly related to enhanced patient care. Companies naturally want to take maximum advantage of theseinteractions to solidify relationships with these key customers.Changes in desired reach and perceived value of medical information have also changed the roles of medical communications professionals. They have always been called on to author standard response letters and other medical information content to support the call center, but now medical information professionals are responsible for creating an array of medical information products to supportinteractions with new types of customers. For example, medical information scientists develop the Formulary Submission dossiers that form the basis for decisions made by Managed Care Organizations (MCO) and government entities like Medicare and State Medicaid agencies regarding which drugs to include on their formularies. Similarly, medical communications professionals create product informationpresentations that are used by Science Liaisons to support product discussions with medical thought leaders. Tier 1 medical call centers, typically referred to as customer contact centers, are even being used proactively, with out-bound calling initiatives supporting disease management and patientcompliance programs, both of which are directly related to product commercialization strategies.The medical communications function within the pharmaceutical industry has evolved from a purelyscientific activity in support of individual healthcare professionals to a customer care activity with a broad-er outreach, and focused on a far wider customer base. Pharmaceutical companies that canprovide superior service to all their customers, timely responses to information requests, and3Untitled Documentimmediate access to critical information will benefit from better-informed healthcare providers, moresatisfied managed care customers, and more loyal consumers. Not surprisingly, as the medicalcommunications function and the role of the medical call center have evolved, the computer applications supporting them have also undergone a dramatic evolution of their own. Instead of the old question-centric applications, today s state-of-the-art call center applications are true CustomerRelationship Management (CRM) applications in which the customer is at the center of the data model.In addition, call center applications are now integrated with sophisticated content managementapplications and XML authoring, rendering, and publishing tools. These robust content tools streamline the process of assembling response packages to medical product queries, thereby enhancing customer service in the medical call center. However, these same tools have become essential enablers of the expanded medical information acquisition, management, and dissemination functions of the medical communications department.This department must be positioned to provide, on demand, a wide range of medical informationproducts to many types of internal and external customers through a variety of fulfillment channels that are increasingly being prescribed by the customer. Leading practices in content authoring andmanagement employ strategies for chunking content at a level of granularity that supports maximum reuse of content objects. The identical item of content might be used for such diverse purposes asanswering a question in the call center, and developing an informational presentation for a ScienceLiaison. In the past, much of the content was either not visible or not accessible, so there was very little reuse. Now, companies can eliminate significant waste and redundancy while enhancing the value of their medical information assets by adapting practices to manage reuse of content.Finally, the applications used in call centers need to interface with applications that support other types of customer interactions so that the company can establish a holistic view of all customer touch points, a capability that become mandatory as the result of legal and regulatory requirements. Increased Scrutiny of Customer InteractionsAll interactions between a pharmaceutical company and its customers, including those that take place in the medical call center/customer contact center, are subject to intense scrutiny to insure totalcompliance with laws, regulations and industry guidelines governing interactions with healthcareprofessionals. The current scrutiny stems from many examples of inappropriate, unethical, or illegalpharmaceutical company interactions with healthcare professionals. In the past seven years, the industry has paid more than 3 billion in fines for violations of Federal antikickback statutes, the Federal False Claims Act, State laws on the promotion of pharmaceutical products, and the Food, Drug, and Cosmetic Act the primary Federal Law that regulates the pharmaceutical industry.4Untitled DocumentIn the wake of these egregious violations, the Office of Inspector General (OIG) of the U.S. Departmentof Health and Human Services issued Compliance Program Guidance for PharmaceuticalManufacturers. Sometime earlier, the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary trade group representing the pharmaceutical industry, published a voluntary Code onInteractions with Healthcare Professionals and encouraged all member companies to comply with it.In 2005, the OIG Guidance and the PhRMA Code were codified into a law in the State of California that became effective on July 1, 2005. To summarize the guidance and laws, they converge to require companies to monitor and report on all interactions with healthcare professionals. In this case, the term healthcare professional has been given the expanded definition that includes: purchasers, benefit managers, formulary committee members, group purchasing organizations, physicians and allied health care professionals, and pharmacists any person or entity in a position to generate federal healthcare business. Since interactions with these persons and entities take place in many different parts of the company, compliance with the new laws requires an entirely new approach to the design ofcustomer-centric systems.The departmental boundaries that have traditionally defined the functional and technology silos incompanies can no longer limit systems. Instead, companies must develop new unified processes and enterprisewide monitoring and reporting systems to replace the fragmented processes and siloedinformation technology applications of the past. Increased Scrutiny of Product Safety and QualityIncreased regulatory scrutiny of product safety and quality issues is another development that has had an impact on medical call centers and the computer applications that support them. Regulators have made it clear that pharmaceutical companies must holistically manage customer contacts that result in adverse experience (AE) reports and product quality complaints, so that correlation and trend analysis can be car-ried out. This, in turn, creates a need for functional and technical integration among themedical call center, where AEs and product quality complaints are often first received, and the drug safety and quality assurance departments where those items are evaluated, analyzed, and reported upon. The following is an example of scenarios that occur in pharmaceutical companies every day.The medical call center receives a call inquiring about the proper way to administer a topical treatment. In the course of the conversation, the caller also asks if it is common for the ointment to cause a rash that persists for several days. Immediately, the call center representative knows that this product inquiry has now spawned a potential AE report. From the U.S. Food and Drug Administration s (FDA)perspective, it has also spawned a potential product quality complaint, as the rash may have occurred because the ointment was somehow adulterated during manufacturing or packaging. In fact, the FDA has 5Untitled Documentrecently made it clear that the agency considers every AE report to be a potential product quality issue and that companies must be able to do correlation analysis between AEs and quality complaints. Thus, the original product inquiry has now morphed into three items a product inquiry, an AE report, and a product quality complaint each of which must be evaluated and resolved by a different department. A record must be created in the call center application to manage the response to the product inquiry while the other items must be routed to the other two departments. In most companies, routing to the drug safety and manufacturing quality groups would be manual or would merely be a telephone transfer, and medical communications would probably receive no feedback about the ultimate resolution of the items. The problem with this arrangement that has been highlighted by the FDA is that there is no holistic view of these important customer interactions and no way to assure that every item is routed properly, adjudicated in a timely manner, and that all required reports and corrective actions are completed.In other words, there is no systematic protection against an item falling through the cracks, nor is there any ability to perform correlation and trend analysis across AEs and product quality complaints.To address this situation, companies are beginning to acknowledge the need to provide functional and technical integration among the medical call center, the pharmacovigilance department and themanufacturing quality group, and among the technology applications that support these groups. One important component of this integration is the creation of a unified contact database, sometimes referred to as a customer master, from which it is possible to see a holistic view of customer interactions with all parts of the company. Another component is a unified complaint database that captures information from the three separate applications to provide clear evidence that all customer contacts and related AEs or product complaints can be related to one another and that each item is managed to a proper resolution. The Next Generation of Medical Call Center ApplicationsClearly, the medical communications function has changed dramatically in the past ten years. New demands for medical information from a larger and more diverse customer population and the need to receive information requests and disseminate information via a wide variety of channels make it clear that the new generation of medical call center applications will need robust functionality that was unimaginable only ten years ago. Some key requirements and features of the new call center application are as follows: - Customer Centric Case Management. The call center application should be based on an enterprise-class CRM platform that works in conjunction with other CRM components to provide the RWD Technologies. Copyright 2005. company with a holistic view of the customer. - XML-based Content Authoring and Publishing. The application should take advantage of the power of XML authoring and publishing tools to streamline the development of medical information content, maximize content reuse, and 6Untitled Document provide precisely the content needed to satisfy the demands of each medical information consumer. - Enterprise Content Management. The application should incorporate full content management functionality to ensure the security and version control of all medical information assets and streamlined ability to retrieve and assemble content objects to create medical information products to serve both internal and external customers. - Ease of Use. The system must offer a user experience that simplifies navigation and is optimized for the capture of essential data while the call center representative is engaged with the requestor on the phone. - Scalability. The system must be scalable to accommodate increases in call volume that result from the launch of new products and the commercial success of the entire product portfolio. - Enterprise Capability. The system must easily integrate with other systems within the organization, including fulfillment options, printing options, fax delivery, computer telephony integration (CTI), and external interfaces to other applications that capture records of customer interactions. - Supportability. The system must be maintainable by the organization support structure and not require expensive maintenance and proprietary knowledge from vendors. - Compliance Readiness. The system must incorporate features to support validation and compliance with 21 CFR Part 11, the FDA regulation on Electronic Records and Signatures. - Confgurability. The system must be flexible enough to accommodate the unique nomenclature and business rules of the organization. - Triage Functionality. The system should allow for triage of incoming calls by a Tier 1 contact center and routing of calls and call data to Tier 2 medical communications groups or to other departments in the case of AEs and product complaints. - Response History. The system must maintain complete case histories and audit trails, and provide for rapid and efficient retrieval of archived responses packages. 7Untitled DocumentSummary Traditional roles and responsibilities of medical communications organizations in life sciences companies have changed dramatically in the past decade, and they continue to evolve today. The changingmarket landscape and the changing face of the customer are creating a demand for new types of medi-cal information products and new methods for information dissemination. Accordingly, the new generation of medical call center applications truly represents a revolutionary advance in the delivery of customer service, lifecycle management of medical information content, and management of the risk associated with customer interactions. Successful companies will take advantage of available call center technology solutions to nurture strong customer relations, break down functional and technology barriers to efficient operations, and maintain compliance with ever-evolving laws and regulations. For more information, please contact:RWD Technologies, Inc.5521 Research Park DriveBaltimore, MD 21228Telephone: 888-RWD-TECHE-mail: pharma@rwd.comWeb site: www.rwd.comAbout the Authors:Scott PaddockRWD Senior Vice President & General ManagerPhone: 410-869-1028spaddock@rwd.com Doug MayRWD Director of Business DevelopmentPhone: 410-869-7065 dmay1@rwd.com8Copyright 2006 by RWD Technologies, Inc. All rights reserved. All trademarks, service marks, trade names, and copyrights are proprietary to RWD Technologies, Inc. or other respective owners that have granted RWD Technologies, Inc. the right and license to use such marks.
