Empowering Global Medical Information Teams with Software Solutions

Transcription

1 A White Paper Presented By ArisGlobal Empowering Global Medical Information Teams with Software Solutions by Ome Ogbru, PharmD, Medical Information, SME

2 Empowering Global Medical Information Teams with Software Solutions Executive Summary Pharmaceutical Medical Information teams support unsolicited inquiries from healthcare professionals and patients about a company s products. They also support other company departments with information. Pharmaceutical companies have two main activities which are drug discovery and generation of scientific knowledge to support drug development, marketing and sales. Throughout the drug development process and drug life-cycle scientific knowledge is generated through company sponsored preclinical and clinical trials. Investigator initiated studies, pharmacoeconomic studies, pharmacokinetic studies, case series, and review publications also add to the body of knowledge and content that supports the safe and effective use of a drug. Collectively, all the scientific publications and unpublished company data are scientific or medical information. Medical information is what supports the safe and effective use of a product and the marketing of any drug. Essentially, pharmaceutical companies spend most of their resources generating and disseminating medical information through many channels. One of these departments is the Medical Information department. If pharmaceutical companies generate and disseminate medical information and there is a department called Medical Information it seems logical that the Medical Information department would be the global resource for all of the company s scientific knowledge about any of their products. Few, if any Medical Information teams can claim to be the repository of all the company s knowledge about a product. Reaching this level of medical information support requires improvement in several areas. Attributes of High Performing Medical Information Teams High performing Medical Information teams have 3 attributes, * Qualified professionals * Effective processes * An effective global Medical Information software solution Of the 3 attributes listed, selecting an effective global Medical Information software solution is challenging for many teams and is the focus of this paper. For Medical Information teams to create value for healthcare professionals and patients, improve global collaboration, raise the visibility of the Medical Information team, and reduce regulatory risk they need to improve performance in several areas. For example, information that is readily available to them for answering inquiries is limited and it often takes days to develop the right response for inquiries that are not routine. It is advantageous for Medical Information teams to readily have access to all the content needed for supporting inquiries. 2

3 Increasing the value and performance of Medical Information teams requires excellence in 5 key areas: * Multichannel capabilities for inquiry intake and fulfillment * Inquiry management * Content management * System integration * Reporting and analytics Diagram 1: Components of a Complete Medical Information Solution 3

4 3 Strategies for Your Medical Information Solution: I. Complete Medical Information Solution (i.e. ArisGlobal aginquirer, IRMS) II. Modify a CRM, Content Management or Other Solution (i.e. Seibel, Veeva, Salesforce.com), With a Systems Integration Project III. Home Grown Solution Multichannel capabilities for inquiry intake and fulfillment Inquiry management Content management is important for Medical Information teams. Patients and healthcare professionals routinely submit inquiries through and request delivery through electronic means. Other traditional routes (fax, mail, and phone) of contacting medical information are still used but the trend favors use of and other electronic means. Effective medical teams should support all these routes of inquiry request and fulfillment and the process should be seamless and automatic. involves creation of cases, tracking them, collaboration with team members, providing the right response, closing cases, and finding previous cases. This process is central to the job of medical information and should be efficient. Modern software solutions designed specifically for medical information have workflows, robust search capabilities, audit trails, and other features that assist in the case fulfillment process. includes creation of medical information letters and FAQs and the storage and retrieval of several types of content used for responding to inquiries or background information. It involves global collaboration to write, edit and approve medical information letters and other documents. In the past medical information content was limited to medical information letters and prescribing information. More sophisticated medical information solutions also supported storage of articles. In today s world of multimedia, medical information content also includes slides, videos, spreadsheets, journals, textbooks, podcasts, and any other file used as a source document for creating a standard response or for background information. Imagine a content management system that houses all standard medical information letters, source documents, and other relevant content; placing knowledge at the fingertips of all medical information personnel. 4

5 System integration Analysis and Reporting is an important area of focus for IT teams of all companies. Companies are moving away from dissimilar systems that do not support data sharing and collaboration across the organization. Medical Information teams can increase their value and perception by increasing collaboration with other teams. One approach to increase collaboration is seamlessly sharing medical information content with other groups such as Medical Science Liaison (MSL) teams. System integration can also streamline the submission of inquiries through the sales team and reporting of adverse events to pharmacovigilence teams. Modern medical information systems should be built on standard modern technologies used ubiquitously by Fortune 500 companies to facilitate integration with company systems. of medical information data is challenging for Medical Information teams because proper analytical tools are not available. Medical information reports chiefly consist of the volume of inquiries and top inquiries received; they reflect the work load of medical information teams. Deep analysis of medical information inquiries and conversion to more visual formats is mostly a manual and laborious process. Medical information needs better data analysis and visual tools that aide the strategic use of medical information data throughout the organization. Thorough analysis and presentation of Medical information data (coupled with action plans to address any insights or required actions), provides value to the company and more visibility for Medical Information teams Overview of Medical Information Software Strategies What medical information software strategies are used by pharmaceutical, medical device, and biotechnology companies? The most popular medical information software solutions are listed below. Each option has advantages and disadvantages. * Complete MI solutions (aginquirer, IRMS) * Modifications of CRMs and content management solutions (Seibel, Veeva, Salesforce) * Home grown solutions using SharePoint, Seibel and other platforms 5

6 Complete Medical Information Solutions Complete solutions are built specifically for medical information and therefore have features that medical information teams need to get the job done. They have evolved over time as medical information practice has evolved. They are easier to deploy and maintain and require little customization. There are two companies in this category which pass the test for functionality and successful global implementations, namely ArisGlobal (aginquirer) and IRMS, and both should be compared and demonstrated if you desire a complete medical information solution. Below is information and some analysis on each from my experience and research with customers and other sources. A popular and widely used complete medical information software solution is IRMS developed by Online Business Applications (OBA). Although IRMS has many of the features MI teams need, for many companies it falls short in two critical areas: 1. Not web-based so difficult to deploy globally 2. Does not easily integrate with other company platforms These challenges probably stem from the technology used to build IRMS. The legacy IRMS software is a Microsoft Access-based product, a client-server application that runs on Citrix globally and is not an optimal solution for affiliate Medical Information teams across the globe or for remote access. Realizing this challenge OBA launched a lighter web-based version called IRMS-CE for case entry in However, most Medical Information teams need complete systems that are built on modern technologies and are designed for global collaboration. In more recent times ArisGlobal, a leader in Life Sciences solutions released aginquirer. This advanced complete medical information software solution is Cloud-hosted web-based, and built on modern technologies used by most fortune 500 companies. It is the most complete cloud, web-based medical information solution on the market. It was designed for global deployment and it integrates with Salesforce, other CRMS, and company systems. Some distinguishing features of aginquirer versus legacy IRMS include the following: * User friendly interface * Flexible and scalable technology * Ease of global deployment because it is web and Cloud based * Over 140 user configurable fields * Single click audit trails * Single click development of local document from global documents * Built in authoring tool for FAQs and MI letters * Robust content management that supports video, audio, slides, images, PDFs, MS Word, and Excel 6

7 Table 1. Key Features of aginquirer Intuitive and simple interface Web-based, and in the cloud Fast, stable, and reliable Fully configurable, without further development Designed for global collaboration Multilingual support Flexible workflows Create, find, and share content Track cases end-to-end High quality, customizable reports Full audit trail of all actions Meets privacy, security requirements Integrates with CRM, safety, product complaint and other related systems Validated Modified CRM/CMS System Customer relationship management (CRM) systems have components of a complete medical information system but fall short in some areas. They are not medical information solutions but can be customized, through plenty of effort and cost, to deliver some of the other functionality of complete medical information systems. For example CRMs (e.g., Saleforce) used by sales teams may have a contact library but lack multichannel capabilities, content management, workflows, inquiry management and reporting features (see diagram 1) that meet the needs of Medical Information departments. Content management systems like Veeva Vault lack multichannel capabilities, contact library, workflows, inquiry management and reporting features, and integration with safety systems. Customization of CRMs or content management systems consumes department time and is an expensive endeavor. Teams who choose this option must manage software developers, be very comfortable with all phases of the software development cycle, and have a large IT budget for maintenance and upgrades. One advantage of this approach is that other parts of the organization may already be using the same CRM or content management system. Medical information teams should weigh the need for using the same technology offering as the rest of the organization against the cost of customization and using a solution that lacks many features needed for medical information teams to provide exceptional support to healthcare professionals and patients. 7

8 Home Grown Solutions These medical information solutions are built from the ground up using various technology platforms. SharePoint and Seibel platforms have been used by several institutions to develop a custom medical information solution. The challenges of this approach are similar to the challenges for teams that modify CRM or content management platforms. It is expensive, time consuming, and fraught with many hidden challenges. Moreover, the final product often does not meet the expectations of the Medical Information team, necessitating a new strategy in the near future. It may take a year or more and cost several thousand to several million dollars to build and deploy home grown solutions depending on the capabilities of the system. Conclusion Global medical information teams need effective software solutions in order to meet the expectation of customers and deliver value to the organization. Commercially available complete medical information solutions offer the greatest value and are easier to deploy. Many companies opt for home grown or customized CRM solutions when commercial solutions do not meet their needs. Regardless of which approach a company uses, the goal should be providing the best software solution that empowers global medical information teams to collaborate, provide excellent scientific and clinical information, while reducing risk for the entire organization. 8

9 About the Author Dr. Ogbru is a Medical Information Subject Matter Expert at Aris Global. He is also the founder of RxEconsult, a professional healthcare network for sharing healthcare knowledge. Over the last 13 years Dr. Ogbru has held several roles in the pharmaceutical industry, including Director of Global Medical Information and Communication. He has also served as a consultant for WebMD. Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from Dr. Ogbru has written several journal articles and book chapters. In 1997, he shared an award from the American Journal of Pain management for Outstanding Contribution to the Interdisciplinary Pain Management Literature. He is passionate about medical information, online health information, and use of social media to increase health literacy. About ArisGlobal ArisGlobal is the leading provider of integrated solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality and compliance for medical inquiries. Life science companies using ArisGlobal s solutions can better build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world ArisGlobal LLC. All rights reserved. WPTS0214. aginquirer, agtracker, agresponder, agbiblio, 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. 9