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PILLARS: Factors to Consider in Selecting a Clinical Trial Disclosure System
A Buyer’s Guide

Provided By

These complexities present organizations with a dual challenge: how to ensure compliance with the changing disclosure requirements of various external registries while simultaneously increasing the e ciency of their internal disclosure practices. but the question for companies becomes how to select the right one. Proactive Disclosure: Clear visibility on compliance dates and responsible stakeholders. While an optimal disclosure solution involves a combination of the right technology and bestpractice disclosure processes within an organization. Registry Mirroring: Complete re ection of all registry rules for real time in-line validation. Accomplishing these tasks using manual systems can be quite challenging as they require tremendous time and nancial commitments to comply with the constantly changing disclosure requirements and updates across the globe. Registry Monitoring: Tracking rules changes and providing rules updates under a service level agreement. Commercial O -the-Shelf (COTS) Software: For rapid deployment. housekeeping tasks associated with trial disclosure. ©2011 Virtify. life sciences organizations are faced with managing the complexities of the global disclosure process. Inc. This last point is the main focus of this Buyer’s Guide and is described as the ve key features of functionality—Five Pillars—that de ne an optimal CTDS: 1. for the purposes of this Buyer’s Guide. and streamlined validation with minimal re-validation. 2. 4. EXECUTIVE SUMMARY In the face of growing regulatory mandates for public disclosure of clinical trial information. evaluation criteria are restricted to selecting a technology-based CTDS.com .Five Pillars: A Buyer’s Guide A CTDS that o ers the Five Pillars of functionality enables users to comply with various international registry requirements and updates in accordance with speci ed timeframes. A technology-based solution known as a clinical trial disclosure system (CTDS) can automate or eliminate many of the tedious. 5.virtify. Global Registries Expansion: System designed for change and support of multiple registries. embedded industry best practices. A CTDS that o ers the Five Pillars of functionality enables users to comply with various international registry requirements and updates in accordance with speci ed timeframes. This Buyer’s Guide attempts to answer that question for companies seeking a technologybased solution by discussing: • The complexities of clinical trial disclosure • Why a CTDS is important • The key criteria for evaluating and selecting an optimal clinical trial disclosure system • The must-have features and functionalities. 1 www. 3.

virtify. government’s repository for disclosure information. and data on the e cacy of drugs.Five Pillars: A Buyer’s Guide …organizations have experienced a near doubling of their disclosure workload with the implementation of FDAAA in the U. There are a host of other disclosure requirements. to submit study information to it. requirements for the State of Maine’s registry extend beyond those mandated federally (http://www.S. The periodically changing disclosure requirements of the various registries place a signi cant burden on an organization’s clinical and regulatory sta to keep pace.com . Some of these country-speci c registries have multi-language disclosure requirements.org/legis/statutes/22/title22sec2700-a.S. As an example of U. COMPLEXITIES OF CLINICAL TRIAL DISCLOSURE Legislative and regulatory mandates from global regulators and health organizations. e. the Food and Drug Administration Amendments Act (FDAAA) expanded the registry’s scope by mandating that life science organizations register selected clinical studies and publish the results of those studies within speci c timeframes. 2 www. clinical operations and regulatory groups are often unable to add su cient resources to handle the resultant workload or to adequately stay on top of various disclosure deadlines. biologics. Australia. and started by requiring all sponsors looking to develop and test new products in the U. the U. beginning in 1997. have dramatically increased public disclosure requirements for all clinical trial activities and their associated results. as described in Table 1. organizations have typically experienced a near doubling of their disclosure workload with the implementation of FDAAA in the U.clinicaltrials. WHO has established a network of international clinical trial registries in countries such as India. For instance. Consequently.gov).S. In 2007. ©2011 Virtify. Similarly. providing improved access to trial recruitment information.S. In Europe. etc. Inc. The intent of these disclosures is to ensure full public awareness of all elements of clinical trials and their potential impact on prospective patient populations. Germany.mainelegislature. World Health Organization (WHO) and European Medicines Agency (EMA). Manual or paper-based processes are typically inadequate to manage the type. the clinical trial application process has been expanded to include a disclosure component with the upcoming release of the European Union Drug Regulating Authorities Clinical Trials (EudraCT) version 8. the Food and Drug Administration Modernization Act (FDAMA) created a publicly accessible registry for disclosure of clinical trials. organizational disclosure processes can be fragmented and out of compliance with disclosure requirements..gov (www. Such awareness includes the disclosure of adverse events. This action was followed by the 2009 requirement for summary reporting of adverse events. breadth and volume of disclosure activity. This registry is the U.g.S.html). and was named clinicaltrials. and medical devices. For example. which launched in 2000. Given spending constraints within the life sciences industry. Food and Drug Administration (FDA).S. disclosure requirements.

nes and negative publicity are consequences of missed disclosure deadlines. Choosing the right partner is not a simple process. Meeting Changing Registry Requirements.Clinical trial regulation. ©2011 Virtify. both in the United States and elsewhere.Identifying and developing a partnership with the right vendor is key to maximizing return on investment (ROI). Developing manual processes. Managing Disclosure to Multiple Registries. Identifying a Disclosure Partner.Disclosure managers often manage disclosure of trial data to several registries.virtify. provides strict deadlines for data disclosure. especially in the United States. As scrutiny increases on disclosure activity.com . Tedious Data Entry.Processes enforced by the trial registries are often suboptimal and require signi cant e ort. can be quite di cult to manage and report. Developing a system for e ectively disseminating that information is also very resource. Tracking and Managing Compliance with Complex Deadlines. Inc. Achieving consistency in registries in multiple languages can be extremely daunting.Deadlines for information disclosure.Keeping track of changing requirements for all global registries is a time consuming task.intensive.Five Pillars: A Buyer’s Guide TABLE 1: DISCLOSURE PAIN POINTS Risk of Missed Deadlines. Increasing Internal Collaboration and Productivity.Disclosure managers are tasked with developing processes without consideration for resources or budget. which promote e ciency and productivity is challenging. 3 www.

How will the CTDS system keep a company in compliance? 2. 4 www. Understanding the importance of the Five Pillars starts by asking pivotal questions. Inc. re-use of information among documents. and a multitude of other features. enable global workflows and increase organizational productivity? 4. (See Appendix A for a list of detailed must-have features of CTDS. Proactive Disclosure 5. What resources are available to support your disclosure processes? How is the support team structured? 8.) ©2011 Virtify. How easily is the system deployed? As companies review the information gathered from the analysis. What are the support requirements? 7. paper-based processes and patchwork alternatives. The right solution can overcome many of the disadvantages of manual. Registry Monitoring 3. A comprehensive technology-based clinical trial disclosure system (CTDS) enables and streamlines the process of posting clinical trial information to the various registries across the globe.com . Global Registries Expansion 4. Does the system allow organizations to adopt an outsourced disclosure model? 5.’s industry experience and knowledge of the regulatory environment. Registry Mirroring 2. they will begin to understand the value of a CTDS system that o ers the Five Pillars of functionality. as described below. Given the impact of correct and timely disclosure on an organization’s reputation and the importance of picking a CTDS that optimizes compliance and e ciency.virtify. a CTDS improves the collaborative environment and productivity of content creation by allowing parallel work ow. How does the system foster collaboration. a thorough analysis of potential systems is essential to select the right vendor.Five Pillars: A Buyer’s Guide TABLE 2: FIVE PILLARS 1. How the system is kept up-to-date? 6. Commercial Off-the-Shelf (COTS) Software FIVE PILLARS OF CTDS FUNCTIONALITY Inherent challenges in complying with changing global regulatory requirements are driving life sciences organizations to consider technology-based solutions that automate the complex process of clinical trial disclosure. such as: 1. How does the system scale to meet international registry requirements? 3. Based on Virtify Inc. there are ve must-haves—Five Pillars—of functionality in an optimal CTDS (Table 2). At the same time.

has more than 5. For instance. PRS added approximately twenty new rules per month in 2010. the disclosure manager should be assured that the posting will be successfully uploaded to PRS without errors that require rework and re-approval. reviewed. The ability to mirror the PRS system is particularly useful because. REGISTRY MONITORING Tracking rules changes and providing rules updates under a Service Level Agreement Disclosure requirements and rules are constantly evolving. This rapidly changing environment makes it very di cult for regulatory departments to stay current. a web-based data entry system for clinicaltrials. 2. As content for a posting is created. The CTDS must accurately mirror each and every PRS business rule in order to ensure an error-free posting. organizations are able to all but eliminate the risk of accidental disclosure and errors. To add to the challenge.Five Pillars: A Buyer’s Guide …based on a Virtify analysis. 1. ©2011 Virtify. based on a Virtify analysis.virtify. and approved. The functionality to mirror a registry allows a CTDS to essentially be a sponsor’s “private version” of PRS. This capability is commonly referred to as in-line validation. Registry mirroring is an important requirement of CTDS because accuracy and comprehensiveness of registry rules directly reduces internal cycle times and the number of work steps to achieve a compliant posting. REGISTRY MIRRORING Complete re ection of all registry rules for real-time in-line validation Registry mirroring is a disclosure solution’s ability to accurately reflect all of the business and data validation rules required by a clinical trial registry. the Protocol Registration System (PRS). fewer re-work cycles. particularly if a manual process is being used.200 embedded business rules that govern data entry into the registry. By allowing users to have a private CTDS separate from PRS. the PRS system lacks the ability to provide instant feedback on the validity of the information posted. which may occur when working in the actual PRS system. has more than 5.gov. For example. In practice. The PRS system generates error messages only upon upload of a complete posting. a web-based data entry system for clinicaltrials. Inc. This results in disclosure managers attempting to memorize hundreds of PRS business rules in order to maximize error-free data entry and minimize rework and approvals. upon data entry into relevant fields. 5 www.gov. the system should provide immediate feedback to the user if the information does not conform to the relevant business rules. as disclosure managers enter information into a CTDS.200 embedded business rules that govern data entry into the registry. including four new elds.a complex multi-step task. these critical updates often become mandatory when implemented by PRS. allowing no lead-time for “catch-up”. This functionality results in fewer errors. The situation becomes increasingly complicated as other registries proliferate within the US and worldwide.com . the Protocol Registration System (PRS). In order to complete a successful posting on PRS. increased usability and high user acceptance. an organization’s disclosure process must ensure that its disclosure data comply with all of these rules . one critical update and three major updates.

com . standards such as Health Level 7 (HL7) Clinical Trial Registration and Results (CTR&R) message for clinical trial disclosure are currently in development. including four new elds.e. Vendors need to have a clear and de ned strategy for inclusion of new regulatory requirements and identi cation and implementation of registry-speci c rules. Similarly. by severity? • Does the vendor have the necessary quality processes in place for software upgrades when using hosted solutions? 3. In order for a solution to both satisfy today’s requirements and grow to accommodate future requirements from many registries. requirements in Europe and India have emerged as top priorities for many sponsors. it is essential that CTDS under consideration be able to quickly adapt to new mandates and changing requirements. it is strongly recommended that the system’s technology architecture be based on Structured Content Management (SCM) concepts. To evaluate a vendor’s capability to comply with the requirement to add requirements immediately. Although the focus of current disclosure systems is the U. i. GLOBAL REGISTRIES EXPANSION System designed for change and support of multiple registries As disclosure requirements grow in complexity.Five Pillars: A Buyer’s Guide Disclosure requirements and rules are constantly evolving. SCM is a new data management paradigm and has distinct advantages when working with disclosure data: ©2011 Virtify. Because new rules generally go into e ect immediately. when evaluating a CTDS. and they are expected to be adopted in the U. PRS added approximately twenty new rules per month in 2010. consider the following: • Does the vendor have subject matter experts who monitor both new regulations and registry-specific rules? • Does the vendor have experience with all of the target registries? • Does the vendor release frequent business rule updates? • Is the vendor willing to issue a Service Level Agreement (SLA) committing to timelines for the delivery of rule updates. Additionally. it is important to evaluate a CTDS’ ability to grow with a company’s requirements. 6 www. It is critical that a CTDS under consideration support messaging standards from various regions as well as registry-speci c data transmission standards. as disclosure requirements proliferate around the world. many companies are seeking to manage disclosure throughout diverse geographies..S.virtify. For instance. one critical update and three major updates..S. Inc. it will be essential that a disclosure solution be able to adapt to changing needs. and Europe.

• It facilitates distributed collaboration by notifying users when changes are made to the trial protocol. It should also easily align with an organization’s internal business work ows.virtify.. conduct. e-signature and noti cations. and have the ability to provide a complete one-click view of all timelines. have the following functionality to enable a proactive disclosure environment: Parallel Work ow: The system must provide collaboration and groupware capabilities to manage both internal and external work ows. it must be able to keep track of timelines across multiple trials. 4. ©2011 Virtify. cost-e ective registry management. Inc. saving a tremendous amount of time and e ort. Also. RBAC enhances productivity by filtering content. review.Five Pillars: A Buyer’s Guide Disclosure requirements and rules are constantly evolving. • It easily supports different registry rule sets. allowing users to easily keep track of related data. the system must provide roles-based access controls (RBAC) to prevent users from accessing unauthorized features or content. • It facilitates data transformations. one critical update and three major updates. In addition. including language translations and mapping between coding systems. increased usability. different rule sets and data types can be applied to content. the amount of work required to keep a posting current is reduced. By linking content together. fewer authoring/review cycles. a CTDS system becomes an active member of the disclosure team and extends the regional disclosure team to the enterprise. including content creation. approval. compliance reporting and tracking In providing a framework for the disclosure process. The ability to collaboratively review and manage comments within the software application is crucial for e ective disclosure process management. It is recommend that the CTDS must. To achieve compliance e ciently. PROACTIVE DISCLOSURE Parallel work ow. By being able to reuse data across postings. For instance. which is not relevant to a speci c user. the CTDS must have a reporting engine with the ability to send scheduled reports and noti cation messages to select users or user groups. including four new elds. versioning. using an executive dashboard or compliance report. or results. enabling key stakeholders to process tasks e ectively. from the system’s user interfaces. PRS added approximately twenty new rules per month in 2010. the ideal CTDS must act as a single platform for global collaboration and management.e. This functionality will provide a dynamic view into all upcoming disclosure timelines. This ensures maximum productivity in the sponsor’s operations with fewer errors. 7 www. i.com . the system must be designed for fast. and high user acceptance. Compliance Reporting: In addition to an integrated work ow. at a minimum. • It maximizes productivity and keeps data consistent.

helps an organization stay abreast of regulatory updates. and does not require costly. reducing the risk of human error. Based on the access permissions and the con gurations made to the system. If the system is built on principles that support future growth and con guration. time-consuming custom development. This analysis will provide insight into how much con guration is supported now and in the future. A COTS system must support both deployment models and a clear path for migrating between models. The system should proactively track these dates and notify the authors of approaching deadlines. off-the-shelf (COTS) solution. it will facilitate scale-up of applications with minimal e ort from IT operations. which includes industry best practices. content-driven work ows.com . notifying and following-up on the tasks and deadlines assigned to various stakeholders throughout the clinical trial lifecycle. Compliance Tracking: The optimal CTDS should assist the posting manager in tracking. 8 www. which are not possible with traditional desktop authoring tools and legacy document management solutions. The optimal CTDS should be a commercial. and streamlined validation with minimal re-validation Adopting new technology and leveraging existing processes and capabilities are not mutually exclusive. Inc. A summary report identifying any issues with a posting must be generated prior to submission to enable management and control of the disclosure processes before the posting manager uploads a posting to PRS. 5. COTS Software Rapid deployment. FDA requires sponsors to publish basic trial results data on clinicaltrials. In evaluating a CTDS. The COTS vendor should be responsive to a company’s evolving needs—o ering a full set of services and support o erings as well as a strong local and global market presence to facilitate global disclosure compliance.gov within one year of primary completion date of the study.Five Pillars: A Buyer’s Guide The CTDS should also be capable of providing stakeholders with systematic review and control of postings to ensure that accurate information is posted to PRS. Assessing the COTS system’s architecture is important in understanding how the system will perform out-of-the-box and whether it can be rapidly deployed with quick system con gurations. responsible stakeholders should be noti ed proactively of posting deadlines.virtify. Several factors that may influence the decision to manage a COTS solution internally or host it with a partner may include: ©2011 Virtify. For instance. it is important to assess the delivery model of the system. State-of-the-art collaboration tools provide essential functionality including exible. if anticipated. embedded industry best practices.

and costective manner. enhancing process productivity and facilitating collaboration in a time. • Number of users • Posting volume • Geographic distribution of users • System management • Data sensitivity • In-house expertise • Organizational strategy Sponsors may choose to implement the software package out-of-the-box or con gure the software’s default functionality to suit their needs. Inc.Five Pillars: A Buyer’s Guide According to the Standish Group.7% of all custom application projects cost 189% of the original estimate provided. a well-architected. 9 www. labor-intensive or complex.virtify. Post-implementation changes to consider are: • Creation and customization of data fields • Configuration of user profiles • Data field mapping • Automated internal workflows • Management of external workflows CONCLUSION The clinical trial disclosure process does not have to be disruptive. The optimal CTDS solution that o ers Five Pillars functionality can provide complete control of the disclosure lifecycle by employing industry best practices for speci c clinical trial submissions approaches and company policies. Specifically. the system should enable the user to perform post-implementation changes to data driven elds in order to ne-tune the operation of the software. In either case. easily deployable COTS solution that is capable of mirroring multiple registries and can easily handle the changing business rules of an array of global registries provides the best chance of increasing disclosure compliance.com . ©2011 Virtify. 52.

virtify. Inc. investigator databases. Provides process controls for the disclosure of quality clinical data. improving productivity. Provide easy “at-a-glance” access to critical process information including progress and deadlines. Annex 11. including clinical trial management systems. Provides a reporting mechanism. which can be used to run best practice reports and custom reports a company requires. Annex 11. Integration with systems. Ensure traceability of data changes and compliance with electronic records requirements including 21 CFR Part 11. etc. Inline validation provides immediate feedback about data quality entered into the disclosure system. Facilitates collaboration. It also provides a global network of best practices experts for consultation. Milestone tracking helps ensure compliance with clinical data disclosure requirements. 10 www. and shortening the disclosure lifecycle.Five Pillars: A Buyer’s Guide APPENDIX A: LIST OF CTDS MUST-HAVE FEATURES According to the Standish Group. Ensure proper accounting and auditability of approval information within the system in compliance with 21 CFR Part 11. and will remain viable in the long term. A system that can rapidly consume rules updates will have longer lifecycle. Increases security by restricting users to perform only the functions required by their job duties.com . Vendor Name:________________________________ FEATURE Rapid Rules Updates Workflow WHY IT IS IMPORTANT Registry rules are constantly changing. and SAS data tables increases productivity and improves quality. etc.7% of all custom application projects cost 189% of the original estimate provided. Improves communication and awareness of distributed teams and key events of users within the disclosure system. and reducing cycle times. productivity. VENDOR CAPABILITY & COMMENTS Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Comments:________ ___________________ ____________________ Inline Validation Dashboards Compliance Milestone Tracking E-mail Notifications Flexible Reporting Integration Roles-Based Access Controls Support Audit Trails Electronic Signatures ©2011 Virtify. This feedback reduces cycles. Reduces time and cost of generating management reports manually. 52. higher ROI. Dedicated global support provides disclosure and system specialists.