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The dilemma facing clinical operations executives when selecting a CTMS solution to manage clinical trials is to go with an existing approach/solution or explore alternative options.
Managing clinical trials in today’s highly regulated and increasingly global life sciences marketplace can be extremely challenging. It requires an integrated, end-to-end approach that concurrently provides visibility into trial costs and regulatory risks and adheres to schedule. Yet, clinical trial management can be hampered by organizational boundaries, siloed information, disparate systems, and non-standardized processes, resulting in an unsettling case of “You don’t know what you don’t know.” It is important, therefore, that clinical operations executives at life sciences companies address clinical trial management issues proactively and thoroughly to enable successful product development.
For several years, increasing numbers of life sciences organizations have implemented a Clinical Trial Management System (CTMS) that can provide insights gleaned from the system’s data to gain early and increased visibility into problems, progress and possibilities. Many organizations have a constant need to expand CTMS capabilities, integrate clinical operations data across multiple systems, and update clinical trial processes – all in order to adapt to changing regulatory requirements and clinical trial practices. This is the dilemma facing clinical operations executives when selecting a CTMS solution to manage clinical trials – go with an existing approach/solution or explore alternative options.
A typical CTMS defines and manages all of the activities that span the lengthy and rigorous clinical trial process (Figure 1).
Figure 1: CTMS Solution Process Overview
A CTMS can reassure clinical operations executives that “you know what you should know.” It transcends organizational boundaries, improves interoperability, and addresses evolving regulatory standards. It maintains and manages clinical trial planning, preparation, performance, and reporting, with an emphasis on keeping up-to-date contact information for trial participants and tracking deadlines and milestones (e.g., for securing regulatory approval, distributing drug supplies, or issuing progress reports). Typically, a CTMS provides data to a business intelligence (BI) system, which acts as a digital dashboard for clinical trial managers.
A life sciences organization exploring the selection of a CTMS should anticipate the solution to provide the following core capabilities:
In addition, many current CTMS vendors are offering solutions with advanced capabilities for managing clinical trials that are beyond the scope of traditional CTMS solutions. Among these are:
As with any evolving process or technology, implementing a CTMS could result in challenges, such as:
However, the benefits of using a CTMS can be substantial and outweigh such challenges. Potential benefits include:
Life sciences companies have several options for implementing CTMS solutions:
1) Implement an on-premises CTMS from a vendor (e.g., Medidata, Oracle);
2) Enter into a Software-as-a-Service (SaaS) arrangement with a CTMS Vendor;
3) Use a Contract Research Organization (CRO) owned- and managed-system; or
4) Develop a bespoke CTMS solution (a standards-based, open architecture system with interoperable service-based integration with other systems).
Currently, the CTMS market is fragmented and lacks comprehensive, vendor-supplied solutions. While options 1-3 already are being undertaken by various life sciences organizations, we are starting to see the emergence of option 4, bespoke CTMS solutions (e.g., Force.com from Salesforce; Allegro CTMS@Site) replacing entire CTMS traditional software or building a suite of solutions where traditional CTMS solutions don’t meet needs. In addition, we anticipate that the following trends will likely play a key role in an organization’s approach to CTMS selection:
New clinical trial developments. Life sciences organizations will need to understand new developments and approaches such as Adaptive Clinical Trial Design; the implications of managing/executing orphan drug trials; the impact of meeting emerging market needs resulting in global clinical trials; and expansion challenges across countries spanning different IRBs/ERBs.
Technology innovations. Leveraging industry and technology innovations can aid a company’s decision-making when selecting a CTMS implementation approach. These innovations may include CDISC data/information models that have accounted for industry standardization of processes and nomenclature; new platforms (Force.com, Oracle PaaS) to develop CTMS capabilities that aim to keep trial operating costs low while driving more efficiency; and technology-specific enterprise solutions such as business intelligence suites (reporting and analytics), semantic applications, and collaboration/portal suites.
CRO sourcing strategies. Many organizations are using multiple CROs to manage clinical trials. This strategy calls for tighter collaboration among the trial sponsor and CROs and a comprehensive CTMS solution that can align clinical trial processes and integrate eClinical toolset components.
When selecting a CTMS solution, life sciences companies should assess their current and future-state needs, review CTMS capabilities, trends, and challenges, consider the various CTMS solution options, and weigh potential benefits against their clinical operations objectives. Following a CTMS Assessment Framework (Figure 2) can aid the selection process.
Figure 2: CTMS Assessment Framework
** : Bespoke Solutions based on extending CRM solutions OR Platform (PaaS)
The myriad scientific, regulatory, and marketplace changes taking place in clinical trial management are creating a pressing need for innovative solutions that can span and integrate multiple, geographically dispersed trial partners and sites. While traditional software vendors provide CTMS capabilities via on-premises software and/or cloud-based Software as a Service (SaaS) solutions, the possibility of functional and information gaps can be a concern – especially in today’s dynamic life sciences environment. The emergence of PaaS provides an opportunity to reduce these gaps and build a set of CTMS capabilities on a robust, flexible platform that is custom-designed to meet a company’s current and future clinical trial management needs.
Srini Dagalur, PhD, is a Specialist Leader, Life Sciences for Deloitte Consulting LLP. email@example.com