CTMS: What You Should Know

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.

CTMS definition, challenges and benefits

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:

• Clinical program/project management - Enables oversight of related clinical trials per therapeutic area based on a set of specific clinical project activities (i.e., tracking actual vs. target). Includes the ability to track progress at specific trial and program levels.

• Trial and site planning - Facilitates investigator and site identification and recruitment, including key trial milestone tracking such as target site/enrollment metrics for each study country.

• Site and subject management - Provides tracking ability for site monitoring, subject enrollment relative to plan, and Case Report Form (CRF)/ Electronic Case Report Form (eCRF) completion status. Includes management of site visits/trip reports.

• Study management - Tracks key information such as CRF collection, Clinical Research Associate (CRA) monitoring frequency, protocol visit frequency, and adherence to protocol regiments. Includes support for study documentation and tracking tasks.

• Investigator management - Allows the trial sponsor to manage relationships with investigators, based on visibility into the status study data and related status with CROs and/or investigator sites. Also tracks approvals by Institutional Review Boards (IRB) and Independent Ethics Committees IEC(s).

• Study financials and investigator grants and payment management - Supports financial management including tracking study costs, reimbursing investigators, and paying claims related to study activities. Includes grant payment management and management of financial disclosure.

• Clinical supply management including supply tracking - Manages clinical supplies.

• Clinical trial performance and reporting - Provides reporting/dashboards to communicate trial performance against targets, as well as other operational reports.  

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:

• Protocol and study documentation management - Enables review/management and authoring of essential study documents. Also includes approval of clinical trial documentation and tracking its status throughout its lifecycle.

• CRF and eCRF development - Provides the ability to view and track the creation of CRF/eCRF forms including their status.

• Tracking electronic data capture (EDC) components and summary details - Tracks the status of data collected in these forms which, in turn, informs the tracking of key clinical trial milestones (e.g., Last Patient Visit (LPV).

• Financial system integration - Integrates SAP financial systems with pre-existing SAP workflows/business rules for payments, including invoicing approvals.

• Clinical supply management: storage and shipment - Extends clinical supply management to include oversight and management of clinical supply logistics for components such as inventory locations, lots, and shipment details.

• Clinical data archiving/warehousing and management - Provides enhanced data management and archiving for future reference

• Data analysis and query resolution - Supports the evaluation of trial-generated clinical data and resolution of any discrepancies or inconsistencies found in clinical data.

• Clinical learning and training - Integrates learning management to track and manage internal and external staff learning requirements relative to the clinical trial process.

As with any evolving process or technology, implementing a CTMS could result in challenges, such as:

• Data access issues, as data resides in multiple locations or there may be gaps in data collection (i.e., trial process-specific data might not be captured)

• Lack of mature data management capabilities to store current and historical data to aid data analysis

• The inability to respond to potential protocol amendments in a timely manner

• Poor quality and reliability of clinical operations data due to significant lag times between data entry and reporting, and inconsistencies in reference data among various source systems feeding the CTMS.

However, the benefits of using a CTMS can be substantial and outweigh such challenges. Potential benefits include:

• Improved clinical operations decision making resulting from more efficient trial planning/tracking milestones via executive management dashboards and metrics reporting

• Increased trial investigator selection rates and performance tracking management

• Help managing clinical trial costs/payments and clinical drug supplies tracking

• Enhanced relationship management across the clinical trial process (CRO, investigator and sponsor)

• Accurate financial reporting with enhanced ability to manage operations of individual studies and the entire set of clinical programs

• Improved data quality through the use of consistent vocabularies, including dictionaries, to avoid confusion and ambiguity of clinical trial data meaning.

CTMS marketplace trends

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.

How to select a CTMS solution

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)

Summary

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. sdagalur@deloitte.com