EDC Focus: Making the Right Investment in CTMS/EDC

How to evaluate the solutions

By Joseph J. Valeri

Recent industry trends and events — including the passing of the American Recovery and Reinvestment Act, the FDA’s push toward standardization of data formats and the increasing cost of clinical trials and studies — are all leading study sponsors to seek new technologies to improve productivity and optimize efficiency. An effective solution will eliminate redundancies, optimize reuse of trial and study tools and provide an interoperable platform, allowing easy integration with other technologies based on evolving industry standards, in particular the FDA-approved Clinical Data Interchange Standards Consortium (CDISC) standards.

We will provide an overview of the two most common solutions on the market, Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS), discussing the benefits of each, the classes of organizations that offer these solutions and what questions to ask when evaluating a potential partner.

EDC vs. CTMS

While many different technologies have been marketed in the past, the new offerings that can impact trial and study costs are Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems.Recent articles have characterized each as a component of the other as opposed to standalone, interoperable applications. To simplify this discussion, let’s consider EDC to be form- and file-based data collection and CTMS to be the process of ensuring protocol compliance, data quality and meaningful data sets. From this author’s view, EDC is a critical module of a good CTMS application, since the method of data collection is part of protocol compliance.

Electronic Data Capture (EDC)

EDC applications have been around in many forms for several years. Due to the absence of mass market products, many research organizations created simple EDC applications using MS Access, Oracle or other applications. Innovative technologies were also introduced to accept data via fax machines and, more recently, pen-based computers. The EDC implementation with the highest likelihood for success is Web-based EDC, which delivers data collection using Web forms in a standard browser. No matter the method, EDC applications are used to capture clinical site data in a centralized manner to ease data management, validation and analysis.

Clinical Trial Management Systems (CTMS)

CTMS is a newer product category that is used by numerous vendors to characterize very different groupings of functionality. All CTMS solutions should include tools to manage the process of a trial or study to provide oversight for protocol compliance.

Some of the common features of a CTMS are:

• Data form design and approval
• Payment processing/payment management
• Online collaboration
• Document management
• EDC
• Randomization
• Certification and license tracking
• Recruitment tracking
• Visit scheduling
• Reporting
• Enrollment management
• CDISC ODM compliance

Less common features that exist in a few CTMS applications are:

• Bio-repository management
• Image management
• Site visit management
• Gene data management
• Online statistical analysis
• Drug kit management
• CDISC SDTM output

With such a wide variety of features, potential buyers should carefully compile their specific requirements before looking for a CTMS.

Benefits of a CTMS/EDC

There are both tangible and intangible benefits of deploying EDC or CTMS technology.Each company will have to evaluate which benefits best fit its situation and adapt its analysis accordingly.

The return on the investment in a clinical trial or study comes from how quickly the study can be completed and the data prepared for analysis. A good CTMS application will provide fast data collection with a much quicker data preparation time.

Use of a quality CTMS solution will also eliminate data entry errors using real-time range and consistency checking along with automated double data entry and rapid adjudication. This substantially reduces data cleansing time and again, gets the data to the analysis stage more quickly.

A time-tested CTMS solution will provide best practices based on years of trial and study experience. For smaller investigators and many mid-level research organizations, having guided best practices means more confidence in the data.

For CTMS solutions that have kept current with regulations and data standards, users will be able to produce FDA-ready data sets with little or no data clean-up required at close-out. This again decreases the time required to see a return on the initial investment while increasing confidence in the data, thus maximizing the market value of the therapy.

As the push for Healthcare IT implementation across our country’s healthcare system takes hold, system interoperability will become increasingly critical. An established CTMS provider will offer a standards-based solution that will easily interoperate with other clinical and research applications to cut integration cost while providing larger, more meaningful data for analysis.

Few companies of any size can keep up with the changing regulatory requirements and data standards (namely CDISC and HL7). CTMS solutions can provide compliance with these regulations and standards as part of their platform, largely relieving the sponsor of the difficult task of adapting their data structure to changes over the life of one or more studies.

Cost: an effective partnership with a qualified CTMS vendor will decrease the use of paper, decrease required man-hours, decrease the length of the study and substantially cut overall cost.

Classes of Providers

Vendors of CTMS solutions can be divided into four classes:

1. Software firm: The pure software company offering technology for clinical trials and studies but offering little or no services other than implementation and maintenance.Their applications are built to be broad, all-encompassing, customizable platforms to support a wide range of features. Some of these companies employ executives from pharmaceutical companies, but generally, have little or no experience actually coordinating clinical trials and do not offer protocol design, coordination or analysis services.

2. CRO as re-seller: Contract Research Organization (CRO) that offers someone else’s technology through a partnership with a software company; the CRO is a re-seller of the software.

3. CRO with in-house database: The CRO with a data management group that offers technology as part of their services. They have some technology but they do not have a licensable or subscription-based software product or standard software product management procedures.

4. Hybrid CRO/software company: The full-service CRO that has the full capabilities of a software company within itself. These firms will have a licensable or subscription-based product sold as part of their services or without any services and will adhere to all standard software product management and support principles.

Which Provider is Right for You?

Large pharmaceutical companies with ample human and technology resources have their choice of vendors from all four classes, but are most likely to partner with a pure software firm as they rarely require clinical and data support services, generic best practices or application hosting, which are the primary advantages of the other three classes of vendors.

Small- and medium-sized companies and individual investigators in any setting should consider the degree of in-house IT and clinical support they have as well as the time commitment related to using in-house IT to support a CTMS application. Generally, these types of investigators will want to avoid the pure software firm. These firms cannot provide the expert clinical trial and study management to appropriately guide the implementation and provide the services typically required in a data management system. Software companies also rarely understand the rigor and 100% accuracy requirement that is unique to the clinical trial industry; it isn’t built into their culture.

In choosing among the three CRO-based classes of provider, the buyer needs to understand the CRO’s range of services as well as their commitment to developing and supporting the software and their control over the feature set. A CRO that is a reseller of a software company’s product will have little or no control over the direction of the software product. Also, the software company’s commitment to the CRO’s clients is not likely to be equal to the CRO’s commitment to its own clients.

The last two classes of provider are both CROs with their own software. These products are likely developed over years of use on real studies across a wide range of study types and sizes, allowing for the creation of a hardened, feature-rich application with time-tested results. The differentiator between the two classes is their long-term commitment and investment in the software. In the simplest terms, if a CRO has software but does not invest in it and manage it like a software company would, what will the long-term success of the software be? Will there be upgrades? How is the documentation provided and updated? Is there online help? Is there someone experienced in software support available? How and when will new features in the product be released?

What To Consider Before Selecting a CRO and its Technology

Selecting a CTMS vendor should always begin with determining the needs of your organization.This will help in the creation of a list of questions you will use to find the vendors that are right for you. In addition to those listed above, the questions below can be used to differentiate among the classes of vendors.

Did the CRO develop its own technology or is it reselling it for someone else? As previously stated, a CRO reselling a software company’s product will have little or no control over the direction of the product.

Is the technology sold independently of the CRO services? If so, you know the software truly can stand alone and there is an existing software group to support it. If not, the software is not the company’s priority and there isn’t the same level of Q&A, product management, lifecycle planning and long-term investment.

How confident are you in your vendor’s ability to produce results? A CRO with its own technology, compared to a pure software company, will know how to create 100% accurate data sets in FDA-acceptable SDTM format. Also, if the solution is not CDISC compliant, then it is behind the times. FDA submissions should be in SDTM format using ODM xml schema standards. ODM will be replaced with HL7 sometime in the next five to seven years.

Does the vendor have a stand-alone software group separate from the study support group? A dedicated software group shows a commitment/investment in improving and managing the software. Determine what kind of software support the CRO offers. CROs with reliable solutions should have a process in place for collecting and processing customer requests and moving those requests into the product. Make sure the software group offers a service level agreement (SLA) as well as a product roadmap and a release schedule, and ask to see them.

Does the software incorporate time-tested best practices to guide study staff through a proven successful process? Some examples of best practices include FDA SDTM data set formatting, specimen tracking, recruitment tracking, randomization models, visit scheduling, and form design and development.

Has the CRO itself coordinated trials? How many trials/studies have been coordinated from start to finish by the vendor and how many have been done using the software? You want to see diversity in sizes and types, including observational studies, clinical trials, clinical registries, etc. You also want to know that the features that matter to your company have been used on other studies.

Who To Talk To

Once you have identified vendors that you believe meet your needs, meet with the knowledgeable parties to learn more about the vendor and the software. Knowledgeable parties very rarely include the salesperson. Ask to talk to a PI within the company who has used the technology for their own trials. Ask for references of PIs, coordinators and data managers outside of the company who have used the technology.

Make a Long-Term Investment

When evaluating providers, potential buyers should be looking for a long-term partner. As most studies last many months or years, the solution you choose will be an investment you will have to live with on one or more studies for many years to come. A good partner has to provide much more than just good software. Remember, while you will feel rushed to make a decision once you have approval and funding, take enough time to make sure you pick a partner that is right for your company.

Joseph J. Valeri, MBA, MS is vice president and chief information office of Clinical Trials & Surveys Corp. (C-TASC), a clinical trials solutions firm based in Baltimore, MD.