The Whole Product An Integrated Approach to Evaluating & Selecting a Clinical Trial Management System

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Summary

For institutions, deriving real value from investments in clinical research management systems requires long-term vision and carefully honed selection criteria. The evaluation and selection process can be enhanced by utilizing a technique known as the “Whole Product” approach.

The Whole Product approach, in this context, looks at the entire ecosystem that is created by the technology, its adoption within the research institution, and the technology provider. Aspects of this approach encompass: (1) the current product, (2) innovation, (3) release management, (4) training, (5) adoption, (6) integration, and (7) community.

This document outlines the general principles of the Whole Product approach for selecting clinical trial management systems in support of research operations.

The Whole Product

An Integrated Approach to Evaluating & Selecting a Clinical Trial

Management System

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WHOLE PRODUCT

The Whole Product

Even the world’s greatest technology is just a starting point in a much larger ecosystem that is sometimes referred to as the Whole Product. For institutions to derive real value from their technology investments there are many considerations that need to be addressed, each of which call for nontrivial amounts of focus, dedication, and resource commitment from the vendor as well as the institution.

The following provides key questions and a brief discussion of these important considerations, grouped into the major areas shown in the diagram at right.

C

urrent

P

roduCt

Current Product refers to the currently available functionality of the software. The key question here for institutions: Does the existing software functionality provide adequate coverage of your institution’s mission-critical needs, as well as its high-priority requirements for the near future?

I

nnovatIon

Successful software adoption and use is an ongoing process that is never truly complete.

How will the system continue to evolve to keep pace with your institution’s changing needs? How will innovations from you and other members of the user community get included in newer versions of the software? How will changes in regulations or industry standards be incorporated as the software evolves?

r

elease

M

anageMent

Release Management encompasses Release Plans, Requirement Prioritization, Change Management, Quality Assurance, and Software Deployment. Does the software vendor have well-defined plans, management controls, and a track record of good performance?

Additional, relevant questions are:

z Does the software provider have regular release

schedules to address timely resolution of major anomalies, minor anomalies, and new requirements?

z How are new requirements prioritized and assigned to

releases?

z How well are new requirements originating from

changes in regulatory requirements, science, etc., addressed?

z What mechanisms are in place to ensure that new

requirements are addressed while not introducing new problems into the existing functionality?

z What mechanisms are in place to ensure that the

software performs as specified and provides a consistent user experience and dependable performance?

Fig 1. The Forte Research Systems Whole Product Approach

z Are there well-defined processes and mechanisms in

place to ensure that the initial software installation and ongoing upgrades are correctly and completely deployed?

t

raInIng

Does the software provider have proven mechanisms for initial and ongoing training and education, to ensure that users have a solid understanding of the capabilities and intended use of the software?

Additionally:

z Is there a field-tested training plan with adequate

training events for the institution’s administrators and users?

z What training tools (such as documents, exercises, and

multi-media tutorials) are available to software users?

z What mechanisms exist to ensure continuous user

education?

a

doPtIon

Are plans for initial software implementation and subsequent rollout, and mechanisms for ensuring the adoption and active use of the software, in line with your institution’s goals and priorities? The relevant questions are:

z Is there a well-defined and proven implementation

plan and adequate project management tools to ensure a successful initial implementation?

z What is the vendor’s track record in customizing the

implementation plan to meet institution-specific goals, priorities, and operational nuances?

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WHOLE PRODUCT

z What is the vendor’s track record in delivering on-time

and on-budget implementations?

z Does the vendor offer any help, beyond the initial

implementation, with adopting additional functionality or with rolling out the system to additional groups throughout the institution?

z Is it easy to learn what functionality other institutions

have adopted and what their operational experience has been?

I

ntegratIon

In the context of the existing technology investments of the institution, does the software have the required capabilities, and does the provider offer the needed services, to interface with your institution’s existing internal systems? Another very important aspect to understand is the vendor’s willingness to adopt standards and to interface with external entities such as other technology providers, including competitors.

C

oMMunIty

Are you entering into a one-to-one relationship with the software provider, or would you become part of a larger community that has shared concerns? It is also important to understand what mechanisms exist for the user community to interact, the types of interactions available, and the value that is expected to be derived. More specifically, is it just a user group which occasionally meets to discuss software change requests? Or, does the community provide opportunity for discussing operational issues that would help address non-technology related challenges?

Forte Research Systems develops and markets clinical and translational research management software for better compliance, safety, and financial viability. The company’s flagship product, the OnCore® _{Enterprise Research system,}

has been meeting the needs of academic medical centers, CTSAs, research hospitals, and cancer centers for over a decade. For Research Sites, Site Networks, and SMOs, Forte offers Allegro®_CTMS.

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Reprints available upon request.

Forte Research Systems, Inc.

www.ForteResearch.com

info@ForteResearch.com 608.826.6002