The Problem

As life sciences companies forge ahead with their medical products, they move from early-stage clinical trials to multi-site, high volume trials. This growth causes the myriad of
trial-associated tasks and documents to expand exponentially. Companies soon recognize the need for a central system to aid them in managing this growth. The question is: “How to meet this challenge and stay on track with the organizational goals?”

Vendor-supplied software provides a cost-and time-beneficial alternative to developing ‘tailored’ in-house systems. Over the past ten years, independent software houses have sprung up nearly geometrically, offering a variety of options to potential buyers. In addition to independent software houses, the vendors of database systems and electronic data capture (EDC) are now offering Clinical Trials Management System (CTMS) software alternatives directly or through business partners.

By now, there are nearly a hundred or so options for CTMS software. There is at least one solution that best fits a particular organization's system requirements --but which one? The cost of making the wrong selection can be enormous.

A principal mistake has been for a company to buy a CTMS to manage the current, low-level of clinical trial activity. When the company expands from Phase II to Phase III trials, the organization suddenly discovers that their ‘choice’ was not designed to be ‘scalable’ and cannot respond to the increase in data capture, data management and documentation requirements. The same can be said when some of these companies have found out that the simpler, often ASP-hosted systems they originally deployed, cannot handle a high level of volume.

This inefficiency attracted the attention of Winchester while working with clients. For several years, Winchester has been advising clients on their system requirements and what pitfalls to avoid.

Winchester consultants observed that a great many software selections were often poorly made and ultimately extremely costly.

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