Building a Web-based knowledge Repository to Reduce Cost and Improve Efficiency of Clinical Trials

Client
Client is a global pharmaceutical-industry player with branded prescription drugs for such therapeutic areas as oncology, cardiology, diabetes, and respiratory/allergy, as well as human vaccines. The core strategy of the client is to create value by rapidly developing, launching, and marketing innovative drugs that satisfy unmet medical needs in large patient populations.

Challenge
The client’s strategic imperative is product leadership. With the growing number of drugs in the pipeline, managing the increasing quantity and complexity of clinical trials has become a huge challenge. The client currently conducts nearly 50 large, late-stage clinical trials a year around the globe. For our client, as with the pharmaceutical industry, the number of trials is proliferating rapidly without a corresponding increase in the number of clinical investigators and patient subjects. Clinical trials are not only a crucial step in the drug-development process, they are also a major expense. 

Solution
Makro worked with the client’s business users and thought leaders to refine the problem and conceive a solution based on an internal Web-based knowledge repository and portal that could be easily maintained and updated by the users themselves. The resulting intranet application was designed to eliminate the many uncoordinated, ad-hoc, and paper-intensive current processes and to enhance collaboration and information sharing among different divisional teams. The initiative promised to improve recruitment efficiencies, reduce costs, and speed time to market.

Makro then led the design and rapid development of an application that included: an online process guide; an interactive vendor data-collection-and-rating system; an exhaustive repository of tools, recruitment policies, SOPs (standard operating procedures), country reports, and affiliate capability survey reports; and gateways to other internal and external systems and databases.

One of the most challenging requirements was to be agile and flexible enough to support iterative evolutions of underlying processes, many of which are still in their infancy. This goal was achieved by building a powerful mini-content-management application that allows business users to make changes to the site with ease.

The development of the system took into consideration the requirements imposed by 21 CFR Part 11 regulations and complied with exacting FDA documentation and process requirements.