Foreword
Clinical Trial Management Systems—Moving with the Times Sian Bithell
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o ensure that clinical trials achieve their primary purpose of collecting data effectively, stakeholders have always looked for solutions that facilitate the management of data, trial logistics, and project flow. The way that clinical trials are conducted is being transformed to a remarkable degree. Of the many challenges facing the pharma industry today, the need for greater operational efficiency in clinical drug development is of paramount importance. With flat and even declining productivity, rising R&D costs, more-complex pre-approval trials, and large post-approval studies driven by increasing regulatory demands, it is essential that clinical trials are managed more effectively and efficiently.
The increasingly global nature of clinical trials has also created unique challenges and complex logistic needs. Technology solutions, such as electronic data capture (EDC), clinical data management systems (CDMS), and randomization and trial supply management systems such as interactive voice response systems (IVRS) and interactive web response systems (IWRS) have been used to enhance the conduct of clinical trials. However, a clinical trial management system (CTMS) is the central hub that manages the functions and drives the convergence of the many systems that form the clinical trial ecosystem. A CTMS can empower organizations to enhance productivity and effectiveness of clinical development by expediting and better managing clinical trials. With a look to the future, and across the globe, as the eClinical environment continues to evolve and mature, organizations will need to keep in mind a number of significant considerations, regardless of whether it is an upgrade path or de novo implementation.
In our report, The Power of CTMS—Integration, Interoperability, and Collaboration, we have commissioned a series of articles that provide expert opinion, analysis, and insight into the firm belief that CTMS will support clinical trials well into the future.
The first article, ‘Clinical Trial Management Systems—A Decision-supporting Engine for the Future’, written by Chris Huang, Oracle Health Sciences, examines the potential of CTMS as it evolves from a perceived logistics system to a powerful decision-support engine. Here, Chris Huang also provides foresights into how the evolving solutions will add future value to investments.
From Accenture, Henry Levy’s review, ‘The Clinical Trial Management System—The Central Intelligence Hub’, reflects on the benefits of CTMS as an end-to-end turn-key solution and its potential as the central hub in an integrated clinical system that serves the needs of all stake holders in the process; from the sponsor right down to the patients themselves.
Following on from this, ‘Clinical Trial Management Systems in the World of Mergers and Acquisitions—Managing Operational Challenges’ by Christopher Heider, Merck, highlights critical decision points within the M&A process, as well as discussing the challenges faced.
The final article in the series, ‘Flexibility, Interoperability, and Organic Growth—The Challenges of Clinical Trial Management in Emerging Geographies’ written by Lynda Shelley, Novotech, views the decision processes for making the right investment in CTMS from a CRO perspective operating in an emerging territory.
We would like to thank all of our authors for their contributions and trust that you, our readers, will find our report informative and engaging. n
© TOUCH BRIEFINGS 2011
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