Timeline

September 1, 2010
Jeffrey P. Trotter

,
Bill Byrom, PhD

Applied Clinical Trials Supplements

Volume 0, Issue 0

A list of the most influential events affecting the clinical trials industry over the last 30 years.

Medical imaging is employed in all phases of new drug development. Imaging can guide the diagnosis, treatment, and management of disease and serve as biomarkers for prognosis, progression, and outcomes. Whereas traditional imaging methods are largely directed at obtaining anatomical information, functional (i.e., molecular or mechanistic) imaging quantifies real-time physiologic and metabolic processes at the cellular or molecular level. These novel imaging techniques have become attractive biomarkers in clinical trials. Through early determination of drug efficacy, functional imaging techniques promote efficient decision-making in clinical trials, saving time and money.

Mehdi Adineh Scientific Director of the Imaging Core Laboratory ACR Image Metrix Phliadelphia, PA

—Sponsored by ACR Image Metrix

In today's pharmaceutical development world, a great deal of emphasis is placed on developing better drugs as quickly as possible and in the most economical way possible. Adaptive trials now allow sponsors to make dynamic assessments and changes to their studies to minimize costs and development time. However, this dynamic environment creates new challenges for supply chain support vendors and their ability to react to changing procurement, manufacturing, and logistics requirements. Supply chain/procurement vendors today must be agile and nimble with scalable services, flexible manufacturing schedules, and robust procedures that can quickly react to the needs of this evolving marketplace.

John Buchholz Amimed Associate Director, Clinical Trials Winchester, KY

—Sponsored by Amimed

Pharmaceutical companies are facing pressures not only to bring new medicines to market, but to demonstrate long-term safety and real-world value (i.e., clinical performance, cost-effectiveness, and improved quality of life). There is increasing recognition that the conditions under which products are examined for approval are not the conditions under which they may actually be used. Navigating the post-approval landscape requires a roadmap that looks different from the Phase III paradigm. When CROs are viewed as true partners, we can provide the leadership and vision to help our clients achieve success through effective planning, design, and execution of Phase IV research initiatives.

Jeffrey Trotter Executive Vice President, Phase IV Development PharmaNet Princeton, NJ

—Sponsored by PharmaNet

Recently, the industry has seen enormous increases in the number of technology solutions available to help conduct clinical trials. With this has come increased expectations of the way technologies will improve processes, study management, and conduct. Companies now face the problem that management and clinical data are contained within multiple internal and external systems.

Bill Byrom Senior Director, Product Strategy Perceptive Informatics Waltham, MA

Today, the industry can realize the benefit of improved data integration and a fully-integrated eClinical platform using product convergence models, offering the ability to see the "big picture" of a compound's characteristics as it moves through clinical development. Furthermore, we can expect to see an increase in simplified end-user workflow, making functionality that resides in one product available through another.

—Sponsored by Perceptive Informatics

Historically, IVRS solution providers modeled solutions around "vendor standards," requiring clients to adapt their business processes to conform to pre-formed models. While this approach may save a supplier time and effort, it is an unrealistic expectation of a client whose project is uniquely complex. Today, most clinical studies are unable to successfully mold their needs into such a generic "box." Success in the IVRS-Clinical Trials space requires a keen understanding of client's study-specific needs. IVRS solution customization is inevitable in today's complex world of clinical trials. Now, with study-specific tailored solutions, achieving accelerated implementations of highly-complex studies with improved quality and reduced cost is the new reality.

Robert MacDougall Vice President Cenduit LLC Durham, NC

—Sponsored by Cenduit

For the interactive version of the timeline, visit http://appliedclinicaltrialsonline.findpharma.com/retro. Also, for more industry resources, go to appliedclinicaltrialsonline.com. The events chosen for the timeline were made by industry experts, the EAB, and the editors.