Since the 2008 financial crisis knocked the global macroeconomic environment off of its feet, clinical research organizations
in biopharmaceutical and medical device enterprises faced significant challenges as they entered into a new operational realm.
Investors have scrutinized biopharmaceutical and medical device enterprises to operate more efficiently, strategically, and
cost effectively in the new economy. Moreover, increasing global competition from generics and a glut of expiring patents
have forced many biopharmaceutical and medical device companies to rethink their operational strategies.
Large biopharmaceutical enterprises have divested from existing R&D models, and have paid top dollar to acquire other companies
that offered diversified medical product portfolios in their pipelines. For example, in 2009 Pfizer acquired Wyeth for $68
billion, Merck acquired Schering-Plough for $47 billion, and Roche acquired Genentech for $47 billion. In addition, these
companies pursued acquisitions in an attempt to mold into the new economic model, which requires cost efficiency, scalability
and medical product portfolio diversification on the bottom line, and geographic expansion on the top line. As a result of
changes in strategic directions and acquisitions, the biopharmaceutical industry made job cuts in order to consolidate operations.
From 2008 to 2010, the pharmaceutical industry laid off over 157,000 employees. While the number of laid off R&D personnel
is not confirmed, it is estimated that approximately 8,200 R&D personnel were laid off around that time period (1).
An unfortunate crux of the outcome of the financial crisis is that remaining staff supported lost resources from job cuts,
as labor productivity rose on an annualized rate from 0.6%, 2.9%, and 3.1% from 2008 to 2010, respectively. Others left their
organizations to seek further opportunities; in a recent poll, 43% of clinical operations respondents indicated that they
left their roles because of too many organizational changes, and 29% needed more challenges in their roles (2). Complications
associated with staff turnover involve the loss of intangible value that is affiliated with the process. A research study
discovered that staff turnover, particularly in the services sector, results in the cost of over 150% to 200% of a staff's
annual salary, (3), and 500% of a staff's annual salary for highly skilled professionals, (4). To elaborate, since the nature
of clinical trials is highly dynamic, there is a heavy dependence on human skills, which involves specific areas of study
expertise, strategic decision-making capabilities, GCP knowledge, and clinical trial business process experience, which attribute
toward the cost impact of staff turnover.
While the clinical trial industry relies heavily on human skills, clinical trial technologies and federal regulations have
been changing to address industry challenges. Many cloud-based and IT solutions are emerging; these solutions integrate data
from a variety of sources and offer enhanced insights and data visualization capabilities in one place. Furthermore, FDA's
new guidance on risk-based and centralized monitoring enables clinical trial organizations to practice novel and efficient
monitoring methods. The guidance encourages centralized monitors to undergo statistical training, (5).
With drastic changes in biopharmaceutical and medical device strategic initiatives, reform in federal regulations, and the
introduction of novel IT systems, clinical trial personnel need to be prepared to fit into the new clinical trial model.
In the early-mid 2000s, there was a boom in clinical-IT systems and data collection solutions. While these tools offered management
some insights, they were not as effective and comprehensive as today's IT solutions. Today's clinical-IT solutions not only
integrate data from multiple sources, but offer breakthrough and customizable visualizations, real-time data, and cost efficient
resolutions in order to assist clinical teams with decision-making. Many enterprises are releasing system-based to cloud-based
Some biopharmaceutical companies have gone as far as fully leveraging IT solutions to implement virtual clinical trials. Pfizer,
for instance, conducted the first fully virtual clinical trial "REMOTE" in collaboration with the FDA, where patients were
consented electronically, medical products were sent directly to patients' homes, and patients were to conduct virtual doctor
visits. This breakthrough trial design and platform seemed to have worked except for lagging subject recruitment activities,
which depended on social media, (6). While subject recruitment was deemed unsuccessful by some, Pfizer indicated that they
will use this model in future trials.
Albeit clinical-IT innovation is exciting, clinical trial personnel are not yet equipped with the appropriate skills to analyze
and comprehend IT offerings. In sponsor outsourcing, for instance, data visualization and insight misinterpretation can led
to suboptimal decisions. As interviews with a clinical project manager indicated, their group misunderstood a data visualization,
which identified enrollment under performance at several sites, and the group, subsequently, spent a significant amount of
resources on unnecessary activities. The visualization merely suggested that the site was lagging in subject enrollment, and
proper interpretation would have led to enriched decision-making.