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Pharmaceutical research and development contributes significantly to today’s rising health care costs. Clinical research, a critical component of pharma R&D, ensures a quicker and better return on investment. It also helps organizations deliver better and safer care for patients. Under mounting compliance and economic pressures, organizations can’t do “the same old, same old” and expect success.

The ultimate goal is to develop faster and cheaper treatments. Three promising trends in clinical research present big opportunities for the industry at large:

  1. Risk-based monitoring
  2. The “Big Data” revolution
  3. Applications that improve organizational performance

These trends lead to reduced costs, lower risk and a faster time-to-market.

1. Risk-Based Monitoring

Clinical studies have inherent risks like impacting subject health, maintaining data integrity and more. Organizations must clearly identify these risks in order to properly mitigate them. There are no efficient ways to completely eliminate or avoid the risks. The well known old school techniques like lengthy and resource-consuming 100% source data verification, comprehensive continuous data checks and cleaning, QC on every step from data gathering to data processing, analysis and submission of NDA cannot eliminate the risk.

With the concept of risk-based monitoring, organizations can avoid having to devote excessive resources to verify 100% of captured data. They can reduce overall expenses for clinical monitoring of sites, data checks, data management groups, and more. Organizations can shift necessary resources to the biggest identified risks and devote fewer to low-impact areas. The study sponsor or CRO can assign a risk score and power to each parameter’s coefficient (low, moderate and high). Based on the potential impact, organizations can set up more comprehensive monitoring of pre-identified risk areas ranged from high to low.

The outcome of risk-based monitoring principle ensures a more efficient and cost-effective clinical trial. This savvy use of resources decreases risks, reduces wasted data and at the same time increases patient safety and robustness of the data.

2. The “Big Data” Revolution

Pharma organizations often conduct their own studies, typically housing the data internally.  As a result, the organization works with the same providers, sites and relationships. They continue to build upon them – often to the organization’s detriment.

Big data has the potential to change the behavior of organizations, giving them access to an open source of data. By accessing data from other organizations via open sources, it’s possible to access a wider stream of information such as information about the studies conducted across the U.S and worldwide, identify and select potential clinical trial sites and  investigators per therapeutic area, indication, geography based on their performance in similar studies in the past, and so forth.

There is an increasing number of ongoing studies of patient behavior patterns and compliance with the received therapy where patients continuously report/record their health parameters and health related activities online when receiving conventional treatments via applications on mobile devices. These studies among the other potential benefits will bring us closer to the era of personalized, patient-centric, holistic approach to medicine.

Ultimately, with open-source (or purchased) data, organizations can secure distinct benefits. Enrolling patients faster and shortening trial timelines are just a few. With an extensive information database, organizations can also optimize their site networks. They can also find investigators and optimize resources (such as vendors, sites and investigators). These factors will better serve their study’s goals and drive better business decisions

3. Applications That Improve Organizational Performance

Technology companies are developing applications that serve pharma organizations’ clinical study needs. Mobile applications offer critical features that drive compliance for both investigators and patients.

With social networking tools like calendars and alarms, patients become more invested in the process. They know when to attend scheduled visits and promote on-time medications or procedures. Applications give investigators a real-time overview of patient visits at all sites, enhancing quality and compliance. They can plan their workday based on associated activities with different protocols. And they can enjoy the engaging social networking features of the apps.

These applications affect a study’s outcomes, driving patient and investigator engagement throughout the trial. The study is ultimately more effective, improving quality, compliance and enrollment.


The future looks bright for clinical research organizations faced with compliance and cost pressures. Risk-based monitoring, big data and applications hold many benefits. Most importantly, organizations can reduce clinical study costs and risks and develop treatments faster than ever.

Where Confidence Pharmaceutical Research Fits In

With its decades of experience and a highly integrated team of clinical research associates and vendors, Confidence Pharmaceutical Research saves costs and reduces complexity in clinical trials without jeopardizing results. From a realistic evaluation of budget and schedule to the development of an exit plan when the trial is complete, Confidence is your partner in global clinical research. To find out more, contact us today.