Improving Clinical Trial Quality & Productivity at Investigative Sites


Applied Clinical Trials

Due to skyrocketing healthcare costs, and lower profitability associated with healthcare business operations, many industry experts are speaking to the importance of improving productivity in clinical trials.  The biopharmaceutical industry’s initiatives that focus on enhancing productivity and saving costs have raised study site awareness around the same issues.  Study sites are now tackling the hurdle of how they, too, could improve profitability and save costs through clinical trial productivity and efficiency.

In order for study sites to realize this objective in their clinical trial research centers, study sites must first transform the core competencies of their organizations into healthcare business centers that are capable of operating in today’s economy, which includes adopting IT & EHR systems, implementing risk-mitigation strategies, and enforcing business productivity directives.

The Wave of IT Systems in Healthcare:

Due to several initiatives released by the US government that offer subsidies to healthcare enterprises that invest in IT systems [1], many study sites are starting to experience a wave of EHR integration and the implementation electronic health systems in study site business operations.  According to a study conducted by the CDC, 54% of physicians have adopted EHR technologies in 2011 [2].   Moreover, in a recent poll, 57% of respondents indicated that sites need to improve clinical trial productivity because of low profitability, whereas 29% suggested that everyone else is realizing efficiencies, so they need to do it as well [3].

How IT Systems Could Improve Clinical Trial Productivity

IT systems and EHR adoption is important in realizing business productivity.  While there has been some skepticism and frustration around whether EHR improves productivity, if used properly with strategic business expertise, healthcare organizations can realize significant improvements in not only business productivity, but also in patient safety, predicting health outcomes, and reducing re-hospitalizations.

From the clinical trial perspective, such technologies enable study sites to develop audit trails and operational consistency in medical record & source documentation, establish database integration capabilities with EDC systems and Sponsor databases, all of which enhance the ease of data transmission, and actuate efficient and centralized clinical trial monitoring practices.

To study sites this means higher compliance, less monitoring visit preparation & on-site monitoring visit times, organized trial master file implementation, improved patient safety, and the ability to offer risk-based monitoring services to Sponsors & CROs.

What Are Other Sites Doing to Realize Clinical Trial Productivity?

Some clinical trial sites designed internalized business systems to improve productivity and clinical trial quality.  A research study sponsored by DIA outlined a clinical trial business process that was implemented at the New York University School of Medicine network, which includes a vast network of medical centers and individual physician practices [4].

This network hosts an electronic database that integrates clinical trial & site data to identify site risk through statistical analyses and satellite site survey implementation, hence, reducing clinical trial subject risk from clinical trial exposure.  Further, the network employs specialized personnel, who act as liaisons between the sites and the Sponsor/CRO to assist with site training, GCP implementation, monitoring, query resolution, and site closeout visits.

Establishing a strong network of medical practices & medical centers, and executing a robust clinical trial business operational system through database integration capabilities and employing internal clinical operations specialists improves patient reach, enhances clinical trial quality, and ameliorates clinical trial productivity.

While this type of an infrastructure would work best with advanced business procedures and IT system capabilities, medical centers could start optimizing their businesses to support clinical trial productivity and cost savings soon after they have implemented IT systems in their healthcare business operations.

What Can Study Sites Do Now to Prepare for Improvements in Productivity?

In order to prepare for the future and realize improvements in clinical trial efficiency and productivity, it would be optimal for sites to perform the following actions:

1. Consolidate Clinical Operational Business Procedures

Many sites tend to hold regulatory documentation and study materials in individual study binders and files.  In order to realize efficiencies, study sites should establish an internalized trial master file system that combines all study documentation, separated by sections and studies; For example, organizing a single trial master file for participating investigator CVs, 1572s, etc. and source documentation separated by study (and patient IDs if applicable).  Establishing such a structure would facilitate the ease of internalizing monitoring activities explained below.

2. Internalize Monitoring Activities

Oftentimes, study sites spend a significant amount of time preparing for on-site monitoring visits.  If Research Coordinators conduct regular study monitoring of all active clinical trials, study sites could significantly reduce IMV preparation times and the duration of IMVs (especially in combination with suggestion #1).  Moreover, such activities would enable Research Coordinators to develop site monitoring experience.

3. Establish Electronic Procedures in Preparation for Database Integrations

If the study site is implementing electronic IT systems, study sites should think about how they could integrate the aforementioned procedures into those electronic systems, and prepare their databases for database integrations with the Sponsor/CRO databases.  If a study site is able to integrate their IT systems with the CRO/Sponsor, study sites could realize significant improvements in productivity through on-site monitoring visit reduction (even on-site monitoring visit elimination with FDA’s new guidance documents on Risk-Based Monitoring), and real-time data uploads.  Moreover, establishing database integration capabilities would improve the chances that a Sponsor/CRO would re-select the site in future clinical trials.


By Moe Alsumidaie, President & Chief Scientific Officer, Annex Clinical.  Moe can be reached at [email protected] and at


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