Xavier Flinois, President, PAREXEL Informatics
Qualified Clinical Research Organizations (CROs) are now making technology decisions when it comes to the development and execution of clinical trials, and rightfully so. They are the most qualified to make decisions for how those trials should be conducted given their knowledge of—and access to—new technologies and their unique clinical domain expertise. In effect, CROs have become Clinical Research and Technology Organizations.
It’s already a cliché that the driving forces of Social media, Mobile, Analytics, and the Cloud (SMAC)—and associated emerging apps—are transforming every company into a software company and every industry into a software industry. The pharmaceutical sector is no exception. In the area of clinical trials, however, this trend is combining with another trend, the expanding role of the CRO. Those CROs that are applying innovative new technologies to the clinical trial process are beginning to stand out in their efforts to simplify the complex drug development journey.
Conducting clinical trials can be a long, costly and complicated process. Therefore, more and more pharmaceutical companies are looking at CROs to increase efficiencies, drive greater flexibility, extend expertise, reduce costs, and leverage limited resources. Ideally, CROs maintain the global expertise and tools that might help pharmaceutical companies facilitate the journey from discovery to new treatments.
Traditionally, CROs would bring their broad and diverse expertise and project capabilities to the sponsor relationship, while another party, a technology vendor, would bring the informatics technology needed to coordinate and track all complex variables and massive amounts of data that go into a clinical trial.
As a direct result of SMAC technologies and other advances, it has become much easier for CROs, especially for forward-thinking CROs with a history in technology, to leverage IT.
A good example of how qualified CROs are also becoming technology advisers and providers is in patient recruitment for clinical trials. Recruitment is a vital element in a clinical trial with the expertise and capabilities residing predominately—and often exclusively—with the CRO. Without the right type and right number of participants, a clinical trial cannot be conducted. Furthermore, costs can escalate if those participants are not identified quickly. Every day loss in trial is an added cost for the sponsor.
With the end of the blockbuster era, when drugs could be developed that were relevant to the health conditions of tens of millions of people, pharmaceutical company strategies are increasingly focused on developing drugs that target specific populations. T his r equires d rug d evelopers t o i dentify a nd recruit very specific patient populations. Therefore, new methods must be devised and implemented for conducting best-in-class recruiting for specific patient and volunteer groups.
Technology-savvy CROs have started using social media and analytics to create those new best-in-class recruitment programs. With tools that blend technological and clinical expertise, CROs can better target, track, and recruit a wide range of volunteer types to a degree that has never been possible before.
"CROs that are applying innovative new technologies to the clinical trial process stand out in their efforts to simplify the complex drug development journey"
Risk-based monitoring is another process that has been made possible through the intersection of technology and clinical expertise. Throughout the trial, all data collected is put in a dossier to test the efficacy of bringing the drug to market. However, all data isn’t equal, and verifying all the data from all the patients at every trial site as if it were equal can increase cost and delay timelines. Risk-based monitoring leverages analytics software that enables CROs with the appropriate capabilities to create a data hierarchy of sites and patients, focusing on those with more tangible and relevant data points and yielding accurate results more efficiently.
As drug development plans increasingly become more global, it is important for CROs to provide a global expertise, the means to simplify processes, and an understanding of how things fit in the bigger journey for the sponsor. A big part of that journey involves technology. Some forward-thinking CROs a more strategic partnership between the sponsor and the CRO. Those CROs that have a universal view of the clinical trial process as well as direct access to technological tools to implement solutions will be best equipped to simplify the journey between science and new treatments. Helping the sponsor design and complete successful clinical trials and ultimately, bring more effective drugs to the market for patients who need them.