Traditionally, many trial sponsors, especially larger pharmaceutical companies, have relied on clinical research organizations (CROs) to tactically execute trial programs per their strategies and solutions. However, with complexities to development such as continuously updated regulations, the volume of technology solutions, and the industry’s collective focus on patient-centered drug development, sponsors recognize that the right combinations of expertise, tools, and resources for successful drug development in the current and future clinical landscape are evolving. 

When sorting through ever-changing and complex development pathways, trial sponsors are regarding CROs more and more as consultative thought partners. Sponsors are leaning on CROs for innovative and agile strategies and seamless integrations of various functional expertise, scalable tech-enabled solutions, and valuations of data insights to best guide their clinical research programs. Going one step further, in navigating through which experts and solutions are appropriate for their individual trials, sponsors see value in closely working with their CRO partners to determine the right components for effective and efficient trials. From trial planning, design, operational execution, and ongoing strategic guidance, sponsors and CROs are working hand-in-hand more than ever to keep important clinical research moving for patients, despite the shifting framework of how research is done. 

Adopting Remote Monitoring 
During the pandemic, some CROs were able to leverage sponsor relationships, therapeutic expertise, and experiences in other business continuity situations such as natural disasters to evaluate and anticipate how damaging the pandemic could be to trial continuity and which mitigation strategies would be effective.
 
Regulatory agencies and investigator sites showed increasing acceptance of remote activities including remote site monitoring. Those CROs with earlier investments in remote capabilities such as central data monitoring were able to quickly work with sponsors to share insights based on experience with multiple sponsors and guide them on recommended solutions and how to scale them per trial profile to ensure data quality and patient safety were always top of mind despite lack of on-site access.  For example, IQVIA research shows that remote monitoring visits as a percent of total visits has stabilized at approximately 20% globally over the last several quarters compared to less than 5% prior to the pandemic.
 
CROs also worked with sponsors to focus on risk-based monitoring (RBM) strategies to better de-risk trials, thereby reducing human errors and data integrity issues and ensuring faster action to correct areas of concern. Sponsors who integrated RBM into trial protocols prior to COVID-19 did not have to go through extra hoops of securing regulatory approval across regions. However, for those who did not design RBM into initial protocols, CRO teams with regulatory experience and relationships were able to execute and oversee the necessary amendments country-by-country quickly.  
 
Experienced CROs who continue to keep a watchful eye on changes in the landscape (e.g., effects of COVID-19 variants) and site and regulatory appetites for continuing with remote monitoring and other similar solutions can aid sponsors in making adjustments to ongoing trials and in the design of future trials.
 
Gauging Decentralized Clinical Trial Interest 
Prior to COVID-19, a limited number of CROs focused on the use of Decentralized Clinical Trial (DCT) solutions to enhance patient engagement and retention and increase trial efficiencies. Using that DCT knowledge base and working with multiple sponsors in various capacities of DCT solutions integration, CRO partners were able to evaluate what DCT elements were of interest among varying stakeholders, especially patients, during the pandemic.    
 
Post-pandemic, sponsors are showing growing interest in DCT elements. Since most trials cannot go 100% virtual, routing through what elements are beneficial and appropriate for each trial program can be difficult without prior experience. Sponsors may turn to CROs with DCT capabilities and these experiences to understand what virtual solutions are available and appropriate for their trials, thereby increasing patient attraction and retention. This is especially important as DCT solutions can range greatly from telehealth; connected devices; 24/7 online patient support; mobile nurse research services for at-home treatments, infusions, and lab procedures; and more. 
 
It is also key for sponsors to keep in mind that integrating innovative virtual technologies into trials to accommodate remote activities is effective when the related expertise is involved as well. Due to the increased direct engagement with the patient, the human factor is critical to optimizing these DCT solutions. For example, as part of IQVIA’s DCT solutions, patients can work with a study concierge for support through coordination of trial logistics, device training, and more. 
 
Collaborative Spotlight on Diversity & Inclusion 
Though industry stakeholders have incorporated diversity in clinical trials when appropriate for decades, the pandemic shined a light on the issue like never before. It heightened focus among industry and society on why addressing barriers to research participation is critical to improve patient outcomes for all. 
 
CROs like IQVIA who are actively committed to working with sponsors, advocacy groups, regulatory authorities, healthcare providers, patients, and more can help lead the way around viable solutions. Based on long-standing work with various pharmaceutical companies and sites across the globe and across numerous therapeutic areas, CROs can bring to the table different experiences to share with leading global advocacy groups/change makers such as PhRMA and the Association of Clinical Research Organizations to help transform the industry mindset on how to improve participation among traditionally underrepresented populations and help ensure clinical research is a care option for everyone.
 
Helping sponsors and others in the industry understand why foregoing competition to work as a collective unit is critical to raising the bar and making a long-standing impact to help ensure trials become more reflective of the diversity inherent in our population. For example, making changes within one site of one trial within one sponsor’s realm can have some impact. But, imagine the dent we could make if multiple sponsors, sites, CROs, and other stakeholders were able to break down information silos across the larger healthcare ecosystem (regionally and globally) to make sure diverse patient populations were aware and engaged in critical research. As COVID-19 vaccine research ramped up last year, the effectiveness of that collaborative approach to better address barriers to participation was apparent. In many cases, sponsors and CRO partners worked closely to drum up innovative strategies to reach the right patients for the right trials by collaboration with digital social media companies, tech solutions companies, and more. And, as possible, some CROs worked with sponsors to better engage diverse investigators to help build trust among patient populations and reach patients where they are. 
 
We know the clinical trial landscape will continue to evolve with additional complexities to consider and address. As sponsors will need to continuously drum up innovative ways to make strategic adjustments or develop agile approaches and at a fast pace to boot, they are looking well beyond tactical trial execution from CROs. Instead, it is increasingly common for sponsors to view CROs as partners, where expertise and patient-centered solutions in trial strategy, design, operations, regulatory compliance, therapeutic spaces, and more are helping to advance critical drug development even during the biggest global health challenge of our lifetimes. We can only expect for the consultative nature of the CRO/sponsor relationship to strengthen as we look ahead to future trials successfully meeting needs of all patients.