Catalyzed by the COVID-19 pandemic, which has created understandable hesitancy among patients to visit hospitals, the sector has reached a pivotal moment where breakthrough patient-centric data collection innovations are more important than ever. 
 
The industry has been talking about patient centricity for a long time and the pandemic has accelerated the adoption of virtual or decentralized trial models, enabling patients to stay at home while participating in trials. While this approach has been welcomed by patients, it has created new challenges for data management teams. These challenges are likely to stay as the decentralized approach delivers a level of convenience that patients will be reluctant to move away from. Collection of data from patients on various fronts must be planned based on the needs of the study protocol, while they stay in their homes.
 
Beyond the traditional data collection and management framework, data management teams now have additional responsibility to bring in efficiencies at all stakeholder levels by understanding and implementing the best technology options for the overall data collection strategy. Interoperability between systems will be a vital development in coming years, as there is not yet a platform which can capture and synthesize data from all data collection streams. 
 
eDiaries/ePROs
Patient reported outcome (PRO) data is collected in correlation with study visit structure, treatment administration schedules or adverse events. The role of a data manager now is to understand the need for an appropriate system which could enable seamless flow of data between ePRO tools and central data repositories. It’s also important to understand the capability for tools to use patients’ own devices (mobile phones, tablets or computers) to access data. Bring your own device (BYOD) models help compliance to data reporting so understanding their use and how to capture and integrate data from these devices will be essential in coming years.
 
Tele-Capabilities
Traditionally, all processes involving patients in clinical trials are done in person starting from recruitment, screening and required study visits. With the world moving towards a digital approach thanks to advancement in telecommunications, clinical trials are benefiting from the greater convenience afforded by mobile devices and computer. Patients can go through recruitment, consenting, screening and visits over platforms that support virtual access to patients for sites and investigators. While all these interactions generate data, understanding the capabilities is essential to appropriating data flow to electronic data capture (EDC) or electronic health records (EHRs) and enhancing real-time data collection. 
 
The environment is providing immense opportunity to implement the real-time data-driven risk-based monitoring plans. The technology that enables sponsors to facilitate seamless data flow between integrated data collection systems which give access to real-time data is key for an effective risk-based monitoring plan implementation.
 
The use of technologies with e-recruitment, e-screening, tele/e-consenting, tele visit capabilities and electronic clinical outcome assessment (eCOA) enables researchers to collect relevant data which can now be integrated with EDCs. Interoperability expectations between systems from a regulatory standpoint also (eg: 21 Century cure’s Act in the US) encourages integrations between EMR/EHRs or lab databases which could allow comprehensive real-time access to trial information.