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The rising complexity of clinical trials, combined with pressures resulting from the COVID-19 pandemic, have forced sites, sponsors, and clinical research organizations (CROs) to adopt remote and risk-based approaches for clinical trial execution to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity. With the increasing prevalence of decentralized clinical trials (DCTs), the industry is now poised to fully embrace and implement risk-based quality management approaches to trial execution and oversight.

In 2020, after the COVID-19 pandemic surfaced, the need for alternative approaches to clinical trial execution and data capture became a reality overnight. The concept of implementing components of decentralization within a clinical trial became one of ‘here and now,’ versus a concept of the future. In many instances, the pandemic halted the patient’s ability to go to a site. Recruitment, enrollment and retention rates were challenged; and a large percentage of clinical trials were delayed, and some terminated.

IT- och säkerhetsteamen på alla företag har länge prioriterat att skydda och förhindra förlust av känslig information. Men nu när folk, enheter och appar tar sig långt utanför det traditionella kontorets gränser omprövar informationschefen och informationssäkerhetschefen synen på informationsskydd och de verktyg de behöver för att säkra och förhindra missbruk av känsliga data.