COVID-19, Work life and the Workplace: A chat with Pharma Clinical Line Manager - Limor Rozner

?Pharma Clinical team member Limor Rozner has over 13 years of extensive experience in clinical trials as CRA, Country Lead Monitor as well as other leading roles. She is now acting as a Line Manager, focusing more on the professional progress of our team members.

We asked Limor what challenges our team has faced during the COVID-19 pandemic, and what opportunities she feels have arisen as a result of our transforming work environment.

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How has COVID-19 impacted the field of clinical trials?

The outbreak of the COVID-19 pandemic in 2020 and the several lockdowns that were instituted in Israel as a response had the potential to greatly challenge the field of clinical trials in Israel. Submission and review of new applications, patient recruitment, ongoing patient visits and monitoring activities – all of these had to be adapted to the new circumstances. To resolve this, the Ministry of Health quickly published special guidelines, allowing fully digitized submission of clinical trial applications with no hard copies needed; provision of study medication directly from the site pharmacy to the patients’ homes; the option for a patient to undergo study procedures and treatment at another medical facility if needed; remote monitoring of patients’ vital signs; as well as an electronic and remote consent process. In short, as many hindrances as possible were eliminated. This proved very effective, and the guidelines have even been extended at least until the end of 2022.

?What do you see as long-term changes that COVID has brought to clinical trials?

COVID has definitely proven that bureaucratic processes can move faster and more efficiently when the need arises. Digitization, both of submissions and trial data, has taken a big step forward and we expect this trend to continue, including an increase in decentralized trials in Israel. Risk-based monitoring, an approach adopted even before the pandemic, has been very effective in reducing the number of on-site visits and will probably evolve further. Remote source data verification is not yet possible in Israel since electronic medical records cannot be accessed externally, but hopefully this too will change in the upcoming years.

?How did Pharma Clinical pivot in response to dealing with the pandemic?

As a CRO specializing in clinical operations for clinical trials, the outbreak of the COVID pandemic challenged us with limited access to the office and to the medical centers in which our studies are conducted. Since our company already had an established VPN connection option in place, we were quickly able to almost seamlessly pivot to a working model in which a limited number of employees worked from the office based on study tasks that required office presence, and the rest of the team worked from home. This model relies heavily on employees’ commitment and work ethics, and our incredible team really stepped up to the task! Despite the challenges of working from home during the pandemic, our team still managed to meet all targets and deadlines during those difficult months.

The limited access to the medical centers was managed through increased use of remote communication methods. Site selection and initiation visits were conducted over Zoom; some monitoring activities were conducted remotely, with the cooperation of the site staff that provided redacted copies of the source data; and whenever allowed by the study protocols, remote patient management and supply of study medication were instituted.

What new opportunities opened to Pharma Clinical during the COVID period?

During the COVID period, we discovered that is possible to work differently. While working from home certainly comes with complications, we have found that at times it can even be more efficient than work at the office. At the same time, it was clear that the office is more suitable for certain tasks and that office interactions can be very valuable as well. Therefore, after the limiting regulations were lifted, Pharma Clinical decided to continue operating on a hybrid model that officially combines office days and home days for all role functions at the company.

As this change in perspective toward remote modes of communication is shared by the entire clinical trials industry, we have found that new business opportunities have opened up for us. The new norm of virtual meetings has made scheduling meetings more efficient, enabling us to reach a much greater pool of clients. ?With traveling restrictions across the world coming and going, the importance of being a strong local business has also increased. Business models like that of ACROSS Global, which connects between highly qualified local organizations to create a strong global work force, have become doubly effective in the COVID period.

If we were to sum up our experience in the past two years, it would be safe to say that the COVID pandemic has inspired us as an organization to be flexible, resourceful and efficient, also reinforcing our commitment to the company and to each other. We are proud of our team and their success!