Despite the ongoing war and political instability, the clinical research infrastructure in Israel has demonstrated remarkable resilience and operational stability over the past year. Through robust contingency planning, strong on-site teams, and effective risk mitigation strategies, clinical trial operations have continued seamlessly, ensuring that timelines are met and patient engagement remains strong. The ability of clinical sites to remain fully operational, coupled with efficiency of regulatory approvals and commitment of patients and medical staff, has been a testament to Israel's unwavering strength in the field of clinical research.
Several case studies from our work with partner companies demonstrate the resilience of clinical trials in Israel. For instance, in one of the projects we managed, Pharma Clinical played a key role in keeping a trial running smoothly with minimal disruption, despite the ongoing political situation. As our partner highlighted, "Working with Pharma Clinical has been a key factor that allowed us to enroll many more patients than we had anticipated in Israel, thereby enabling us to meet our worldwide enrollment goals on time. Furthermore, the quality of study oversight and data integrity in Israel has been excellent." This example showcases how, even under challenging circumstances, our ability to provide operational stability allowed the trial to progress without delays, benefiting patients and the global research community.
Another example comes from a phase 2 trial in dermato-oncology. One of our collaborators emphasized, "We have not felt any disruptions or changes to our plans since then. On the contrary, jointly, we managed to set the study up in an industry-beating time including smooth and straightforward regulatory approval of the clinical trial... We initiated the first site at the end of May and the first patient was recruited the very next day. We have currently 4 active and engaged sites and very busy enrolment with patients showing first signs of clinical efficacy." This case study underscores the agility and operational expertise Pharma Clinical brings to trial management, even in times of crisis.
Our ability to adapt and maintain operational efficiency has also been demonstrated in several high-pressure scenarios. In October 2023, we successfully completed five remote feasibility assessments, five site selection visits (SSVs), and three site initiation visits (SIVs), despite ongoing rocket fire. During the most critical periods, we facilitated virtual meetings between clinical research associates (CRAs) and site coordinators (SCs) to ensure essential processes like source document verification (SDV) were completed on time. Even in southern regions near the Gaza border, active feasibility assessments were carried out, with sites selected based on promising results. In adherence to Ministry of Health (MOH) guidelines developed during the COVID-19 pandemic, we conducted remote SDR/SDV, ensuring that trials proceeded without delay.
At Pharma Clinical, we take great pride in being a key driver of this operational stability. Our strategic partnerships, proactive management, and close collaborations with local investigators have enabled us to maintain momentum in trials despite the ongoing challenges. We have successfully overseen trial enrollments, ensured smooth regulatory processes, and employed decentralized trial methods when necessary. Our focus on maintaining strong communication with all stakeholders has been pivotal in ensuring that clinical trials in Israel continue to thrive.
In a year marked by uncertainty, the stability of clinical research in Israel, supported by strong CROs like Pharma Clinical, highlights the country's resilience and adaptability. As Israel continues to navigate these challenging times, its robust clinical research infrastructure and unwavering commitment to innovation are ensuring that life-saving research continues to progress, benefiting patients locally and globally.
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