Clinical Trials in Saudi Arabia: An Insight from PDC-CRO

By Danélia Botes

April 3, 2024

Introduction: Advancing Clinical Trials in the Gulf and Levant Regions

In 2023, PDC-CRO, a top clinical research organisation, executed a direct-to-biotech strategy. This strategy bolstered its status as a comprehensive partner for biotech firms in the Gulf and Levant regions. Saudi Arabia, with its growing healthcare sector, benefited significantly from this strategy. The country’s regulatory environment, commercial influence, and large patient population underpin its increasing influence. This article summarises a recent interview with PDC-CRO’s CEO, Mohamed Mostafa, posted on Pharma Boardroom, providing insightful perspectives on the future of clinical trials in Saudi Arabia.

The Direct-to-Biotech Strategy: A Game Changer

PDC-CRO’s success in 2023 can be attributed to a strategic focus on a direct-to-biotech strategy, which differs from traditional approaches that heavily rely on subcontracting with major CROs. This approach involves providing comprehensive support to biotech firms in the Gulf and Levant regions including the UAE, Jordan, and Lebanon. This investment has positioned PDC-CRO well to compete in the market and effectively serve its biotech partners. They have adopted a model where 50% of revenue comes from worldwide CRO collaborations and 50% from biotech direct engagement.

Saudi Arabia: A Key Player in Clinical Trials

Saudi Arabia holds significant importance in the region and the global healthcare industry. The country’s regulatory framework has evolved remarkably. Moreover, ensuring a robust system for clinical trials and research ethics, outperforming Egypt and Algeria. Furthermore, the mandate for Big Pharma to establish regional offices in Saudi Arabia reflects the growing commercial significance of the market. Clinical trials are ideal in Saudi Arabia due to its size and commercial power. Novartis, MSD, and Pfizer have acknowledged this and adjusted their strategies.

Overcoming Challenges in Clinical Trials

Despite the advancements, conducting clinical trials in Saudi Arabia comes with its own set of challenges. These include ensuring efficient trial management, motivating investigators, and logistical coordination. However, the establishment of dedicated clinical trial units within hospitals and the introduction of site management organisations (SMOs) has facilitated trial operations, making participation more attractive to investigators.

The Future of Clinical Trials in Saudi Arabia

Looking ahead, PDC-CRO aims to engage in phase one clinical trials in Saudi Arabia. They are committed to provide full clinical development from the outset. The company also plans to introduce managed access programs in Saudi Arabia through its sister company, aiming to bring products developed by global biotechs to patients in need.

Harnessing Financial Investment and Operational Strategy

While financial investment from major players like Elanco exists, there is often a lack of strategic alignment and operational presence in the region. This disconnect between financial investment and operational strategy highlights a crucial gap that needs to be addressed. To fully capitalise on Saudi Arabia’s potential as a hub for clinical trials, there needs to be alignment between scientific, strategic, and investment objectives. Companies must develop comprehensive strategies that consider the unique opportunities and challenges present in the region.

Conclusion:

In conclusion, PDC-CRO steadfastly commits to discovering effective patient treatments across the region. The company views clinical trials as a viable enhancement to treatment options and works tirelessly to progress the clinical trial landscape. This showcases the country’s potential. Through the alignment of financial investment and operational strategy, PDC-CRO forges a future where Saudi Arabia enjoys more accessible and effective healthcare. 

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