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Sofpromed: Regulating Essential Clinical Trials and Observational Studies

Patricio Ledesma of Sofpromed
Patricio Ledesma of Sofpromed

The recent pandemic made the whole world realize the significance of clinical research. The CRO industry was one of the sectors that was in focus during the COVID-19 pandemic to conduct vigorous clinical trials for producing an effective vaccine to combat the coronavirus.

In doing so, CROs had to consider the various processes that went into developing an efficient vaccine, which would help battle the lethal virus.

Sofpromed is one of the leading CROs that specializes in the global management of phase I-IV clinical trials worldwide for biotechnology and pharmaceutical companies.

In the following interview, Patricio Ledesma, the General Manager elaborates on how the company is making an effective contribution in the healthcare space, the challenges that the company came across, and his vision for the company’s future.

Please brief our audience about Sofpromed, its mission, and the key aspects of its stronghold within the contract research niche.

We are a full-service clinical research organization (CRO) specialized in managing phase I-IV clinical trials in oncology for biotechnology and pharmaceutical companies worldwide. The company was founded in 2012 and offers a one-stop approach including regulatory, clinical operations, data management, and statistical programming capabilities to manage cancer trials from beginning to end.

Tell us more about the offerings which make Sofpromed stand out from the competition?

Our key differentiator is a long-standing expertise in managing oncology clinical trials including less frequent tumors such as sarcomas, and rare gynecological and pediatric malignancies, among others. Through our deep knowledge of the rare tumor space and our already established network of high-volume cancer centers across Europe and the United States, we are able to offer effective clinical site selection and fast patient recruitment for sponsors developing anticancer therapies, in both early phase and late-stage studies.

What is your opinion on the impact of the current pandemic on the global CRO vertical, and what challenges did Sofpromed face during the initial phase of the pandemic?

The appearance of the pandemic had a favourable business impact on those CROs that were awarded to manage COVID-19 clinical trials. During the high peaks of the pandemic, the number of coronavirus clinical studies initiated around the world increased massively, substantially augmenting the workload of CROs managing these types of studies.

On the other hand, the abrupt rise of COVID-19 studies at clinical sites affected the staff and technical resources dedicated to clinical trials in other therapeutic areas. During the initial phase of the pandemic, Sofpromed, as a CRO specialized in oncology, observed how cancer patient recruitment slowed down across all studies, and how patient management quality was diminished due to lack of internal resources at sites, restricted access, and less hospital visits.

With continuous development in technologies such as AI and big data, what is your prediction about the future of the CRO vertical?

The application of new technologies, such as AI and big data, to clinical trials are already key value and leadership drivers in the CRO market. Being a technology driven CRO is not an option anymore. Data-based clinical trial simulation can be useful to improve inclusion criteria.

Leading CROs are already adopting AI tools in their workflows. Data analytics provides tremendously valuable information that can improve site selection, recruitment rates, and eventually patient outcomes. Therefore, CROs will need to step into these tools to take their offerings to the next level.

As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the contract research niche?

The clinical trial management sector is an exciting world full of opportunity. Although the CRO industry is led by big multinational players, there is and there will always be abundant market opportunity for small-sized, emerging CROs, which are able to offer value to clinical trial sponsors in general, and to small biotech in particular.

As in other businesses, technical capacity and customer care are essential, but especially in the CRO space, operational flexibility and responsiveness towards the client makes a world of difference. My main advice for an entrepreneur aspiring to venture into a CRO business would be ensuring a good service and really care for the needs and problems of your clients.

How do you envision on scaling Sofpromed’s operations and offerings in 2021?

After 10 years of its foundation, Sofpromed has experienced quick growth in recent months, as the company is rapidly expanding its biotech customer base dedicated to executing international phase II and III clinical trials across Europe and the U.S. The company has an exciting perspective to continue with its organic growth through an increased presence in the U.S. market and the provision of state-of-the-art clinical data management and statistical programming services.

About the Leader

Patricio Ledesma, Sofpromed’s Founder and General Manager, accumulates more than 15 years of experience in the cancer clinical research sector, with wide expertise in leading clinical operation teams in both academic and commercial clinical trials.

Through the years, he has established strategic collaborations with academic cancer research groups and international key opinion leaders, facilitating the effective implementation of multinational clinical studies. He is devoted to helping biotech companies in the planning and execution of phase I-IV clinical trials across North America, Europe, and Asia-Pacific.




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