USA: +1 617 939 9497 | UK: +44 2039 962936 | EU: +34 607 939 266 info@sofpromed.com
Select Page

Niche CROs: Accelerating Early Phase Cancer Clinical Trials in the USA

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

16 September, 2023

Niche CROs Accelerating Early Phase Cancer Clinical Trials in the USA

If you are looking for a niche CRO to run an early phase cancer trial in the USA, please contact us at info@sofpromed.com

Clinical trials are essential in the development of new oncology treatments, and their success relies heavily on the expertise and support of clinical research organizations (CROs).

In recent years, small CROs have emerged as key players in accelerating early phase cancer clinical trials in the United States.

In this article you will learn about:

These CROs specialize in oncology trials and offer unique advantages to biotech and pharmaceutical companies.

This article explores the growing importance of small niche CROs in oncology trials and highlights the role they play in phase 1 studies conducted in the United States.

We will also introduce Sofpromed, a highly regarded US-based niche CRO with a global reach and extensive experience in cancer research.

The Growing Importance of Small Niche CROs in Oncology Trials

The field of oncology has witnessed remarkable growth in clinical trial activity, making it one of the most highly-tested therapeutic areas.

With an estimated U.S. market value of $100 billion by 2022, cancer drugs are at the forefront of clinical research [1].

As a result, the demand for specialized CROs that focus on oncology trials has surged.

Niche CROs provide unique advantages compared to larger, more general CROs.

These advantages include a deep knowledge of the disease, established connections with oncology key opinion leaders (KOLs), and a network of cancer clinical sites at the international level.

The Role of Small Niche CROs in Phase 1 Cancer Clinical Trials

Phase 1 oncology trials present unique challenges, particularly in the close monitoring of dose escalation, safety data reviews, and management of biological samples for pharmacokinetics (PK) studies.

Small biotech companies planning their initial phase 1 cancer trials can benefit greatly from partnering with a qualified oncology-focused CRO.

These CROs have the expertise to ensure smooth operations and the generation of robust, high-quality data.

By closely monitoring patients for dose-limiting toxicities (DLTs) and providing experienced clinical operations staff, small niche CROs facilitate the successful execution of phase 1 trials.

Sofpromed: A Niche CRO for Oncology Clinical Trials

Sofpromed is a small CRO that specializes in oncology clinical trials.

With a long-standing experience in managing cancer trials worldwide, Sofpromed offers comprehensive clinical trial management capabilities in North America, Europe, and Asia-Pacific.

Their team comprises clinical operations, data management, and statistical programming experts with extensive experience in oncology, including rare cancers.

Sofpromed’s commitment to meeting the specific needs of small biotech companies makes them an ideal partner for early phase cancer clinical trials in the US.

Clinical Trial Management Capabilities of Sofpromed in the US

Sofpromed provides a wide range of cancer-focused CRO services to conduct phase 1 clinical trials in the United States.

As a full-service CRO, Sofpromed takes care of all tasks and responsibilities involved in the execution of a clinical study, allowing sponsors to focus on their core business activities.

Our service portfolio includes cancer center selection and activation, clinical site management, onsite monitoring, drug safety monitoring, clinical data management, SAS statistical programming, biological sample management, drug logistics, and medical writing.

By offering comprehensive support, Sofpromed ensures the successful implementation of phase 1 oncology trials.

Global Reach and Expertise in Oncology

Despite being a small CRO, Sofpromed’s global reach is a significant advantage for sponsors planning future later-stage oncology clinical trials in multiple countries.

Our extensive network of expert cancer centers and clinical research personnel allows us to quickly identify the best sites for specific studies.

With established connections to renowned oncology sites in the US, such as the University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center, Sofpromed ensures accelerated patient recruitment in the United States.

Our experienced clinical operations staff, including clinical research associates and project managers, are well-positioned to handle the complexities of oncology clinical trials not only in the US, but across multiple continents.

How Small CROs Ensure Fast Recruitment and High-Quality Data

Niche oncology-focused CROs, like Sofpromed, have the advantage of previous experiences with clinical sites that specialize in recruiting cancer patients for early phase studies.

They have established relationships with key opinion leaders in various oncology subspecialties, providing valuable insights and enhancing the quality of clinical protocols.

Additionally, their expertise in data management ensures accurate and reliable collection of safety data, crucial for evaluating treatment-emergent adverse events (TEAEs).

By focusing on oncology trials and leveraging their networks, small niche CROs ensure fast recruitment and high-quality data, accelerating the development of oncology treatments.

Conclusion

In the rapidly evolving field of oncology clinical trials, niche CROs have emerged as valuable partners for biotech and pharmaceutical companies.

Their deep knowledge of the disease, established connections with oncology key opinion leaders, and networks of cancer clinical sites provide strategic advantages and practical benefits.

Sofpromed, a leading small US-based niche CRO, offers comprehensive clinical trial management capabilities and a global reach in oncology.

By partnering with small CROs like Sofpromed, sponsors can accelerate early phase cancer clinical trials in the US, ensure fast recruitment, and generate high-quality data, at an affordable cost.

If you are looking for a niche CRO to run an early phase cancer trial in the USA, please contact us at info@sofpromed.com

References:

[1] Review of Current Policy Strategies to Reduce US Cancer Drug Costs

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

You may also be interested…

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com