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Phase 1 Clinical Trial Units: Advancing Medical Research Safely

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

25 August, 2023

Phase 1 Clinical Trial Units Advancing Medical Research Safely

In this article you will learn about:

These units provide a controlled environment where the safety and efficacy of experimental drugs are tested for the first time in human subjects.

In this article, we will explore the importance of phase 1 clinical trial units in advancing medical research and discuss their amenities, equipment, and participant population.

We will also highlight the services offered by Sofpromed, a leading CRO in this field.

Let’s dive deeper into the world of phase 1 clinical trial units and understand their significance in the advancement of healthcare.

Amenities and Facilities

Phase 1 clinical trial units are designed to accommodate participants during the duration of the trial.

Depending on the study design, participants may stay at phase 1 trial units during short visits or permanently for some days.

These units provide various amenities to ensure the comfort and well-being of the volunteers or patients.

Participants have access to facilities such as comfortable beds, kitchen areas, living areas, large showers, and laundry services.

Additionally, high-speed Internet connectivity is available to keep participants connected with their loved ones and the outside world.

The units also include exam areas to conduct thorough medical evaluations of the participants.

Equipment and Expert Staff

To conduct phase 1 clinical trials effectively, state-of-the-art equipment and highly qualified staff are essential.

These units are equipped with advanced medical equipment, including refrigerated centrifuges, ECG machines, pulse oximeters, and telemetry devices.

The availability of a fully functional laboratory within the unit allows for diagnostic testing and participant monitoring.

The expert staff managing these units are experienced in conducting clinical research and ensure the safety and well-being of the participants throughout the trial.

Participant Population

Phase 1 clinical trial units —when conducting studies in healthy subjects— benefit from being located in areas with diverse populations, providing access to a wide range of volunteers.

These units are often situated in cities and communities with a healthy population of potential participants.

In some cases, access to special populations and senior citizens, can be crucial for specific research studies.

The inclusion of a diverse participant population allows for a more comprehensive evaluation of the experimental treatments and ensures that the findings can be generalized to a broader population.

The Role of Phase 1 Units in Drug Development

Phase 1 clinical trial units have successfully completed numerous trials across various therapeutic areas.

These trials have focused on a wide range of conditions, including hypertension, diabetes, rheumatoid arthritis, hypercholesterolemia, and lupus, to name just a few.

The expertise and experience gained from conducting these trials contribute to the continuous improvement of medical research and the development of new treatments.

The success of these trials has led to the approval and use of medications that are now considered standard of care in the treatment of specific diseases.

Sofpromed: A Leading CRO Offering Phase 1 Clinical Trial Unit Services

Sofpromed is at the forefront of early-phase clinical trial management, providing comprehensive phase 1 trial services and facilities in the United States, United Kingdom, Europe, and Australia.

We are a leading provider of phase 1 clinical trial services, offering a simplified and dedicated approach to early-phase studies.

Our partner phase 1 units provide support for the following investigations, among others:

  • First-in-human
  • SAD/MAD
  • PK/PD
  • Monoclonal antibodies/Biologics
  • Proof-of-concept
  • Bioavailability/Bioequivalence
  • Food effect
  • Drug-interaction

Sofpromed’s global network of partner clinics facilitates the execution of phase 1 clinical trials in different regions, complying with the unique regulatory requirements of each jurisdiction.

Our associated phase 1 units provide a patient-focused environment with state-of-the-art facilities.

The highly qualified staff and advanced equipment of our partner clinics enable the successful completion of trials across a broad range of therapeutic areas.

With access to diverse participant populations, including special populations, we can contribute to the advancement of medical research and the development of new treatments.

Conclusion

Phase 1 clinical trial units play a vital role in advancing medical research by testing the safety and efficacy of new therapies in human subjects for the first time.

These units provide essential amenities, advanced equipment, and expert staff to ensure the well-being of trial participants.

With access to diverse participant populations, phase 1 clinical trial units contribute to the development of inclusive and effective treatments.

Sofpromed offers comprehensive phase 1 study services and facilities to support the clinical development programs of biotech and pharma companies worldwide.

If you need the services of a phase 1 clinical trial unit in the United States, United Kingdom, Europe, or Australia, please contact us at info@sofpromed.com

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 

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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