CRO for Clinical Trials in the United States

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

28 July, 2021

If you need a CRO to carry out a clinical trial in the US, please contact us at info@sofpromed.com

Are you a biotechnology or pharmaceutical company planning a clinical trial in the United States?

Sofpromed is a clinical research organization (CRO) with clinical trial management capabilities in the US.

We assist biotech and pharma companies worldwide in executing phase I-IV clinical trials with drugs and medical devices in the United States.

We can handle clinical trials across multiple therapeutic areas and we have particularly strong expertise in oncology trials.

Full-Service CRO for Phase I-IV Clinical Trials in the USA

Sofpromed provides a wide spectrum of CRO services to conduct clinical trials in the United States.

We offer a full service approach, meaning that clinical trial sponsors can delegate on us all the tasks and responsibilities involved in running a clinical study.

Our CRO service catalog includes:

  • Regulatory affairs
  • Site selection and activation in the US
  • Clinical site management
  • Onsite monitoring
  • Clinical data management
  • Biostatistics and statistical programming
  • Pharmacovigilance
  • Drug logistics
  • Biological sample management
  • Medical writing
  • Project management

One of the added values of our offering is that we help trial sponsors identify the best hospitals and clinics in the United States to run their clinical trials.

We also provide local regulatory and clinical operations staff (e.g. regulatory specialists, clinical research associates, clinical trial assistants, clinical project managers) to take care of clinical trial start-up, reporting, monitoring, and site management tasks in hospitals located across the US.

Our clinical operations personnel are highly experienced with an average of more than 10 years of expertise managing clinical trials.

We have local clinical research associates spread across the United States, so that we can manage clinical trials conducted in most US clinical sites.

We can provide onsite clinical monitoring services in all main US cities including New York, Los Angeles, Chicago, Houston, Phoenix, Philadelphia, San Antonio, and San Diego, among many others.

In addition, we offer specialized data management and statistical programming services to ensure the best quality of data in your clinical trial, ready to be submitted to the FDA. 

This means that we take care of the entire data management process, from the initial data management plan, data collection specification documents, up to clinical database implementation, data cleaning and final analysis.

In summary, our comprehensive service portfolio allows biotech companies to focus on their core business, while having the whole clinical trial organized, coordinated, run, and analyzed by an expert team.

Another advantage of this full service model is that the biotech company does not have to invest in building its own infrastructure and specialized clinical trial management departments, which reduces internal hiring and operational efforts.

Clinical Trial Management in the US in Multiple Therapeutic Areas

Sofpromed is able to manage clinical trials in the USA in multiple therapeutic areas, including the following, among others:

  • Oncology
  • Cardiovascular
  • Metabolic
  • Central nervous system (CNS)
  • Dermatology
  • Infectious diseases
  • Respiratory diseases

Although Sofpromed can handle trials in multiple diseases, we have particular expertise in managing clinical trials in cancer.

More specifically, we have strong experience in clinical trials with experimental treatments in:

  • Musculoskeletal tumors: Soft tissue and bone sarcoma.
  • Gastrointestinal stromal tumors (GIST).
  • Gynecological cancers: Ovarian and endometrial cancer.
  • Blood cancers: Leukemia, lymphoma, and myeloma.
  • Brain tumors: Glioma and glioblastoma.
  • Gastrointestinal cancers: Pancreatic, colorectal, and biliary tract cancer.
  • Genitourinary cancers: Prostate, bladder, and kidney cancer.
  • Lung cancer.
  • Breast cancer.

Therefore, Sofpromed is the perfect CRO partner to conduct oncology clinical trials in the United States.

Fast Patient Recruitment for Clinical Trials in the US

Sofpromed can ensure accelerated patient recruitment for clinical trials in the US by providing expert clinical sites specialized in enrolling patients affected by specific diseases.

Through a nationwide network of partner clinical sites, Sofpromed and its collaborators are able to facilitate access to top recruiting hospitals so that sponsors can complete their clinical studies within the planned timelines.

We can facilitate clinical sites with high-volume enrollment potential in the following states, among others: California, Texas, Florida, New York, Pennsylvania, and Illinois. 

Key Opinion Leaders (KOLs) for Clinical Trials in the USA

In addition to the best clinical sites, Sofpromed can also facilitate collaboration between clinical trial sponsors and key opinion leaders (KOLs) across multiple therapeutic areas.

Running clinical trials with KOLs ensures Good Clinical Practice (GCP) compliance and high quality study results, as the studies are conducted with top experts in the target disease.

Sofpromed can particularly provide KOLs in oncology, so trial sponsors can benefit from expert clinical feedback and fast recruitment in clinical studies including different tumor types.

Drug Manufacturing and Logistics for Your Clinical Trial in the United States

As part of its full service approach, Sofpromed understands that biotech companies not only need clinical trial management support but also services related to drug manufacturing and logistics.

Therefore, Sofpromed helps emerging biotech companies find the most suitable drug product manufacturer for their type of compound, and provides all the services required for drug product packaging, labeling, storage, and distribution to sites in the context of clinical trials.

Thanks to this comprehensive vision, biotech clients can use Sofpromed as a one-stop CRO vendor, minimizing the need to look for multiple providers. 

Get CRO Support to Run Your Clinical Trial

Sofpromed is a reliable CRO focused on providing full support to sponsors planning clinical trials in the US. 

We can manage your entire study (from phase I to late stage) from beginning to end, including clinical trial management aspects but also drug manufacturing, labeling, storage, and distribution to clinical sites.

Do not hesitate to contact us if you need support to run your next clinical trial in the US!

For more information about conducting clinical trials in the United States, 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