CRO for Phase 1 Oncology Clinical Trials in the United States

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

4 April, 2022

CRO for Phase 1 Oncology Clinical Trials in the United States

If you need a CRO to carry out a phase 1 cancer clinical trial in the United States, please contact us at info@sofpromed.com 

Are you a biotechnology company planning a phase 1 oncology clinical trial in the United States? 

Do you need a clinical research organization (CRO) partner specialized in cancer trials? 

Sofpromed is an oncology-focused full service CRO with early-phase clinical trial management capabilities in the US. 

We are experts in assisting emerging biotech companies in the execution of early-stage (first-in-human and phase I) cancer clinical trials with drugs in the United States, with an extensive network of experienced clinical operations staff across the country.

Phase 1 Cancer Clinical Trials: Challenges and Recommendations 

Cancer clinical trials are complex from an operational perspective, and oncology is one of the most challenging therapeutic areas when it comes to study management.

Biotech companies developing anticancer compounds should count on the support of expert cancer CROs to develop their early-phase programs. This will ensure smooth operations and robust, high-quality data.

In particular, phase 1 oncology trials have their own set of inherent complexities, fundamentally related to the close monitoring needed in dose escalation, safety data reviews, and biological sample management involved in pharmacokinetics (PK) studies.

For example, when 3+3 dose escalation designs are used, patients have to be followed very closely to detect and report dose-limiting toxicities (DLTs).

Therefore, small biotech startups planning their initial phase 1 cancer trials should look for qualified oncology-focused CROs that can guarantee the successful conduct of the study from an operational standpoint.

Strong Oncology Expertise for Phase 1 Clinical Trials 

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

More specifically, we have very 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 

Hence, Sofpromed is a suitable CRO partner to conduct early-phase oncology clinical trials in the United States. 

Clinical Operations Staff with Extensive Cancer Experience

Sofpromed provides clinical operations professionals (e.g. clinical research associates —CRAs— and clinical project managers) to take care of clinical trial 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 in managing oncology clinical trials at some of the most prestigious cancer centers in the US, including both solid tumors and hematologic malignancies. 

We have seasoned local CRAs spread across the United States, from East to West, a reason for which we can manage clinical trials conducted anywhere in the country.

Full-Service CRO for Phase 1 Oncology Clinical Trials in the USA 

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

We propose a full service strategy, meaning that clinical trial sponsors can delegate to our team all the tasks and responsibilities involved in the execution of a clinical study, from study initiation to close-out, so that they can focus on their main business activities. 

Our CRO service list comprises the following:

  • Cancer center selection and activation in the US 
  • Clinical site management 
  • Onsite monitoring 
  • Drug safety monitoring 
  • Clinical data management 
  • SAS statistical programming 
  • Biological sample management for PK and translational studies 
  • Drug manufacturing and logistics 
  • Medical writing 

Cancer Center Selection and Activation in the US 

One of the great benefits of our offering is that we help trial sponsors identify the best cancer centers in the United States to execute their clinical studies, depending on the tumor type they are investigating.

Sofpromed has established a nationwide network of US cancer partner centers with reputed medical oncologists (key opinion leaders —KOLs—), so that site identification and selection can be quickly performed to shorten study start-up timelines.

Our clinical research personnel have extensive previous experience working with renowned oncology sites including (but not limited to): 

  • University of Texas MD Anderson Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Mayo Clinic
  • Dana-Farber Brigham and Women’s Cancer Center
  • Cleveland Clinic
  • Johns Hopkins Hospital
  • Northwestern Memorial Hospital
  • UCLA Medical Center

Thus, Sofpromed can ensure accelerated patient recruitment for cancer clinical trials in the US by providing these expert clinical sites, so that sponsors can complete their clinical studies within the planned timelines. 

Clinical Site Management 

Site management is the daily support that a CRO provides —typically through CRAs— to hospital staff regarding the procedures and regular operations of the study. For example, CRAs will help study coordinators solve doubts regarding patient enrollment or the management of biological samples. This support could also be needed by the site pharmacists when handling the study drugs. Site management support includes many different tasks but, in essence, seeks to help site staff with any question or problem they might encounter during the course of the trial.

Onsite Monitoring 

Onsite monitoring visits are performed by CRAs to review source data available at clinical sites. The aim is to verify that the data inserted in the study database matches the actual source data at the site. This procedure is known as source data verification (SDV). Sofpromed provides onsite clinical monitoring services for oncology clinical trials in all main US cities including New York, Los Angeles, Chicago, Houston, Phoenix, Philadelphia, San Antonio, and San Diego, among many others. 

Drug Safety Monitoring 

Drug safety monitoring is of special importance in phase 1 oncology trials, in which the assessment of drug-related toxicities is one of the main endpoints. Sofpromed can provide pharmacovigilance specialists in charge of receiving, reviewing, and reporting serious and non-serious adverse event forms to generate the corresponding safety reports. In addition, we provide qualified medical monitors in oncology, dedicated to evaluating the causality of safety events and providing expert guidance for the actions to be taken by the site staff and by the sponsor in each case.

Clinical Data Management and SAS Statistical Programming 

Sofpromed also offers cancer-focused, specialized data management and statistical programming services to ensure the best quality of data in your cancer trial, producing datasets and reports ready to be submitted to the Food and Drug Administration (FDA) of the United States. 

This means that we take care of the entire data management process applying industry standards such as CDISC, CDASH, and SDTM, from the initial data management plan, data collection specification documents, up to clinical database implementation, data cleaning, final analysis, and data submission to the FDA. 

The handling of clinical data includes statistical programming, which consists of writing programs (in SAS language) to generate data tables, figures, and listings (TFLs), with the results of the study.

In summary, our comprehensive data handling service portfolio allows biotech companies to focus on their core business, while having all the clinical trial data specified, collected, cleaned, analyzed, and submitted to regulators by an expert biometrics team. 

Biological Sample Management for PK and Translational Studies

Sofpromed knows that biotech companies developing cancer drugs in early stages often need to collect blood samples to perform pharmacokinetics studies (PK). The collection of these samples requires the provision of clinical kits (e.g. tubes) to obtain, process, store, and ship these samples to central laboratories for central analysis. Additionally, cancer trials may include the collection of tumor tissue to carry out translational studies (experiments to identify predictive biomarkers of treatment efficacy).

Drug Manufacturing and Logistics 

Sofpromed understands that biotech companies conducting oncology trials 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 hospital pharmacies in the context of clinical trials. 

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

Medical Writing 

If needed, Sofpromed can provide medical writing capabilities to produce key documents in clinical trials, such as the study protocol, the patient information sheet and the informed consent form (PIS-ICF), the Investigator’s Brochure (IB), the Investigational Medicinal Product Dossier (IMPD), and the final Clinical Study Report (CSR), among others. 

The Best Digital Tools for your Phase 1 Cancer Study 

As a technology-based CRO, Sofpromed facilitates the adoption of industry-leading web applications for clinical trial management. This includes the provision of key trial software tools, such as Electronic Data Capture (EDC) systems, electronic Trial Master File (eTMF), and DICOM image cloud applications needed for the central review of CT scans and MRIs in the context of solid tumor studies. 

Advantages of the Full Service CRO Model for Emerging Biotech Companies 

Sofpromed is the ideal partner CRO for small-sized biotech companies. Our upper management, clinical operations, and biometrics teams are highly responsive and we perfectly understand the particular needs of biotechnology startups immersed in the early stages of cancer drug development. Our CRO is the perfect match for small biotech companies as we are committed to meeting their specific needs (e.g. responsiveness, personal proximity, affordable price, among others). 

Get CRO Support to Run Your Phase 1 Cancer Clinical Trial 

Do not hesitate to contact us if you need support to run your next phase 1 oncology trial in the USA.

If you need a CRO to carry out a phase 1 cancer clinical trial 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