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.
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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
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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.
