Are you a biotechnology startup company seeking contract Clinical Research Associates (CRAs) for oncology clinical trials in the United States?
Sofpromed provides senior CRAs to biotech companies executing phase I-IV oncology trials in the U.S. through an independent contractor scheme.
In this article, you can learn how our oncology-focused CRAs can assist with your cancer study and how you can hire their services.
Contract Monitors with More than 10 Years of Industry Experience
All the CRAs we provide are highly-experienced clinical research professionals with at least 10 years of experience in monitoring cancer clinical trials in the US.
Our CRAs have strong industry expertise working with both small biotech and big pharma companies in early-phase trials as well as in late-phase pivotal or registration studies.
As cancer expert CRAs, our monitors can work independently in close coordination with the Sponsor’s clinical project managers, thus guaranteeing high-quality remote and onsite operations across the US territory.
Oncology-Focused CRA Services
Sofpromed’s CRAs are specialized in managing a wide range of tumor histologies in the context of commercial trials and investigator-initiated studies.
Our CRAs have acquired substantial expertise in handling clinical trials that recruit patients with the following tumors:
- Breast cancer
- Non-small cell lung cancer (NSCLC)
- Ovarian cancer
- Melanoma
- Sarcomas
- Brain tumors
- Gastrointestinal cancer
- Biliary tract cancer
- Pancreatic cancer
- Colorectal cancer
- Prostate cancer
- Acute myeloid leukemia
- Lymphoma
- Non-Hodgkin’s lymphoma
The tumor-specific knowledge of our CRAs —including rare cancers— ensures data quality and regulatory compliance regardless of study size.
Previous Experience with the Best US Cancer Centers
Sofpromed’s CRAs have monitored hundreds of sites across the United States, including the best known cancer centers in the country, such as:
- MD Anderson Cancer Center, Houston
- Memorial Sloan Kettering Cancer Center, New York
- Dana-Farber Cancer Institute, Boston
- Mayo Clinic, Rochester and Phoenix
- The Johns Hopkins Hospital, Baltimore
- Cleveland Clinic, Cleveland
- Massachusetts General Hospital, Boston
- The Mount Sinai Hospital, New York
Due to the strong professional relationships built over the years with these and other institutions, our CRAs are in a highly strategic position to begin new clinical trials with these hospitals in the oncology area.
Strategic Partnerships with US Medical Oncologists
Through the years, Sofpromed’s CRAs have established valuable relationships with medical oncologists at various US sites. Many of these investigators are prestigious key opinion leaders (KOLs) in specific cancer types. Hence, Sofpromed can easily involve these KOLs in the cancer study proposed by the Sponsor. These professionals will play the role of coordinating investigators, principal investigators, or members of Data and Safety Monitoring Boards (DSMBs).
Fast Site Feasibility and Selection Process
The wide oncology trial experience gained by Sofpromed and its CRAs enables quick hospital and principal investigator selection. After many years of conducting clinical trials at sites, we have got to know very well which sites are good recruiters of patients with specific cancers. This vast knowledge saves time and money when it comes to finding and choosing sites for a new clinical study.
Onsite Monitoring Capabilities Across the US
Sofpromed’s CRAs are strategically located across the US territory, from the East to the West coast, including the majority of States, so we can assign the most appropriate CRA to the study depending on site location. This CRA allocation based on geographic area greatly improves the efficiency of clinical operations and results in significant savings when it comes to the travel costs involved in onsite monitoring visits.
What Services Do Our CRAs Provide?
Our CRAs can provide the following services and capabilities:
- Contribute to the selection of potential sites and investigators.
- Perform Site Qualification, Site Initiation, and Site Close-Out Visits.
- Train, support and advise Investigators and site staff in study-related matters.
- Confirm that site staff have completed and documented the required trainings appropriately. Ensure that sites and inspections are ready at all times.
- Contribute to Investigators’ meetings, as applicable.
- Share information on patient recruitment and study site progress (site quality/performance).
- Identify and ensure timely resolution to study-related issues and escalate them as appropriate.
- Update CTMS and other systems with data from study sites.
- Manage study supplies (ISF, etc), drug supplies and drug accountability at study sites.
- Perform monitoring visits (remote and onsite), as well as remote data reviews.
- Perform Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), according to the Monitoring Plan.
- Ensure data query resolution in a timely manner.
- Work with data management to ensure robust quality of the collected study data.
- Prepare and finalize monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letters.
- Follow up on outstanding actions with study sites to ensure resolution in a timely manner.
- Follow quality issue processes by escalating systematic or serious quality issues, and data privacy breaches.
- Assist site in maintaining inspection-ready Investigator Site File (ISF).
- Prepare for and collaborate with the activities associated with audits and regulatory inspections.
- Ensure timely collection/uploading of essential documents into the electronic Trial Master File (eTMF).
- Ensure compliance with local and national legislations, as applicable.
How Are Sofpromed’s CRAs Hired?
Hiring Sofpromed’s CRAs in the United States is a straightforward process. Our US CRAs are hired through an independent contractor model. First, get in touch with one of our representatives to explain your specific requirements. How many CRAs do you need? What full time equivalent (FTE) dedication is required? What is the duration of the contract? Whether you need a Monitor for 3 or 24 months, or just to conduct some specific visits, our contracting model will be flexible enough to adapt to your requirements.
If you need contract Clinical Research Associates (CRAs) for oncology clinical trials in the U.S., please contact us at info@sofpromed.com
