For Sponsors

At GCRI, we provide quality clinical data through timely enrollment of study participants and timely and  meticulous documentation. Staff members are trained in Good Clinical Practices (GCP) and are also highly experienced in the field of oncology. Having staff members with extensive clinical operations experience from the biotechnology and pharmaceutical industry also ensure the highest degree of compliance with the requirements of our Sponsors.

GCRI is partnering with 4 community hospitals in the South Bay and several large community oncology practices to provide clinical trial services to thousands of patients.  GCRI also has dedicated interventional radiologists, radiologists, surgeons and cardiologists knowledgable in clinical trial conduct to provide necessary procedures as required by clinical protocols.  The infusion center at GCRI is dedicated to the treatment of clinical trial patients. The treatment staff can provide IV infusions and oral medications as well as obtain pharmacokinetic, pharmacodynamic and other specimens required during treatment and observation periods.  

The Clinical Research Nurse is responsible for protocol management, communication with study sponsors and patient care.  She works closely with Dr. Bui and Dr. Ahuja and maintains constant communication with study Sponsors, Dr. Bui, Dr. Ahuja, clinical staff and patients regarding patient screening, enrollment, education and patient follow up.

Using state-of the-art wireless technology and a proprietary electronic data capture system, Dr. Bui and her staff are able to assess patients at bedside to document, grade, attribute adverse events, and enter the data digitally into our electronic medical record (EMR). This permits accurate assessment at point of contact.

GCRI’s data management team consists of experienced Clinical Research Assistants (CRAs) that are responsible for paper and electronic case report form (CRF) completion, and query resolution. The team is highly knowledgeable with the latest electronic data capture (EDC) systems available, including Medidata Rave, InForm, Synteract Data Capture, Omnicom, and Oracle Clinical.  GCRI will also have access to a proprietary EDC system which pulls patient data directly from GCRI's EMR system, thereby decreasing the need for source verification and queries and increasing the quality of the data captured onto eCRFs. Sponsors will also have direct, real-time online 24/7 access to the eCRFs and HIPAA-compliant (only the patient ID number will be shown) source documents from the EMR system.The team is held to the highest standards to ensure a quality and timely clinical trial data product for the study sponsors. Our data management team undergoes quality and timeliness assessment with the study sponsor during and at the end of every study to ensure quality standards are maintained.

 

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