Our capabilities for quality and timely execution of Oncology clinical trials
- Team of experienced medical writers, medical monitors and subject matter experts (SMEs) help design robust clinical trial protocols and ensure regulatory compliance, enhanced patient enrollment & retention, and timely completion of the trial
- A Sound understanding and a proven regulatory track record with the US, India and with other regulatory agencies help us obtain the required permissions
- Trained and experienced study team assessing feasibility, site qualifications and on-boarding of right sites to complete the study with pre-defined timelines to ensure timely CSR delivery and dossier submission to regulatory agency
- Skilled study team for site management, tracking patient enrollment and site monitoring
- Robust initial and periodic training of the study team on critical aspects of the study, the procedures, assessments and anticipated safety aspects
- A team of data management experts, biostatisticians and report writers ensure timely delivery of regulatory-compliant study reports
Dr. Ravi Patel, CBCC SME - USA
- He is a board-certified medical oncologist and founder of Comprehensive Blood and Cancer Center (CBCC). He has done his MBBS from Government Medical College, India and did his residency in Internal Medicine at the University of Illinois (affiliated with Ravenswood Hospital). He was a Fellow in Hematology/Oncology at Loyola University, Stritch School of Medicine along with a combined affiliated program at Foster G. McGaw Hospital. The fellowship program included training on Bone marrow transplantation in addition to the Hematology/Oncology Program. Dr. Patel has been actively involved with the leading pharmaceutical manufacturers and academic research programs to assure that cancer patients in Kern County get unprecedented access to the cutting-edge medicines and treatment options available in the world. He is passionate about cancer care, research, global health, and philanthropic projects. For 30 years, Dr. Patel has continued to actively care for his patients and serve as a principal investigator on many of the Centre’s clinical research studies.
Dr. Chirag Desai, CBCC SME - INDIA
- Practicing for the last 20+ years, Dr. Desai has vast experience in oncology. He has been involved in treating adult, pediatric, geriatric, solid organ and hematological cancers. Being a clinical research consultant since 1999, he has participated in >75 clinical trials as a Principal Investigator and acted as a DSMB member of 5 industry-sponsored clinical trials. His work as a project manager for the Indian division of a large international CRO from 1998-1999; national co-ordinator for oncology trials and medical adviser for oncology from 1999 to 2005. Dr. Desai is also a member of several professional organisations such as ASCO, ESMO, ISMPO, ICON, IMA, AMA, APA and APG.
- We follow stringent criteria in selecting our study sites wind aim to generate high-quality data within competitive timelines
- CBCC owns 3 Oncology centers in the US & 6 in India and manages 3 oncology centers of Dignity Health in the US
- We have >160 oncology clinical trial sites in our database, and our site investigators and staff are highly trained in current regulatory requirements and have experience in multiple indications
- Our network of >100 sites in India and >60 sites in the US and access to > 10 partners with robust cancer care infrastructure and a team of >100 oncologists in the US help us provide the best patient care in this specialization
- We can support patient enrollment in China, Australia, and European countries through our partners
- We have premium site networks with prior experience in successful regulatory inspections
CBCC's experience in Oncology clinical trials
- Irrespective of your focus area and requirement of a simple or complex oncology area, our team can support end-to-end clinical trial execution. Our team has worked on >100 clinical trials in the US and > 20 clinical trials in India in Oncology
- Some areas in which our team has supported leading pharmaceutical and biotech companies for oncology drug development including Phase I/II/III and PK studies are:
Renal cell carcinoma
- CBCC has experienced in designing and executing both, early and late phase oncology trials. Our oncology team helps various pharmaceutical, biotech, and medical device companies accelerate the advancement of oncology therapies through clinical testing. Oncology research is becoming more and more competitive, and trial designs are increasingly becoming complex. An expert team of clinical researchers is essential for the success of your oncology therapy development programs.
- Our team of medical writers, regulatory experts, oncologists, SMEs, statisticians, data management and clinical operations team will help you achieve your organizational goals of delivering high quality and efficient oncology therapies for the patients. Irrespective of the study size and duration, be it a small, early-phase trial focused on a single region or a study requiring global patient recruitment, our team will work collaborate with you and help you overcome high-risk, high-cost, time-intensive challenges of oncology drug development.
At CBCC, we support oncology drug development in multiple ways
- Early phase trials
Pharmacokinetic and safety studies in healthy subjects when scientifically and medically justified
Pharmacokinetic and safety studies in cancer patients when study in healthy subjects is not scientifically and medically justified
Pharmacokinetic studies for ANDA and MAA
Other early phase clinical studies like QT/QTc studies, DDI studies, SAD/MAD studies etc.
Proof of concept studies
Early safety and efficacy studies
Helping the development and validation of Bioassays for oncology drug development
Identification and validation of suitable biomarkers
- Late Phase Trials
Therapeutic confirmatory trials
Phase 4 oncology trials
CBCC’s value addition in drug development
- We are well-placed to support all your clinical development programs for both, simple and complex oncology indications.
- We can support you to:
Design scientifically sound, regulatory compliant and medically corroborating clinical trial programs for NCEs, 505b2s and ANDA submissions
Get easy access to KOLs in drafting robust protocols and clinical development plans
Manage projects and facilitate all regulatory activities including USFDA communications
Select the right sites with high patient pool to expedite patient enrollment
Manage multi-country patient enrollment from site selection to close-out
Generate high-quality data at sites through optimum monitoring plans
Ensure continuous support during post-study regulatory inspections