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Submit NowOncology
Our capabilities for quality and timely execution of Oncology clinical trials
- Medical adviser/KOL with >3 decades of experience in the Oncology area
- Multiple quality checks at each stage of clinical study
- Access to sites with databases of Oncology patients with an excellent regulatory track record
- Management of complex drug supply to multiple sites
- Effective site distribution and naïve site development in competitive studies to avoid recruitment challenges
Experience
- Metastatic breast cancer
- Hodgkin’s lymphoma
- Renal cell carcinoma
- Colorectal cancer
- Prostate cancer
- Ovarian cancer
25+ early phase studies on complex injectable and solid oral formulations across 150+ sites
Ten 505(b)(2) programs ranging from early phase trials to complex phase III trials
Sample size ranging from 16 to 120 patients
Patient drop-out rate of <10%
Rescue PK study with start-up activities completed in <1 month
Scientific Advisory Board
Dr Ravi Patel
Dr Ravi PatelFounder & Managing Director, Comprehensive Blood & Cancer Center
Ravi Patel, MD, is a board-certified medical oncologist. He has done his MBBS from Government Medical College, India, and residency in internal medicine from the University of Illinois (affiliated to Ravenswood hospital). He completed his fellowship in Hematology/Oncology from Stritch School of Medicine, Loyola University alongside a combined affiliated program from the Foster G. McGaw hospital. The fellowship program included bone marrow transplantation training and a combined Hematology/Oncology program.
Dr. Patel founded Comprehensive Blood and Cancer Center (CBCC) that grew from a 1200 square feet office to a comprehensive, community-focused diagnostic, educational, and research-based cancer center. Dr. Patel planned to affiliate CBCC with the UCLA School of Medicine. Working with the UCLA research consortium, UCLA employees managed clinical trials alongside the center’s research staff. Several treatments that were tested at CBCC were profoundly successful and have been submitted to the Federal Government’s Food and Drug Administration (FDA) for approval. These breakthrough treatments have made it possible to manage and cure many forms of cancer globally.
For the last 30 years, Dr. Patel has been actively caring for his patients and has been serving as principal investigator in many clinical research trials at CBCC. He is globally involved with the leading pharmaceutical manufacturers and academic research programs to ensure that cancer patients in Kern County have access to the most cutting-edge medicines and treatments available across the world.
Dr Chirag Desai
Dr Chirag DesaiFounder Director, Vedanta Institute of Medical Sciences
Dr Chirag Jyotiker Desai has achieved his MBBS, MD, DM (Oncology) from Gujarat University, Ahmedabad, India. Currently, he is the Consultant Medical Oncologist and Founder Director, Hemato-oncology Clinic at Vedanta Institute of Medical Sciences. Here he is involved in activities including Clinical care of the cancer patients, Clinical research activities and Educational activities.
Under Clinical Care, he is recognized as a KOL by the oncology fraternity and the industry. He has worked closely with a team comprised of surgical and radiation oncologists, radiology and pathology colleagues and other specialists as required as well as involved in planning the treatment and execution of chemotherapy protocols. He also plans institutional protocols for the treatment of cancer.
His clinical research activities include his role as a Principal or sub-investigator in more than 75 clinical trials, where most of them are for USFDA or EMEA submission. He has been a DSMB member of 5 industry-sponsored clinical trials including one study in vaccine and one in NCE. He is a Steering committee member for 3 industry-sponsored clinical trials including 2 early-phase trial of NCE/NBE and a Consultant/Advisor to 4 Indian CROs. He has played the role as a subject expert to 2 Indian Pharma companies in their biosimilar development. He has been invited as a subject expert by pharma companies while presentation to SEC at CDSCO office. He is a member of disease guideline committee for Lung Cancer and Tongue Cancer for Indian Council for Medical Research (ICMR) and also of Scientific Advisory Board of iBioAnalysis – a company in collaboration with Department of Science and Technology of Govt. of India.
His various Educational activities involve an invitation as a faculty for most oncology events in the country and the region. He is also involved as a moderator, debater, guest lecturer, a mentor for oncologists in training and the clinical research professionals working in pharma companies/CROs to train them in oncology therapeutic area and GCP. His mentorship has also been helpful to the medical and communication departments of Indian as well as multinational pharma companies for their existing products and new launches; investigators/ colleagues and ethics committee members in GCP. He is also a member of the editorial board of 4 Indian/Regional oncology journals. He has mentored about 35 MPharm or MSc Life Science students in their 4th term short research project for their thesis and played a role as an External Evaluator for PhD for Tata Memorial Center students.
Dr Desai is affiliated with CIMS Hospital, Ahmedabad since 2014. His past affiliations include Sterling Hospital – Ahmedabad, HCG Cancer Center – Ahmedabad and Apollo CBCC Cancer Center Ahmedabad.
Dr Desai has worked as an Advisor/Consultant – Oncology Therapeutic Area Programs, National Oncology Coordinator and Project Manager for Quintiles Spectral India Ltd, Ahmedabad. He has worked as a Director for VIBGYOR Scientific Research, Ahmedabad from 2006 to 2011.
At Vibgyor and Quintiles, being an in-house oncology resource person he was responsible for the evaluation of the projects, selecting the investigators, site selection, site initiation, training of the CRAs, overseeing the monitoring from the scientific viewpoint, making the budget and agreement with the sponsor and the sites, ensuring the clarity of the interpretation of the protocol with the sponsor and the investigators.
As his career objective, he believes that there is a large room for improvement in cancer therapy and the dire need of innovations. He wishes to be a part of the improvement in the therapeutics against cancer and allied diseases. Having the necessary background of internal medicine and oncology, with experience in clinical research and clinical practice, he believes that he is in the position to ensure the correct drug being investigated with the correct methodology. This includes a thoughtful protocol, effective route and schedule of administration, a realistic endpoint, feasible target in terms of efficacy, ensuring safety and recruiting an adequate number of patients.
He is the founder member of Indian Collaborative Oncology Network (ICON), an active member of the American Society of Clinical Oncology (ASCO) and a full member of European Society for Medical Oncology (ESMO). He is a life member of Indian Society of Medical and Pediatric Oncology, Indian Medical Association (Ahmedabad Branch), Association of Physicians of Gujarat and Association of Physicians of Ahmedabad.
Strategic Role of CROs in Oncology Clinical Trials
Clinical trials have become pivotal to drive innovation in cancer care. These scientifically rigorous studies evaluate novel therapies, pharmaceuticals, and treatment protocols to determine their safety and efficacy. These trials not just lead to the advancement of global scientific standards in oncology but also improve patient lives by giving them early access to advanced therapies.
At CBCC Global, we are committed to revolutionize cancer treatment through expertly designed and efficiently executed oncology clinical trials. Our efforts support the development of chemotherapy, targeted therapies, immuno-oncology agents, biosimilars, and personalized medicine approaches.
Cancer clinical trials play a pivotal role in discovering new methods to diagnose, treat, and prevent malignancies. These trials offer hope to patients, especially those with treatment-resistant or advanced-stage cancers. By validating emerging therapies under controlled conditions, clinical trials contribute to improved survival rates, better quality of life, and a deeper understanding of cancer biology.
Early-phase studies explore safety and dosage levels, while late-phase trials compare novel treatments against existing standards of care or historical data. These phases of clinical trials are crucial in identifying the safest and most effective therapies so that they reach the wider medical community.
The success of clinical trials for cancer integrally depends on oncology-focused Contract Research Organizations (CROs). They bring scientific, operational, and regulatory expertise to the entire clinical development process. These organizations manage complex trial logistics, coordinate multi-site operations, communicate with regulatory bodies and ensure adherence to international guidelines. By streamlining processes and maintaining strict quality controls, oncology contract research organizations minimize delays and reduce the risk of trial failure. They also act as a vital bridge between sponsors, investigators, and regulatory bodies, ensuring seamless communication and alignment across all trial stakeholders.
Key functions of oncology CROs include:
- Clinical Protocol Development: Designing scientifically robust and regulatory-compliant study blueprints.
- Patient Recruitment and Retention: Implementing strategic outreach initiatives and support systems.
- Regulatory Submissions: Handling communications with ethics committees and regulatory bodies.
- Data and Safety Monitoring: Conducting real-time safety evaluations and quality assurance.
- Results Analysis and Reporting: Performing statistical analyses and facilitating peer-reviewed publications.
India's oncology trial landscape is growing rapidly due to its genetic diversity, modern infrastructure, and cost-effective operational environment. With a large and treatment-naive patient base, India is well-suited for both early- and late-phase oncology studies. The country also offers access to trained investigators, NABH-accredited hospitals, and centralized ethics committees.
CBCC Global leverages this environment through strategic site selection and culturally adaptive trial management, making it an ideal partner for sponsors looking to conduct efficient, high-quality cancer clinical trials in India.
Oncology trials often encounter barriers such as limited patient enrollment, complex regulatory landscapes, and high attrition rates. CBCC Global mitigates these challenges by integrating advanced technologies and evidence-based methodologies into its trial design and execution.
Our tailored oncology solutions include:
- Recruitment for Rare Indications: We utilize AI-driven matching tools and regional registries to enroll hard-to-reach patient populations.
- Accelerated Market Readiness: We reduce go-to-market time by deploying adaptive trial designs and interim data reviews.
- Patient-Centered Approaches: Our protocols incorporate patient-reported outcomes and flexible scheduling.
- Predictive Safety Monitoring: Early identification of adverse events via integrated risk-based monitoring platforms.
- Post-Trial Scalability: Support for transitioning successful treatments into large-scale commercial deployment.
CBCC Global offers an array of oncology clinical research services spanning the entire drug development lifecycle. With decades of experience, we manage complex oncology studies in solid tumors and hematological malignancies, including:
- Metastatic breast cancer
- Pancreatic cancer
- Hodgkin’s lymphoma
- Renal cell carcinoma
- Colorectal cancer
- Prostate cancer
- Ovarian cancer
- Lung cancer
- Head and neck cancer
- Acute myeloid leukemia and acute promyelocytic leukemia
- Myelodysplastic syndrome
Our specialized teams cover:
- Medical Affairs: Expert physicians ensure therapeutic alignment and protocol viability.
- Regulatory Affairs: Assistance with IND submissions and regulatory consulting.
- Clinical Operations: Seamless workflow transition from site initiation to monitoring to study logistics.
- Biostatistics and Data Management: Sophisticated analysis for interim and final reporting.
We also offer pharmacovigilance support, centralized project oversight, and strategic feasibility studies. Our infrastructure supports both traditional and decentralized trial models, ensuring flexibility in response to evolving sponsor needs. With over 25 early-phase studies and 10 completed 505(b)(2) programs, our track record underscores our ability to deliver reliable data and efficient trial outcomes.
CBCC Global offers unparalleled support for oncology research through:
- Veteran Leadership: A leadership team with over 30 years of oncology-specific experience.
- Site and Patient Access: A huge network of more than 150 trial locations and reliable patient retention (drop-out rate: <10%).
- Expedited Study Timelines: Rapid start-up capabilities, including rescue pharmacokinetic studies completed in under a month.
- Full-Spectrum Services: Seamless support from preclinical strategy to regulatory submission and beyond.
Our collaborative model promotes efficiency, data integrity, and regulatory success, positioning your therapy for long-term clinical and commercial success.
FAQs
Oncology clinical trials are structured research studies designed to evaluate the safety, efficacy, and dosage of novel cancer therapies before regulatory approval and widespread use. These trials are vital in shaping cutting-edge cancer treatments.
They provide patients with access to cutting-edge therapies, including targeted drugs and immunotherapies, that may outperform existing treatments. CBCC Global specializes in early-phase trials and 505(b)(2) programs that offer rigorously monitored, high-quality care.
Oncology contract research organizations manage all operational aspects of cancer clinical trials, ensuring adherence to ethical practices, regulatory requirements, and study timelines. CBCC Global has over 150 active trial centres with patient retention rates that are among the best in the industry.
Yes. They are conducted under stringent regulatory oversight with multiple checkpoints for safety and quality. To ensure the safety of patients, CBCC Global deploys highly experienced personnel for medical supervision along with ever-vigilant monitoring systems.
You may consult healthcare providers, clinical trial registries, or get in touch with CBCC Global’s network of trial centers. Our teams will make sure you receive compassionate, specialized care by guiding you through the enrollment process.
There are 4 phases of oncology clinical trials (Phase I-IV). They are designed to assess the safety, effectiveness, and long-term impact of a novel treatment. CBCC Global has led over 25 early-phase studies and managed pivotal Phase III trials with proven success.
High retention improves data reliability and regulatory approval likelihood. CBCC Global achieves a <10% drop-out through robust patient engagement and supportive site management.
We implement stringent quality checks at each study stage. Our experienced advisors and rigorous SOPs ensure protocol fidelity, ethical standards, and accurate data collection.
Our focus areas include solid tumors such as breast, prostate, colorectal, ovarian, renal, pancreatic, lung, and hematologic cancers such as AML, MDS etc. We support targeted therapies and precision oncology through carefully designed trials.
By refining drug mechanisms, validating combinations, and generating critical safety and efficacy data, oncology trials accelerate drug approvals. CBCC Global ’s success in 505(b)(1) and 505(b)(2) trials exemplifies our ability to streamline development and maximize therapeutic impact.
