Oncology

George Clinical’s oncology scientific advisory committee actively participates in the design and delivery of trials to meet the increasingly complex and specialized demand of modern oncology research.

Oncology Trials

George Clinical has conducted more than 365 oncology studies in more than 12 indications

As a leader in the design and delivery of care-based, oncology research, George Clinical has access to significant global investigator networks and assembles experienced trial management teams, oncology experts, scientific leaders, as well as world-class health economics and statistics leaders with expertise in large, multi-regional datasets, to implement studies across a wide range of tumor types, hematological diseases and the latest immunotherapies. George Clinical is uniquely placed to meet the increasingly complex and specialized demands of modern oncology research and as such demonstrates product value in terms of clinical effectiveness, specialized cohorts and tolerability. George Clinical has extensive experience in all phases of oncology programs including, MTD, early Phase I, II and III, late-phase trials, health economics and outcomes research and has conducted more than 365 oncology studies in more than 12 indications.

 

 

Webinar: Managing Oncology Trials in the Era of COVID-19

As COVID-19 continues to change the clinical trial landscape, innovations in site and patient engagements will help determine the success of oncology trials.

Watch in the above video as Dr. Ari VanderWalde, a member of George Clinical’s scientific leadership team with oncology clinical research expertise, gives an in-depth understanding of preparing safe and efficient trials and implementing best practices to mitigate disruption during COVID-19 restrictions.

Topics covered in this webinar:

    • Explore the various risks and benefits of patients with cancer receiving oncology care during COVID-19
    • Review strategic considerations for undertaking new cancer clinical trials during the pandemic
    • Plan for how research will change under the “new normal”

 

 

 

Case Study: George Clinical Guides Sponsor with Limited Clinical Trial Experience in Phase II Melanoma-TIL Trial

Proactive identification of issues potentially affecting trial outcome led George Clinical to step in and provide services above and beyond original statement of work with full services, from protocol amendment to expanding manufacturing capabilities and easing patient waiting times.

George Clinical was contracted by a small biotechnology company for a Phase II, multi-center, single-arm study to assess the safety and efficacy of cell transfer therapy using autologous tumor infiltrating lymphocytes (TIL) followed by IL-2 treatment of patients with metastatic melanoma.

As George Clinical has conducted over 300 oncology studies, we were a good fit for a small company with limited clinical trial proficiency and in the process of rapid expansion of their clinical trial team. Our extensive experience includes all phases of oncology programs including, Maximum Tolerated Dose (MTD), Phase I, II and III and late-phase trials, health economics and outcomes research. Our full services team is comprised of scientific leaders, doctors, nurses, biostatisticians and trial management professionals who work together to ensure timely delivery of quality trial data. Our scientific leadership model is recognized internationally as being highly effective in helping sponsors implement the most effective trials possible with innovative solutions that produce quality outcomes within tight timelines and limited budgets.

Read more here, or download our case study.

 




Free Download of the George Clinical Melanoma-TIL Trial Case Study

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Services:

Program / Protocol Design

George Clinical’s scientific leaders are recognized globally as experts in their therapeutic areas. Our experts are highly skilled in collaborating with study sponsors to develop customized programs and protocols that meet regulatory and sponsor requirements.

Scientific Leadership

In the traditional study operations model, site engagement is typically performed by clinical research associates (CRAs). With George Clinical’s scientific leadership model, we provide a framework that enables active peer-to-peer communication and action pathways between global scientific committee members, national scientific leaders and principal investigators.

Project Management

Our highly experienced project management team oversee all functional areas and vendors across the lifecycle of a trial. We provide comprehensive project management services from single-country post-marketing studies to global registration studies (and everything in between).

Clinical Monitoring

George Clinical has an exceptional track record in risk-based clinical trial monitoring that ensures scientific excellence and data integrity across all sites. Comprehensive monitoring plans are crafted to address trial complexity and sponsor requirements, and often combine traditional monitoring visits with robust site management and remote monitoring tactics.

Regulatory Services

The George Clinical network allows GC to identify, analyze and react in real-time to regulatory change. Potential areas of risks and impact for our sponsors is rapidly communicated, with mitigation strategies to ensure local compliance of all clinical development and trial activity.

Medical Monitoring

Our medical monitors come from diverse therapeutic backgrounds and have the clinical and research expertise required to provide rigorous medical oversight of clinical trials.

Safety Services

George Clinical’s safety and pharmacovigilance experts ensure that a patient’s safety is paramount. Critical to the success of any clinical trial is the early identification and management of adverse events.

Data Management

Our highly experienced Data Management team have a wealth of industry experience from contract research organizations, to biotech, medical device and pharmaceutical companies.

Statistics

The George Clinical statistics team has extensive experience in the design and analysis of clinical trials, including adaptive designs. Our statistics team are familiar with a wide range of therapeutic areas.

Health Economics

George Clinical’s Health Economics team provide an expert, customized service to medical device and pharmaceutical companies who are increasingly expected to provide comprehensive evidence regarding the economic benefit of their product, not just efficacy and safety data.

 

George Clinical's Oncology Trials Scientific Leadership

Dipti Talaulikar

  • Senior Consultant, Hematology, Canberra Hospital and Associate Professor, ANU

Associate Professor Dipti Talaulikar is a Senior Consultant in Clinical and Laboratory Hematology at Canberra Hospital and Associate Professor at the Australian National University (ANU). She is also a long-standing member of Myeloma Australia’s Medical and Scientific Advisor Group, as well as other leading cancer trial and research groups. She is dedicated to improving patient wellbeing and has authored both national and international clinical practice guidelines that have had a significant impact on cancer patient care. She has also served as Principal Investigator and co-investigator of several lymphoma, leukemia and myeloma trials.

Dr. Talaulikar contributes to medical workforce development and advocacy for equity of access to diagnostic tests and blood cancer treatments through leadership roles in organizations such as Royal College of Pathologists of Australasia (RCPA), National Blood Authority and Myeloma Australia. She is recognized as a key opinion leader (KOL) and is regularly invited to participate in Advisory Boards of pharmaceutical companies to provide guidance into clinical development of drugs, feedback into trial protocols and insights into research opportunities.

Primary research interests include breast cancer, supportive care and developmental therapeutics. Recently involved with genomic profiling of advanced cancer. Interested in visionary approaches to clinical research and oncology science. Divides his time between individual patients in the clinic and conducting clinical research trials and programmatic development.

Dr. Ari VanderWalde is an internationally recognized researcher providing expertise in oncology clinical trials with a focus on immune therapies in solid tumors and melanoma. He has worked in the pharmaceutical industry helping lead the approval of a new compound in Melanoma. Along with this experience, he also works at a premier cancer research institute and as a scientific expert in a global CRO specializing in oncology. 

In addition, Dr. VanderWalde has collaborated and participated on advisory boards with many of the nation’s thought leaders and top experts in the field and holds a dual appointment with the University of Tennessee Health Science Center as Associate Vice Chancellor of Research and Assistant Professor, Hematology/Oncology. He is involved in research that can improve treatment for cancer patients by targeting therapy in a more personalized fashion based on immune markers and aberrations in cancer genetics.

Specializes in medical oncology, hematology and blood cancers. Interested in research and immunology. Committed to providing patients with access to early-stage clinical trials. In partnership with Methodist Healthcare, facilitated FDA approval for lifesaving CAR T therapy in 2019.

Board certified in both hematology and oncology. Has a research interest in cancers of the blood and blood-forming tissues as well as solid tumors, such as those seen in bladder cancer. Conducts research in exploring the latest advances colorectal cancer treatment. Offers individualized care to patients with focus on multi-modal treatment regimens.

Specializes in offering comprehensive care including advanced genomic and immunotherapy treatments to women with metastatic breast cancer. Advises patients on participating in clinical trials for leading-edge treatments. Emphasizes the importance of in-depth communication with patients taking a fully holistic approach to their treatment options.

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