Oncology CRO & Clinical Trial Services

ARG Has The Oncology Experience To Successfully Manage Your Clinical Trials

Oncology Clinical Trial Challenges:

  • Is your trial front and center in a busy site?
  • Does your CRO have CRAs who understand cancer research and treatment modalities?
  • Does the contract research organization team understand complex protocols?
  • Are you getting responsive collaboration from your study partner?
  • Is every patient in every clinical trial valued?
Oncologists search for a cure

Our Team Uses Best Practices in Clinical Research Projects

ARG thrives with both inexperienced and veteran Sponsors because we are driven by ideas and relationships, regardless of project. We understand often there is no clear path in clinical research, so we rely on people with profound oncology experience. Because our monitors are fully engaged in the clinical research process, we have consistently demonstrated the capacity to notice details, share observations, and solve problems.

Our tight, smart, and flexible clinical operations team combines with the Sponsor’s staff members to make one clinical trial team. All of this is possible because, for ARG, every patient in every study is vital.

Oncology White Papers: Science and Technology

Early Phase Oncology CRO Clinical Trial Services

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“Sponsors trust us because they know we have their backs regarding ideas, budgets, and milestones. Relationships are built on delivering successful projects over time.”

“I really enjoy the science, the gene therapy, the precision medicine in oncology. There is always something new to learn. These treatments offer promise for so many cancer patients. Working in cancer research is not for everyone because it is life and death for these kids. But it is the science and hope that sustains me. I am not alone; we have a like-minded clinical operations team that works together with our Sponsors.”

Catherine Allen, Oncology Project Manager
Catherine Allen, Oncology Project Manager

Oncology Academy: Team and Organization Know-How

ARG firmly believes that the CRO staff play a critical role in ensuring the success of each clinical research project that we undertake. To provide assurance to our sponsors that clinical trials staff are fully competent and optimally prepared to undertake the research entrusted to us, ARG has developed a training and development program, the ARG Oncology Academy, through which all of our staff who engage in oncology clinical research programs participate. 

Atlantic Research Group (ARG) Oncology Academy Logo

The Academy is a mechanism to both document the competence of each staff member and to provide ongoing training and professional development as advancements in the cancer research community emerge. We also use the Academy to share exciting advancements in the field of oncology research and treatments.

Areas of focus in the ARG Oncology Academy include but are not limited to:

  • Ongoing GCP training and regulatory updates
  • Review development of new oncolytic technologies
  • Keep apprised of updates and optimization of oncology clinical trial monitoring methods
  • Review disease-specific information as it relates to the patient and clinical sites
  • Assess current oncology clinical trial landscape for specific patient populations and indications
  • Analyze technology related to diagnosis, treatment and monitoring clinical outcomes
  • Conduct oncology-specific training, including standard of care, relevant treatment modalities and RECIST Training
  • Optimize the use of centralized monitoring to identify early safety signals that are specific for the indication under treatment and/or the mechanism of action of the investigational oncology agent
  • Update staff on oncology scientific and clinical breakthroughs
  • Reviewing and updating staff on new data management technologies
  • Mentoring with experienced oncology project managers

Oncology Case Study

ARG Rescues Phase I Clinical Trial

Challenge: Phase I Oncology Clinical Trial Data Management Issues

A leading specialty pharmaceutical company focused on drug development and commercialization of next-generation therapies for cancer and immunomodulatory diseases was mired in an unsatisfactory engagement with an offshore CRO for a Phase I oncology trial. Clinical data was delayed weeks in the cleansing and verification stages of the process. The missing pages report was inconsistent, outdated, and included incorrect data.

Solution: Team Experience in Data Science Best Practices

ARG performed a one-time data dump from the existing CTMS, analyzed the data and worked on-site to prompt corrections to the existing EDC system. The sponsor was extremely pleased with their access to real-time data from TrialVista® CTMS, and with the extremely detail-oriented and successful CRA work that Atlantic Research Group performed to rescue the study and to fix data and procedural problems created by the former CRO.

ARG employs a proprietary, analysis-based surveillance methodology that was developed to identify and minimize potential risks, proactively.

The fundamental concepts behind DDTM are Quality by Design (QbD) and Centralized Data Surveillance (CDS). Through these concepts, DDTM is supporting cross-functional collaboration between functional groups and making proactive adjustments needed for better project success. Through this process, ARG considers and addresses any difficulties in trial design sooner rather than waiting for the final data analysis. QbD focuses on identifying, defining, and collecting critical safety and efficacy endpoints and ensures that the trial design supports those patient safety and data quality for streamlined adoption of CDS.

CDS is an adaptive, targeted approach to clinical trial management. Its purpose is to direct resource allocation and activities in all functional groups, especially the monitor or CRA’s focus to the areas that have the most impact on subject safety and data quality.

Moving Forward: Clinical Trial Consistency and Leadership

The ability to consistently hit milestones while simultaneously ensuring quality is a differentiating ARG characteristic. Following ARG’s exceptional performance in the Phase I trial, we became the sponsor’s preferred provider for CRO services in early phase oncology.

ARG Best Practices and Leadership in Oncology Trials

Focus on Details

  • Leverages an ever-expanding network of relationships in worldwide clinical trials
  • Demonstrates the capacity to be effective when no blueprint exists in drug discovery
  • Adapts to complex oncology trials

Engagement with Partners

  • Allows us to notice details that drive solutions to trial challenges
  • Drives meaningful communication with stakeholders due to oncology experience
  • Fosters collaboration and innovation with experts in oncology research

Transparency For Partners

  • Provides lines of sight into budgets for cost and time predictability models
  • Fosters feedback from stakeholders for constant trial improvement
  • Adds value via communication to address challenges in rare disease cancer studies

Oncology Clinical Trial Therapeutic Specializations

ARG, as a contract research organization with global reach, long-standing relationships, and deep clinical trial experience, can provide solutions for the following specialization areas, including strategic consulting as well as oncology CRO services.

Oncology Specializations
Acute Myeloid Leukemia
Advanced Solid Tumors
Advanced Systemic Mastocytosis
ALK+ Advanced Non-Small Cell Lung Cancer
Bladder Cancer
Bone Metastasis
Brain Tumors
Breast Cancer
Chronic Iron Overload
Chronic Myeloid Leukemia
Colon Cancer
Colorectal Cancer
Cushing’s Disease
Ewing Sarcoma
Gastrointestinal Stromal Tumors
Germ Cell Tumors
Hematological Cancer
Hodgkin Lymphoma
Immune Thrombocytopenia (ITP)
Lung Cancer
Metastatic Melanoma
Mouth/throat Cancer
Multiple Myeloma
Myelodysplastic Syndrome
Neuroendocrine Tumors
Non-Hodgkin Lymphoma
Osteogenic Sarcoma
Ovarian Cancer
Pancreatic Cancer
Polycythemia Vera
Prostate Cancer
Renal Angiomyolipomas
Renal Cancer
Renal Cell Carcinoma
SEGA Tumors
Soft Tissue Sarcoma
Stomach Cancer
Temporal Cancer
Testicular Cancer
Thyroid Cancer
Waldenstrom Macroglobulinemia
Wilms Tumor