Oncology
Oncology Medical Imaging
As the oncology clinical research landscape becomes increasingly complex, quality medical imaging is even more critical to each compound’s success. As a trial sponsor, you need an imaging partner who can keep pace with the latest advances while ensuring accurate and efficient results.
Without an experienced oncology clinical trial imaging partner, your program faces a variety of risks:
Inconsistent Data Quality
Inaccurate or missing data can lead to missed insights and poor decision making
Regulatory Roadblocks
Incomplete knowledge of the regulatory landscape can slow or halt your compound’s path to approval
Complicated data collection/review
The need for multiple data entry and report platforms can slow your data review, leading to missed milestones
Hidden costs
A lack of foresight can lead to audits, backtracking, and added expenses for your trial
With 30+ years’ experience, supporting more than 1260 oncology drug studies across a wide range of indications, Bioclinica is the clear choice for an imaging partner for all phases of clinical oncology trials. We harness the power of leading experts and the most advanced imaging technology to streamline your clinical program.
- Clinical and imaging expertise: Our team has unparalleled experience in the field of oncology imaging in clinical trials.
- Management experience: Our Oncology Project Management teams leverage phase, indication and assessment criteria experience to deliver results tailored to your timelines, metrics and budgets
- Global reach: We have offices in North America, Asia, and Europe to provide support where and when your trial needs it
- Regulatory expertise: We have ushered more than 100 oncology compounds through FDA approval, and we leverage our relationships and experience to help your compound succeed
- Planning capabilities: We provide comprehensive study and protocol design consulting to provide you with a clear path to success
- Investigational site support: We offer advanced imaging capability oversight and training to help ensure standardization across sites
- Proven technological processes: We offer robust software solutions with complete image data receipt, archival, and workflow with full 21 CFR Part 11 compliance
- Full flexibility: We have the experience to quickly adapt to the needs of your trial, operationalizing new and evolving response criteria in real time, and scaling up or down based on individual needs
- Timeliness: We ensure real-time read monitoring for all projects, ensuring decisions can be made quickly and effectively
- Clear documentation: Experienced medical writing professionals drive Imaging Review Charter development, leveraging internal and external expertise
Oncology Team
Let Bioclinica’s scientific expertise advance your oncology trial:
- Determination of trial specific oncology endpoints
- Development of imaging protocols and imaging charter
- Design of independent review methodology
- Operationalization of novel response criteria
- Delivery of high-quality data by board-certified physicians
Oncology Imaging Experience
Expert Independent Review
Bioclinica’s independent reviewers have experience with the latest advancements in tumor response criteria, imaging modalities and oncology biomarkers. Bioclinica’s team of board-certified, sub-specialty trained radiologists, nuclear physicians, and medical oncologists can expeditiously analyze all images from baseline through follow-up while providing a blinded, comprehensive oncology response review.
Clinical Trials Imaging Consulting
The need to understand the benefits and pitfalls of using medical imaging as a surrogate endpoint in clinical trials. The operational aspects of Blinded Independent Central Review. The application of Response Criteria used for endpoint determination in oncology and other therapeutic areas.
Regulatory Guidance
We leverage unparalleled regulatory experience, with more than 100 FDA oncology approvals under our belts.
Learn more about how Bioclinica’s regulatory expertise can work for you.
Molecular Imaging Modalities
Advances in molecular imaging enable the measurement of functional changes in tumor microenvironments.
Bioclinica supports a full range of molecular imaging modalities used to identify, stage, and monitor various cancers:
- 18F-fluorodeoxyglucose (FDG)
- 3’-deoxy-3’-18F-fluorothymidine (FLT)
- 18F-fluoromisonidazole (FMISO)
- 18F-NaF
- 111In-octreotide
- 123I-metaiodobenzylguanidine (mIBG)
- 99m-Tc-MDP
- 68Ga PSMA PET and 68Ga-DOTATATE
Tumor Response Criteria
Our team has expertise with conventional and novel tumor response criteria which evaluate tumor burden, metabolism, proliferation, lipid turnover and hypoxia.
Bioclinica has experience with a breadth of oncologic response criteria:
- Cheson 1999/2007
- Choi
- CNS RECIST 1.1
- EORTC
- Hallek 2008/2018
- ILD Assessment
- IMWG
- Lugano
- LYRIC
- Olsen
- Owen
- PCWG2/PCWG3
- PERCIST
- RANO/iRANO
- RECIST 1.0/1.1
- RECIL
- iRECIST
- irRECIST
- irRC
- mRECIST
- itRECIST
- WHO Methodology
In addition to:
- Novel tracer diagnostics/theragnostics
- Photography Assessment
- Tumor Volume Measurements
Oncology Trial Indications
From single-indication trials to basket trials, our oncology team has the experience to support your imaging needs.
Bioclinica’s previous disease experience includes:
- Acute Lympohcytic Leukemia (ALL)
- Acute Myeloid Leukemia (AML)
- Bladder Cancer
- Brain Cancer
- Breast Cancer
- Chronic Lymphocytic Leukemia (CLL)
- Colorectal Cancer (CRC)
- Cutaneous Squamous Cell Carcinoma (cSCC)
- Endometrial Cancer
- Gastric Cancer
- GI Stromal Tumor
- Glioblastoma
- Head and Neck Cancer
- Hepatocellular Carcinoma
- Hodgkin’s Lymphoma
- Interstitial Lung Disease
- Liver Cancer
- Melanoma
- Mesothelioma
- Multiple Myeloma
- Myelofibrosis
- Non-Hodgkin’s Lymphoma (NHL)
- Non-Small Cell Lung Cancer (NSCLC)
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Renal Cell Carcinoma (RCC)
- Sarcomas
- Small Cell Lung Cancer (SCLC)
- Thyroid Cancer
- Urothelial Cancer
- Waldenstrom Macroglobulinemia
Immuno-Oncology
Recent advances in personalized medicine and immunotherapies have given rise to an increase in the conduct of immuno-oncologic drug development. Bioclinica offers in-depth understanding of established assessment criteria as well as extensive expertise in the application of several novel approaches, including iRECIST and irRECIST.
Cardio-Oncology
The association of various oncology drugs with cardiotoxic side effects necessitates that sponsors evaluate cardiac safety endpoints, often via cardiac imaging (Echo and cardiac MR), electrophysiology (ECG) and hemodynamic (BP) measures, to define the potential cardiac safety signal and benefit-risk considerations in each therapeutic agent’s development plan.
Bioclinica has extensive expertise in planning and supporting successful cardiac safety studies, facilitating risk assessment for oncology drugs early in clinical development.
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