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Oncology

Advanced Oncology Medical Imaging

We have the deep experience you need Bioclinica has the medical imaging solutions you need and the deep scientific, regulatory, and medical expertise to adeptly support your oncology clinical trials. Bioclinica has experience with supporting trials on some of the biggest drugs and biggest pharmaceutical companies. Yet we have the flexibility to scale up or down, no matter your size.

With over 1100+ oncology drug studies conducted across a wide range of oncology indications, Bioclinica has the expertise and experience with all trial phases and can provide support from the start of your oncology trial (protocol design and imaging charter development) all the way through to regulatory submission and archiving of image data — with a full 21 CFR Part 11 compliant process.

Oncology Leadership

  •   30+ Years of Experience

  •   Nearly 60: FDA-approved oncology drugs

  •   Over 1100 oncology studies across a wide range of indications

Bioclinica has extensive experience applying oncology imaging for:

Eligibility

inclusion or exclusion of study patients

Safety

(evaluating safety profiles)
components of clinical trials

Bioclinica's oncology services include:

  •   The latest developments in imaging endpoints

  •   Qualitative and quantitative image analysis for all available imaging modalities

  •   Full 21 CFR Part 11 compliance

  •   Protocols to maintain contact with the FDA to implement regulatory guidance

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

  •   Delivery of high quality data by Board-certified Physicians

Oncology Trial Indication Experience

  • Head and Neck Cancer

  • Liver Cancer

  • Lung Cancer

  • Lymphoma

  • Melanoma

  • Mesothelioma

  • Multiple Myeloma

  • Brain Cancer

  • Breast Cancer

  • Carcinoid Ascites

  • Chronic Myeloid Leukemia

  • Colorectal Cancer

  • Gastric Cancer

  • GI Stromal Tumor

  • Ovarian Cancer

  • Pancreatic Cancer

  • Prostate Cancer

  • Renal Cell Carcinoma

  • Sarcomas

  • Transition Cell Carcinoma of Urothelium

  • Thyroid Cancer

 

Immuno-Oncology

Recent advances in Personalized Medicines and Immunotherapies have given rise to an increase in the conduct of immuno-oncologic drug development. Bioclinica offers detailed understanding of established assessment criteria as well as extensive expertise in the application of modified RECIST or irRECIST criteria.

Cardio-Oncology

The association of many oncology drugs with cardiotoxic side effects necessitates sponsor vigilance and independent cardiac safety studies. Bioclinica has extensive expertise in planning and supporting successful cardiac safety studies facilitating risk assessment for oncology drugs early in clinical development.

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support your next trial.

CONTACT US Overview Sheet

Bioclinica's application of SMART in Oncology

Bioclinica advances clinical trials via SMART — a robust suite of centralized medical imaging services designed to manage the complex imaging process from image receipt to analysis, to regulatory submission.

Modality Expertise

With 30+ years of leading imaging expertise, Bioclinica is adept at all normal and novel imaging modalities for Oncology trials, including:

  • CT
  • MRI
  • X-ray
  • DCE-MRI
  • FDG and FLT-PET
  • PET-CT
  • Laparoscopic video
  • Photography
  • Bone scan

Molecular Imaging Expertise

Advances in molecular imaging enable precise measurements of molecular targets and biochemical changes in tumors. 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)
  • 111In-octreotide
  • 123I-metaiodobenzylguanidine (mIBG)
  • Technetium-99m

Once available, images are electronically uploaded from trial sites, blinded and rigorously quality checked. Bioclinica employs a “Multi-Step Quality Control” process that ensures the image data received from the sites will be of the highest quality. Our process enables thorough and precise image data management and analysis. We accept DICOM or manufacturer-specific formats.

We track all patients enrolled in studies and all imaging data generated during the course of a clinical trial. Our expert technicians use innovative tools to deeply review, update, and assure compliance with clinical trial protocols and defined reading paradigms. This enables queries to be issued, tracked, and resolved. Our ICL collection management process is designed to detect early on any substandard image quality or violations of the imaging protocol.

Our imaging core lab collection management process includes:

  • Collect image data
  • Query sites for missing data
  • Translate/digitize image data
  • Image QA/QC
  • Image data query resolution
  • Archive for long-term storage
  • And more

Expert Independent Review

Bioclinica's independent reviewers have experience with the latest advancements in tumor response criteria, imaging modalities and oncology biomarkers, ensuring an innovative solution and world class resources in support of oncology clinical trials with imaging endpoints. Bioclinica's team of board-certified, sub-specialty trained radiologists, nuclear physicians, and medical oncologists analyze all images from baseline to completion with fast turnaround times and can provide a blinded, in-depth oncology response review.

  • Sophisticated algorithms for semi-automatic, bi-dimensional, and volumetric tumor measurements
  • Custom-designed lesion tracking for longitudinal studies
  • Real time derivation for accelerated calculations and reduced error
  • Automatic transfer of image analysis data into eCRFs

Network of Key Opinion Leaders (KOL)

As an industry leader in imaging core lab services, Bioclinica has long-standing relationships with a vast network of academic and research key opinion leaders (KOLs) who are available for image review, quality assessment, and imaging charter support. Our KOLs are well recognized for their oncology expertise and provide an additional resource for sponsors planning oncology trials.

Bioclinica has a team of oncology experts and leaders in the field

John Michael O'Neal MD
Dr. O'Neal provides leadership and oversight to Bioclinica's staff radiologists and external radiology consultants. Chief Medical Officer and Head of Oncology, he provides extensive knowledge and oncology experience to the design and implementation of your trial.

Click the names below to learn more about our team of experts.

Oncology Imaging Endpoint Analysis

Imaging endpoints play a central role in oncology trials — determining patient enrollment, prognosis, diagnosis, surveillance, safety, and clinical outcome. Depending on the modality and cancer type, there are many imaging endpoints involving the assessment of tumor responses. These include disease-free survival, objective response rate, time to progression, progression-free survival, and time to treatment failure.

Correct lesion identification and tracking is vital to ensure accurate and precise interpretation during oncology clinical trials. The analysis of oncology imaging endpoints may utilize a number of response criteria, including:

  • Cheson

  • Choi

  • EBMT

  • EORTC

  • Hallek

  • IHP

  • Lugano (Cheson et al., 2014)

  • Macdonald

  • PCWG2

  • PERCIST

  • RANO

  • RECIST 1.0/1.1

  • Volumetric Assessment

  • WHO Methodology

  • Wolchock Immune Related Response Criteria

Bioclinica's oncology team has experience with all of these criteria and routinely supports studies using multiple modalities and endpoint analyses.

With Bioclinica, you’ll receive powerful, comprehensive reporting services for sites and sponsors, which supports the management and review of data for clinical trials.

Gain access to real-time reports, such as:

  • Metrics reports

  • Project status reports

  • Custom client reports

  • Analysis results reports

  • Safety and eligibility reports

  • Billing reports

Bioclinica's transfer tools support a wide range of formats to meet client and project specifications — tools that enable clinical trial data delivery, including patient data and imaging data, to sponsors, external vendors, and partners.

LEARN MORE ABOUT THE SMART PROCESS

DOWNLOAD INFOGRAPHIC

ADDITIONAL RESOURCES

Medical Imaging Services for Clinical Trials

Download Brochure

Oncology Medical Imaging Expertise Sheet

Download OVERVIEW SHEET

On Demand Webinar: Critical Regulatory Considerations for Imaging Trials: What You Need to Know

Watch On Demand Webinar

Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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