• ERT and Bioclinica are now Clario. Find out more about our new name, and why we have come together.

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Clinical trials in oncology

As oncology clinical research becomes increasingly complex, capturing numerous endpoints efficiently and effectively is even more critical to each compound’s success. Our technical, medical and scientific teams ensure that your solution abides by the latest industry recommendations and regulatory guidance. As a trial sponsor, you need a dedicated partner who can keep pace with the latest advances in the clinical trial landscape.

With more than 30 years of experience in supporting over 1,700 oncology drug studies across a wide range of indications, our depth and breadth of knowledge makes Clario the clear choice as your imaging partner for all phases of your clinical oncology trials. We harness the power of leading experts and the most advanced imaging technology to streamline your clinical program.

Trusted experts, at each step of the journey

Collect and analyze patient data to improve trial timelines and outcomes to enable getting new treatments to patients faster

  • Scientific expertise: Our medical and scientific team provides unparalleled experience in the field of oncology imaging; leveraging phase, indication and assessment criteria knowledge.
  • Project management experience: Project Management teams excel in delivering results tailored to your study, objectives, timelines, metrics and budgets.
  • Experienced medical writing professionals: Clear documentation drives Imaging Review Charter development, leveraging internal and external expertise.
  • Regulatory expertise: More than 100 oncology compounds have been inspected and approved by the FDA and other global regulatory bodies.
  • Comprehensive data management: Provide robust data formats and efficient transfer methods that meet industry standards for studies of all complexities.
  • Proven technological processes: Software solutions with complete image data receipt, archival and workflow with full 21 CFR Part 11 compliance.
  • Global reach: With offices in North America, Asia, and Europe, we provide support where and when your trial needs it.
  • Planning capabilities: Comprehensive clinical study and protocol design consulting is available to provide you with a clear path to success.
  • Investigational site support: 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: Ability 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 study 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.

160

approvals

365k

patients

800k

sites

2k

trials

Overview

Utilizing our resources your teams can be more productive, informed, and confident in the study endpoint data. Harnessing Clario’s experience across a wide range of oncologic disease indications and imaging modalities, in combination with robust collection strategies, will enable the delivery of high-quality data for your study.

Clario’s virtual trial capabilities can also improve the oncology patient experience by reducing travel and site visit requirements. We power at-home data collection with convenient, patient-centric solutions that ensure quality, fidelity and timeliness of delivery.

Capabilities

As the drug development and therapeutic landscape evolve, Clario uses forward-thinking methodologies and advancements to address complex issues in oncologic clinical trials. The core capabilities of our Medical Imaging Team are well designed to meet these challenges. Clario has vast experience in operationalizing conventional and novel tumor response criteria utilized in oncology clinical trials.

Collaborative study design

Clario will support you in developing solutions for your specific oncology trial, delivering accurate and precise medical and operational content that aligns with the expectations of your protocol. Our Medical Imaging Team will work with you to ensure a streamlined approach from Start Up through Close Out.

Engagement

Deliver a patient-centric trial through a combination of tailored study design, personalized content and engagement features. Clario has a range of flexible eCOA solutions to suit your patient population including Bring-Your-Own-Device (BYOD), appointment notifications, medication diary reminders and face-to-face video consultations.

Reduce time spent at site

Enabling your patients to carry out as many elements of their clinical trial safely from the comfort of their own home is important. Clario has an extensive range of integrated, easy-to-use solutions that will keep your patients engaged throughout their participation.

  • ePRO’s at home in advance of a site visit
  • Consultation via telehealth video call
  • Self-administered ECG at home
  • Ambulatory blood pressure monitoring at home
  • Activity monitoring via wearables at home
  • Easy monitoring of skin cancer with eCOA Multimedia

Monitor patient safety

Clario offers early- to late-phase electrocardiogram (ECG) and ambulatory blood pressure monitoring (ABPM) services. As the most trusted name in cardiac safety, we use a centralized approach to data collection and offer regulatory consulting on strategic protocol and study design.

5 weeks to software release

Clario’s library of pre-built commonly used eCOA oncology assessments gets you from study design to software release in just 5 weeks.

Committed study management

Clario’s Project Management will partner with your team to ensure that all timelines and deliverables are met. Our dedicated Project Teams are staffed with highly experienced members that understand the complexities and nuances of study activities, allowing efficient and effective study management.

Dedicated medical & scientific affairs support

Clario’s strong medical and science team comprises various backgrounds, skill sets and expertise. This includes on-staff radiologists, oncologists, imaging scientists and physicists who integrate scientific approaches at the forefront of our model with a customer-centric approach in our products and delivery.

Comprehensive imaging platforms

Clario provides software capabilities from automated image de-identification, to image analysis platforms that are fully customizable to your study’s endpoints and objectives. Our platforms are centered around robust data capture methods that meet the regulatory compliance standards.

Reduce site burden and simplify studies

Clario’s electronic data capture removes all the complexities of paper diaries. An easy-to-use dashboard with a single login enables clinicians to view patient compliance and safety data at a glance.
Flexible device training is available for site users, backed up by 24/7 access to our support help-desk.

Measure and monitor patient safety

Collect and monitor patient safety information with our cardiac safety services. Clario offers electrocardiogram (ECG) and blood pressure services. Clario’s centralized Cardiac Safety solution helps you maximize patient recruitment in oncology trials by ensuring only the correct patients are enrolled — and that none are incorrectly excluded.

Focus areas

Experience with novel therapeutics and interventions:

  • Cytotoxics
  • Targeted Therapies/Small Molecules (TKIs)
  • Monoclonal Antibodies
  • Bispecific Antibodies
  • Antibody Drug Conjugates
  • Immuno-Oncology/Checkpoint Inhibitors
  • Cytokines/Biologics/Immune Modulators
  • Intratumoral Injections
  • Cellular Therapies
    • CAR-Ts
    • Tumor Infiltrating Lymphocytes (TILs)
  • Chemo/Radiation
  • Integrated Biomarker Responses

Our oncology experience includes support for the following indications and areas:

  • Acute Lympohcytic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • Bladder Cancer
  • Primary Brain Cancer, including low-grade and high-grade Gliomas (e.g., Glioblastoma)
  • Metastatic Cancer with Brain Metastasis
  • Biliary Carcinoma
  • Breast Cancer
  • Cervical Cancer
  • Chronic Lymphocytic Leukemia (CLL)
  • Colorectal Cancer (CRC)
  • Cutaneous Squamous Cell Carcinoma (cSCC)
  • Endometrial Cancer
  • Esophageal/GE Junction Carcinoma
  • Gastric Cancer
  • Germ Cell Carcinoma
  • GI Stromal Tumor
  • Head and Neck Cancer
  • Hepatocellular Carcinoma
  • Hodgkin’s Lymphoma
  • Liver Cancer
  • Melanoma
  • Mesothelioma
  • Multiple Myeloma
  • Myelofibrosis
  • Neuroblastoma
  • Neuro-endocrine tumors/Carcinoid
  • Non-Hodgkin’s Lymphomas (NHL)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Ovarian/Primary peritoneal Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Renal Cell Carcinoma (RCC)
  • Sarcomas
  • Small Cell Lung Cancer (SCLC)
  • Thyroid Cancer
  • Urothelial Cancer
  • Uterine Cancer
  • Waldenstrom Macroglobulinemia

Common adverse events associated with cancer treatments:

  • Target therapies (TKIs), Immuno-oncology and Cellular therapies:
    • ILD/PneumonitisColitis
    • Cytokine Storm
    • Tumor Flares

Talk to a specialist

Our team of experts is available to address any questions you may have about our oncology solutions. Submit your contact information and we’ll be in touch shortly.