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Imaging CRO provides study endpoints in clinical trials which assist in determining the efficacy and safety of the drug therapy being researched. These endpoints which demonstrate the efficacy of a drug or therapy are assessed in most trials over long durations increasing the study period to years in some cases such as patient survival with serious and life-threatening diseases like cancer. A GCP compliant image management platform (ERICA) supports the study to generate robust data to convince authorities and decision makers by reducing “data noise. Biomarkers or any indicators that may help in predicting the clinical benefit though they may not be a measure of the benefit itself can help in demonstrating the results at an earlier time period and reducing the length of trial and costs. These markers can be used as surrogate endpoints, which may significantly reduce the time for confirming the clinical benefits of the drug and get approval faster. Most important imaging techniques used in trials are MRI and PET. Magnetic Resonance Imaging does not involve X-rays. It is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body in both healthy and diseased conditions. Strong magnetic fields, radio waves and field gradients are used to generate images of the organs and structures inside the body. It is unsafe to do an MRI scan if the patient has medical implants or a non-removable metal inside the body. Certain atomic nuclei can absorb and emit radio frequency energy when placed in an external magnetic field. Positron Emission Tomography is a nuclear medicine functional imaging technique that is used to observe metabolic processes in the body. Pairs of gamma rays are emitted indirectly by a positron-emitting radionuclide (tracer) into the body on a biologically active molecule for detection. Then, 3-D images of the tracer concentration within the body are constructed by computer analysis. In the new generation scanners, Computed Tomography (CT) X-Ray scans are used for this reconstruction performed at the same time on the same machine. A highly specialized core and central lab services are imaging protocol development, support in defining imaging endpoints, site training, image collection and quality control, independent reader training, independent read management, statistics, analysis and reporting. A proprietary "ERICA" image database and reading system ensures efficient processes and full transparency for sponsors. All services are provided in accordance with the FDA’s draft guidance (August 2011 and March 2015) for Medical Imaging in Clinical Trials.

CLINICAL & MEDICAL IMAGING
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ERT

ICBio Clinical Research Pvt Ltd

LabConnect

MI Bioresearch

MPI Research Inc

Navitas Inc

PAREXEL International Corporation

Pharmaceutical Product Development, LLC

TFS International AB

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Molecular Imaging and Radiochemistry

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Radiochemistry and advanced preclinical and clinical imaging research services

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Subcutaneous Models

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At MI Bioresearch, we offer more than 450 syngeneic and human tumor xenograft models, including drug-resistant and specialty models, and we are continually validating new models.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

ERT

  • FDA

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ERT Imaging

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As the leading expert in holistic imaging for clinical trials and pre-market approval research, ERT Imaging helps you visualize and realize compliant, high-quality imaging results.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Orthotopic Models

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At MI Bioresearch, we work closely with you to determine the most relevant imaging modality for the question you are trying to answer.We offer highly reproducible orthotopic models for many tissue types.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Metastasis Models

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The genes and proteins involved in metastasis have long been sought after as potential therapeutic targets. Our tumor portfolio contains a number of proprietary, efficient, and reproducible metastasis models.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Disseminated Models

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We offer more than 50 diff hematologic tumor lines, of both human and murine origin. We bring over a decade of industry-leading experience and expertise in model selection, study design, study execution, image acquisition, and proprietary data analysis.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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PDX Models

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We have utilized PDX models in the brain, breast, lung, and pancreas and applied MRI, PET, CT, and fluorescence imaging, as appropriate, to validate tumor growth in the orthotopic setting and to assess select standard of care agents in vivo.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Clinical & Medical Imaging

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PPD partnered with VirtualScopics to provide an integrated and seamless clinical and medical imaging offering that spans multiple therapeutic areas and allows clients to realize time and cost efficiencies across all trials.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Medical Imaging

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PAREXEL Informatics is a global leader in helping pharmaceutical and biotech companies employ time- and budget-saving medical imaging in clinical trials.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Immuno-Oncology

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At MI Bioresearch, we offer over 30 different syngeneic tumor models, from both solid and disseminated origins, to provide you with many choices to further your immuno-oncology research and development activities.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Scientific Operations Support

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LabConnect's experts provide dedicated scientific support focused on your specific research and development program needs. LabConnect will identify experienced scientific management professionals capable of providing a broad menu of support services.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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In Vitro Services

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MI Bioresearch In Vitro Services offer a full suite of molecular and cellular biology assays to address the invaluable need for analysis of target and drug activity before, during, and after the in vivo experiment.

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Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Reconciliation of Lab, ECG, Imaging Data, etc...

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The Clinical Data Management unit efficiently manages all aspects of data handling in accordance with the protocol, the data management plan, efficient data capture, accurate data and timely completion of the clinical database.

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Medical Imaging Services

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- Service Details

Navitas provides sponsors the benefit of superior image and data quality, a high degree of flexibility and customization, and validated and audited systems and technology.

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

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Central Laboratory

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- Service Details

ICBio Central laboratory forms the core of various studies & research activities are certified by NABL. Central Laboratory provides Demographic data, Medical histories, Physical & systemic examination, ECG, Chest X-ray, Hematology, Biochemistry, Serology.

- Directory Listing

Pharma Service: Clinical Trials

Category: Core / Central Lab

Sub Category: Clinical & Medical Imaging

Imaging CRO provides study endpoints in clinical trials which assist in determining the efficacy and safety of the drug therapy being researched. These endpoints which demonstrate the efficacy of a drug or therapy are assessed in most trials over long durations increasing the study period to years in some cases such as patient survival with serious and life-threatening diseases like cancer. A GCP compliant image management platform (ERICA) supports the study to generate robust data to convince authorities and decision makers by reducing “data noise. Biomarkers or any indicators that may help in predicting the clinical benefit though they may not be a measure of the benefit itself can help in demonstrating the results at an earlier time period and reducing the length of trial and costs. These markers can be used as surrogate endpoints, which may significantly reduce the time for confirming the clinical benefits of the drug and get approval faster. Most important imaging techniques used in trials are MRI and PET. Magnetic Resonance Imaging does not involve X-rays. It is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body in both healthy and diseased conditions. Strong magnetic fields, radio waves and field gradients are used to generate images of the organs and structures inside the body. It is unsafe to do an MRI scan if the patient has medical implants or a non-removable metal inside the body. Certain atomic nuclei can absorb and emit radio frequency energy when placed in an external magnetic field. Positron Emission Tomography is a nuclear medicine functional imaging technique that is used to observe metabolic processes in the body. Pairs of gamma rays are emitted indirectly by a positron-emitting radionuclide (tracer) into the body on a biologically active molecule for detection. Then, 3-D images of the tracer concentration within the body are constructed by computer analysis. In the new generation scanners, Computed Tomography (CT) X-Ray scans are used for this reconstruction performed at the same time on the same machine. A highly specialized core and central lab services are imaging protocol development, support in defining imaging endpoints, site training, image collection and quality control, independent reader training, independent read management, statistics, analysis and reporting. A proprietary "ERICA" image database and reading system ensures efficient processes and full transparency for sponsors. All services are provided in accordance with the FDA’s draft guidance (August 2011 and March 2015) for Medical Imaging in Clinical Trials.

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