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Therapeutic Areas

WorldCare Clinical is a leading provider of imaging services for CNS clinical trials.

Neurology indications

Our team has provided imaging CRO services on Phase I-IV drug and device trials across Neurology indications, including:
  • Alzheimer's Disease
  • Cerebral Adrenoleukodystrophy (ALD) 
  • Epilepsy/Seizures
  • Glioblastoma & Malignant Glioma
  • Multiple Sclerosis
  • Parkinson's Disease
  • Spinal Cord Injury
  • Stroke
  • Subarachnoid Hemorrhage
  • Traumatic Brain Injury
We have experience across modalities, including CT, CTV, fMRI, IVUS, MRI, Venography, PET-FDG, and SPECT.

Evaluation criteria

We have extensive experience with Neurology studies involving the following types of evaluation criteria:

-  Amyloid Burden
-  Brain atrophy
-  Brain volumes
-  Brain/Ventricle Boundary Shift Integral 
-  Caudate delineation
-  Consensus gadolinium-enhancing lesion count/volume
  -  Cortical thickness change
-  Hippocampal volume change
-  Lesion count
-  Loes score
-  PET SUVr/Visual Hybrid assessment
-  Safety
Scheltens Hippocampal Atrophy score
-  Whole brain segmentation
-  Cerebral Vasospasm Assessments
-  Cerebral Circulation Time
-  Spinal Cord Compression

Read team
Our dedicated team of radiologists, neurologists, technicians, regulatory experts, and project managers is among the most knowledgeable and well-respected in the industry. Our services also include safety monitoring.

Study design

Our experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor's clinical trial goals. 

Reader training

Through a combination of our expert radiologists and our rigorous training and testingregimen, we are committed to increasing the accuracy and precision of data subject to blinded independent central review. Sponsors have the flexibility of working with our highly-trained in-house radiologists, with sub-specialty-trained board-certified radiologists from the Harvard Hospital System, or with other radiologists of the sponsor's choice. 

Web-based technology platform

Our state-of-the-art systems are 21 CRF Part 11 compliant and are used to analyze images from all modalities. The systems can be accessed by radiologists to perform assessments anywhere in the world. Thousands of clinical sites in the U.S., Latin America, Europe, and Asia-Pacific have uploaded imaging data directly into our secure system. 

Regulatory experience

We have an extensive history in preparing submissions for regulatory approval by the U.S. Food and Drug Administration (FDA) Medical Imaging Division and the European Medicines Agency (EMA).  Our Quality Management System is designed to provide the structure and controls required to support execution of the clinical study, while ensuring that processes meet current regulatory standards. 

Learn more
You can learn more about imaging in CNS clinical trials by reviewing our publications below.  To learn more about our CNS services, please contact us at +1.888.816.4721.

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Contacts
888.816.4721 | +1.513.924.5183
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