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The Recognized World Leader in Diagnostic Imaging Agent Development |
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Contrast Imaging 'agents' are used to get more clinical information for diagnosis, staging therapy and treatment from images. With technological advances in imaging modalities and Nuclear Medicine, imaging is now possible at the molecular level providing deep insight into progression of disease and efficacy of drugs. We are recognized as the leading CRO in this specialized area.
We have contributed to
“Marketing approval by US FDA & EMA of Piramal Imaging’s ‘NeuraCeq’ for PET Imaging of Neuritic Beta-Amyloid Plaques, in the Brain of patients being evaluated for Alzheimer’s disease” Approval was based on an intercontinental study of patients with a high probability of beta-amyloid deposition where the primary end point was pathology of the brain donated after death. In this highly challenging study, sites in Australia, Japan and Europe were audited by EMA and FDA for GCP compliance.
Marketing approval was granted by the US FDA for a gadolinium contrast agent in breast MR imaging, the first contrast agent approved for this indication in the US.
Contrast imaging agent clinical trials expert- We have contributed to the development of several contrast agents. Phase Zero study using micro dosing, First in Man study, early stage studies, to large intercontinental Ph III pivotal studies have been conducted by us.
We have successfully completed as CRO the largest number of contrast agent studies. We have enrolled nearly 6000 patients in these studies in five continents. We have experience in complex paediatric imaging studies. |
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Experience by Modality
- PET, Nuclear SPECT
- MRI, CT, X-ray, Mammography
- Cardiac imaging, interventional Catheterization-lab
- Ultrasound
Experience by Therapeutics Area
- CAD, PAD, Arterial Occlusive disease, Hypo-perfusion, Aortialic disease
- Cancer (Breast, CRC, Prostate, Brain, Head & Neck etc.)
- Focal Liver lesion
- TBI, Alzheimer's, Parkinson's
- Diabetes, Renal impairment, NSF
- Hip/Knee replacement
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Expertise
- Blinded reading, NCI tumour measurement techniques
- Regulation of Atomic Energy Boards
- Marketing authorization in all six continents
Consulting Experience
In a post Authorization Safety study for EMA/FDA, we are playing the role of sponsor for 7 marketing authorization holders. We are conducting as CRO a complex intercontinental study.
We have been consulted in market access strategy, partnering strategy, funding application apart for developing regulatory pathway and clinical trial design and development plan. |
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