CCBR - Synarc
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CCBR - Synarc
David Herron, Vice President, Sales & Marketing
575 Market Street, 17th Floor
San Francisco, CA 94105 USA
Phone: 415- 817-8962
Fax: 415- 817-8960
E-mail:
Web: http://www.synarc.com
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Synarc Overview
Synarc’s mission is to bring better therapies into clinical use
faster. Synarc's radiologists and scientists are leading
authorities in the use of medical imaging and biochemical markers
in drug development, and have pioneered many methods currently used
in clinical trials. In addition, our services include Clinical
Research Centers. Synarc’s eleven Clinical Research Centers conduct
global clinical-development and basic-research. We specialize in
rapid subject recruitment with minimal dropout rates.
Synarc has eighteen offices around the world and currently
manages over 230 clinical trials involving more than 200,000
patients. Our services integrate all aspects of the design and
execution of early to late phase clinical studies, including the
centralized analysis of both standard and esoteric medical imaging
and biochemical markers.
Based on our decades of combined experience in handling
multi-center clinical trials, we have developed a robust approach
to overcome challenges and meet our client’s study objectives.
Synarc offers a rich array of integrated services which support all
aspects of designing and executing the imaging component of a
clinical trial. These services include:
- Design and review of clinical protocols
- Development of imaging charters to support clinical
protocols
- Multiple options for site training and qualification
- Web-based portal to support data submission, sharing of study
documents and appropriate reports
- Imaging and logistics support for sites
- Imaging site recommendations and selection
- Digital Data Translation and Film Digitization
- Review of study image acquisition for conformance to imaging
charter and study protocol
- Quality assurance of imaging acquisition including prompt
feedback to site
- Centralized image analysis, including quality control by
in-house radiologists
- Support for multiple imaging modalities (MRI (at multiple field
strengths), X-ray, PET-CT, DXA, CT, photography, Scintigraphy,
Ultrasound, Bonescans, SPECT) including submission of
high-resolution data
- Support of data submitted on digital media and film
- 21 CFR Part 11 compliant quantitative and semi quantitative
scoring systems
- Eligibility confirmation
- Systems support multiple readings with adjudication
- Systems support remote and global readings
- Safety reading and management
- Ability to support modification of standard reading criteria
(e.g. Genant-Sharp, CHESON etc.)
- Image and data transfers optimized to meet sponsor
needs
- Regulatory submission support including preparation of 21 CFR
Part 11 compliant imaging system
- Dedicated and experienced project team to address sponsor and
study specific needs
Medical and Scientific Expertise
At Synarc, we have brought together the world's leading
authorities in this unique application of radiology, biochemical
markers and subject recruitment to create a truly unprecedented
type of service for global drug development. Working together, we
can select and implement the right endpoints, imaging sites, and
analytical methods to suit your particular needs and
circumstances.
Synarc's scientists and radiologists are the leading
authorities in the use of medical imaging, biochemical markers in
drug development, and have helped develop many methods currently
used in clinical trials. They are knowledgeable in all existing
regulations that apply to imaging, biochemical markers and subject
recruitment in clinical trials but also new legislation on the
horizon, and understand the implications to your program. Designing
a program correctly the first time saves time and money down the
road.
Facility Description
Medical Specialty Areas
We have partnered with global industry leaders across a wide
range of therapeutic areas to bring over 20 new compounds to
market. We currently manage over 230 multi-center clinical trials
with over 200,000 patients through eighteen offices around the
world. We have experience in:
Therapeutic Areas Served:
- Cardiology and neurovascular diseases
- Neurology
- Oncology
- Orthopedics
- Osteoarthritis
- Osteoporosis
- Rheumatoid arthritis
Modalities Offered
At Synarc, we will work with you to provide with the modality
that best fit your clinical trials program. We offer
multi-modalities services to include Radiography, CT, MRI,
Ultrasound, DXA, scintigraphy, SPECT, and PET, and assays for
specialized biochemical markers.
CCBR - Synarc
David Herron, Vice President, Sales & Marketing
575 Market Street, 17th Floor
San Francisco, CA 94105 USA
Phone: 415- 817-8962
Fax: 415- 817-8960
E-mail:
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