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Synteract Inc

Description: 

 

 SynteractHCR is a full-service multinational clinical research organization with more than two decades of experience supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development and across multiple therapeutic areas. We have a unique understanding of the financial and time challenges faced by mid-sized and large companies in day to day business operations, and have developed the systems and processes to guide them in discovery and development. With our “Shared Work – Shared Vision” philosophy, we provide customized services collaboratively and cost effectively to ensure on time delivery of quality data so clients can get to decision points faster. Operating in 16 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

Full service clinical operations include: project management, clinical trial design, clinical trial monitoring/site management, data management, biostatistics, regulatory affairs, and medical writing. Our global staff manages trials internationally and offers expertise across a wide range of therapeutic areas including a notable depth in oncology, CNS, cardiovascular, respiratory and ophthalmology.

 

Exceptional Services Customized to Meet Your Specific Needs

Clinical Study Management

• Program/study planning & management

• Study start up

• Regulatory document management

• Site monitoring and management

Biostatistics

• Study design

• Statistical analysis plans

• Table/listing/figure programming

• Data analysis

• DMC establishment/coordination

• CDISC

• ISS/ISE

Remote Internet Access

• Data browse and query (Integrated Review™)

• Study status reports, CRF/Query viewing

• Serious adverse events reporting

Central Randomization

• Interactive Response Technologies

• Randomization (schedule or dynamic)

• Drug inventory control

• Patient diaries

Data Management

• SynCapture™ (EDC)

• Clinical DataFax™ (Fax or DDE)

• Medidata Rave®

• Third party EDC products

Medical/Safety/Regulatory

• Strategic planning

• Regulatory project management and submissions

• Medical monitoring

• Oracle® Argus (database hosting & safety services)

• Pharmacovigilance

• E2B gateway

Medical Coding

• MedDRA ™ WHO DRUG coding

• SynCoder™ AutoCoder/online coder

 

Contributor to Many FDA Approvals and Rescue Studies Specialist

SynteractHCR has managed more than 3500 projects, contributing to more than 200 product approvals. Over our history, we have saved many studies; in fact, we rescued 40 studies since 2009 alone. Our low turnover in personnel and high experience levels mean you work with specialized teams familiar with our processes, and aware of our dedication to quality and responsiveness.

More than 90% of our business comes to us from repeat business and direct referrals from customers because of our customer focused philosophy and support.

 

Business Development Inquiries and RFP Contact

Headquarters: Matt Smith, SVP Business Development, US matt.smith@synteracthcr.com, +1 760 268 8200 

 

 

 

Services: 

Cardiovascular Monitoring/Pulmonary Diagnostics, Clinical Trial Design, Clinical Trial Monitoring, Data Management, Medical Writing, Project Management, Randomization (Automated/Centralized/Vocal Computer), Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation, Statistical Services/Meta Analysis

Contact Information: 

Synteract Inc
5759 Fleet Street, Suite 100
Carlsbad, CA, 92008, USA
Phone : 7602682152
Fax : 7609291419
Internet : www.synteracthcr.com
Email : trisha.vonderreith@synteracthcr.com
Contact Person : Trisha Vonder Reith