Synteract, Inc.
Global headquarters: 5759 Fleet Street, Suite 100
Carlsbad, CA 92008, United States
Phone: +1-760-268-8200
Fax: +1-760-929-1419
Internet: www.synteract.com
Contact: Trisha Vonder Reith Email: tvonderreith@synteract.com
Services
Shared Work – Shared Vision™ is not just a tagline, but a description of the way Synteract does business, a promised standard that includes ongoing support from a specialized team dedicated to meeting or exceeding your expectations. Since 1995, Synteract has a successful track record as a full-service contract research organization (CRO) working with biotech, pharmaceutical and medical device companies in all aspects of clinical research trials, Phases I through IV. We have a unique understanding of the financial and time challenges faced by small to mid-sized biopharmaceutical companies in day to day business operations, and have developed the systems and processes to guide them in discovery and development. Synteract provides customized services collaboratively and cost effectively to ensure on-time delivery of quality data so clients can get to decision points faster.
Full-service clinical operations include: project management, clinical trial design, clinical trial monitoring/site management, data management, biostatistics, pharmacovigilance, 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 Data Management
Program/study planning & management SynCapture™ (EDC)
Study start-up Clinical DataFax™ (Fax or DDE)
Regulatory document management Clintrial™
Site monitoring and management Third-party EDC products
Biostatistics Medical/Safety/Regulatory
Study design Strategic planning
Statistical analysis plans Regulatory project management and submissions
Table/listing/figure programming Medical monitoring
Data analysis Oracle® Argus (database hosting & safety services)
DMC establishment/coordination Pharmacovigilance
CDISC E2B gateway
ISS/ISE Medical Coding
Central Randomization MedDRA™ WHO-DRUG coding
IVRS and IWRS SynCoder™ AutoCoder/online coder
Randomization (schedule or dynamic Remote Internet Access
Drug inventory control Data browse and query (Integrated Review™)
Patient diaries Study status reports, CRF/Query viewing
Serious adverse events reporting
Contributor to Many FDA Approvals and Rescue Studies Specialist
Synteract has managed more than 1400 projects, contributing to 24 product approvals. Over our history, we have saved many studies; in fact, we rescued 33 studies since 2009 alone. Our low turnover in personnel and high experience levels mean you are working with specialized teams familiar with our processes and aware of our dedication to quality and customer delivery. 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 Sales and Marketing, msmith@synteract.com, +1-760-268-8200