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Synteract, Inc. (Global Headquarters)

Description: 

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

 

Services: 

Contact Information: 

Synteract, Inc. (Global Headquarters)
5759 Fleet Street, Suite 100
Carlsbad, CA, 92008, USA
Phone : 7602682152
Fax : 7609291419
Internet : www.synteract.com
Email : tvonderreith@synteract.com
Contact Person : Trisha Vonder Reith