Monday, July 28, 2014  
 
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Theradex
Theradex
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Services
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Clinical Development
Study Startup
Clinical Monitoring
Data Management
Analysis
Global Safety
Medical Writing
Clinical Supply Distribution
Other Study Services

Our Contact Information

Mailing ::
Theradex®
CN 5257
Princeton, NJ 08543

Courier ::
Theradex®
4365 Route 1 South
Princeton, NJ 08540

Click for Directions
Phone 609.799.7580
Fax 609.799.4148
Email: info@theradex.com

Clinical Development Services
  • Clinical Development Strategy Consulting
  • Regulatory Strategy Consulting
  • Pre-clinical Toxicology and Pharmacology Review
  • Preparation of non-U.S. Regulatory Filing to National Health Authorities
  • Preparation of IND Filings
  • Negotiation of Resolution of FDA Questions
  • Develop Assessment Techniques for Drug and Diagnostic/Prognostic Antibody Tests
Study Startup Services
  • Investigator / Site Selection
  • Case Report Form Design
  • Protocol Writing
  • Study Manual Design
  • Regulatory Document Collection
Clinical Monitoring Services
  • Clinical Monitoring by Staff Specially Trained in Oncology Clinical Trial Monitoring
  • Performance of GCP Compliance Audits
  • Clinical Trials Integrity Auditing
  • Selection and Administration of Quality of Life and Pharmacoeconomic Instruments
Analysis Services Global Safety Services
  • Global Safety Reporting and Medical Review
  • Preparation of SAE Narratives and Summaries
  • Support and Coordination of Data Safety Monitoring Boards (DSMB)
Medical Writing Services
  • Preparation of Annual and Final Clinical Study Reports
  • Preparation of Abstracts and Manuscripts
Clinical Supply Distribution Services
  • Investigational Drug Storage and Distribution
Other Study Coordination Services
  • Coordination and Presentation at Investigator Meetings
  • Randomization Services via Interactive Voice Response System (IVRS), Therand®
  • Secure Limited Access Status Reporting via TheraGuard®
To accommodate your individual needs, Please contact us for further details and related information.
Experience

Theradex® has over 27 years of oncology clinical trials experience with an emphasis on Phase I studies. Since our founding in 1982, we have monitored and held the data for all US National Cancer Institute Phase I trials.

Theradex® has supported both broad and target Phase II programs for our clients. From single center two-stage design to multinational randomized Phase II programs. Theradex has the in-house expertise to support your research program.

Theradex® has successfully managed international Phase III programs supporting the development of cytotoxics, biologics and molecular targeted therapies.