Theradex

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Theradex® is an international contract research organization providing complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases. Theradex® conducts studies which lead to marketing approval of significant medical advances; and has built a reputation on assuring the scientific objectivity and meticulous quality control that fulfills all regulatory requirements. Our expertise is also available to assist client personnel in expedited development planning and execution.

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Type Privately Held
Number of employees 51-200 employees

Services

Document Development and Management

  • Data Management Plans (DMP)
  • eCRF Completion Guidelines (eCCGs)
  • EDC Design Specifications
  • Edit Check Specifications
  • Data Transfer Specifications
  • System Validation Specifications
  • Standards and Custom Listing Specifications

Electronic Data Capture Study Builds

  • eCRF Design
  • EDC Development and Validation
  • Edit Check Programming and Validation
  • Reporting Tool Configuration

Data Project Management

  • Data Cleaning
  • Medical Review
  • Quality Control Review
  • Medical Coding
  • SAE Reconciliation
  • Vendor Reconciliation

History

Theradex was founded in 1982 with the award of the Clinical Trials Monitoring Service contract for the National Cancer Institute (NCI) in the United States. The Clinical Trial Monitoring Service provides central data management and monitoring services for early phase cancer trials sponsored by the NCI. In 2014, the services expanded to support trials conducted under the NCI Experimental Therapeutics Clinical Trials Network (ETCTN). Theradex’s support of NCI programs also includes audits of NCI-supported cancer center programs participating in NCI sponsored clinical trials.

Theradex’s early collaboration with NCI led to an expansion of services to pharmaceutical industry sponsored oncology clinical trials. Theradex has always recognized that each sponsor requires a personalized approach to meet their drug development and business needs. This commitment to service has supported Theradex’s growth which has been primarily driven by referrals. The continued focus on personalized service has been Theradex’s approach to business development.

With the expansion of services to support our varied client base, the Theradex (Europe) Ltd office opened in 1992 enabling the company to expand services to Europe. Since 1992 Theradex has provided global services through partner relationships in other geographic regions including Asia.

Theradex has continued to expand our capabilities by introducing efficiencies to the clinical trial process through integrated systems and expanding our expertise as personalized medicine becomes a reality.

Theradex history has spanned over three decades from the early days of clinical trials with limited advances in oncology to the more rapid advances of today where pathways and patient genetic profiles are driving a targeted approach to treatment and research efforts.

Our strong interest in the science of new therapeutic approaches has led Theradex to evolve with the advancements in cancer treatment. Theradex remains committed to the science of cancer research and our clients who continue to drive the advances in treatment options for cancer patients.

Controversies

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October 09, 2020johnfai79616187Pelosi states UK’s efforts to create a vaccine not on a par with United States , with FDA’s “very stringent” rules… https://t.co/eA8Sx5VnaE


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