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Life Sciences

Quadrex offers comprehensive medical and scientific outsourcing solutions through diverse suppliers with proven performance. We can supply full service clinical trials, functional outsourcing, and consulting services across all therapeutic areas and phases of development. Our diverse partners have proven world class capabilities to support private industry and various U.S. Government agencies such as USAID, DOD, VA, and CDC.
Quadrex Solutions can offer sponsors flexible models for resourcing including managed employees, sponsor managed employees, and employee placement in over 40 countries allowing options to maximize efficiencies and retain high quality experienced staff for any size project.
Life Sciences
Clinical Research Services
Clinical Research Services
  • Monitoring (Blinded, Unblinded, Re-Monitoring)
  • Site Evaluation and Initiation
  • Patient Enrollment
  • Project Management
  • Contract Negotiation and Administration
  • Feasibility Studies
  • Investigator Identification
  • Rescue Studies
  • Training
  • Translations
  • Staffing
Regulatory
Regulatory
  • Clinical Trial Activations and Maintenance
  • Ethic Committee (EC)/Investigational Review Board (IRB) Submission
  • Marketing Applications
  • International Product Registration
  • Pre-IND Meeting
  • IND/IMPD consulting and submission
  • Import/Export License and IMP Release
  • Pre-NDA Meeting
  • Fast track and Orphan Applications
  • Protocol and Investigator Brochure Review
  • Review Statistical Analysis Plans, CMC, nonclinical and clinical study reports
Data Management
Data Management
  • Electronic Case Report Form Design
  • Database Development in CDISC, SDTM, and ADaM Datasets
  • Adaptive, Sequential, and Bayesian Designs
  • SAS Programming
  • Medical Coding in MedDRA and WHO Drug
  • Randomization
  • Health Outcomes Research
  • Medical Writing
Pharmacovigilance & Monitoring
Pharmacovigilance & Monitoring
  • Safety Plans
  • SAE Management
  • MedWatch 3500A/CIOMS I forms
  • PSURs, PADERs, SUSARs
  • Responsible Person for EudraVigilance
  • Expedited report generation/submission to regulatory authorities
  • Postmarketing Surveillance
  • DSMB Preparation
  • Spontaneous reporting activities
  • PVG consulting
  • Streamlining and reconciling across SAE, CTMS, and clinical DB
Other Services
Other Services
  • Quality Assurance Audits
  • Protocol Development
  • Printing
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