WarrickUSA LLC

GCP Personified

WarrickUSA, LLC provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. Our services include clinical research, clinical trials management, pharmacovigilance and biopharmaceutical development. We also offer support of research institutions, foundations, universities, and governmental organizations (such as the NIH, EMEA, etc.). WarrickUSA, LLC specifically provides clinical-study and clinical-trial support for new drugs, therapeutics, biologics, and medical devices. We specialize in assisting sponsor companies through the clinical development lifecycle from its conception or discovery until the FDA/EMA marketing approval.

We at WarrickUSA recognize the importance of an efficiently managed clinical trial in accordance with current ICH-GCP guidelines, without the complexities and delays common with larger CROs. With over 30 years of experience, we understand the need for quality throughout the duration of your clinical program and will implement industry best practices to avert costly delays. WarrickUSA recognizes that your success depends on the performance of the professionals who represent you. Our no-compromise promise of quality and ethical principles is the foundation of Warrick USA. With a proven track record in achieving the succesful filing of multiple NDAs and BLAs, let the strength of our experience be yours, too.

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High Quality Services Offered

  • Study Start-up Activities:  assist with the development, distribution, and retrieval of feasibility questionnaires; identify study sites and conduct pre-study assessment visits; collect and track regulatory documents; populate and distribute site regulatory binders; study contract and patient budget negotiations.    
  • Monitoring and Co-Monitoring Assistance:  conduct site initiation, interim, and close-out visits; provide co-monitoring assistance; provide un-blinded investigational product monitors.
  • Forms Development:  assist with the creation of all study-related forms including source document worksheets, Case Record Forms and instructions, investigational product tracking forms, and monitoring forms.
  • Document Review:  proof and edit regulatory submissions as well as all study related documents to ensure consistency within and between the documents; review tables, listings, and graphs. 
  • QA and Auditing:  conduct QA audits--GLP and GCP; review of investigational site and sponsor central files. 
  • E-Mail Efficiency:  print, organize, and distribute copies of relevant e-mail correspondence between the sponsor/monitors and investigational sites throughout the study for the Trial Master File; provide a listing of all e-mail correspondence at study completion; provide training to sponsor/monitors and investigational sites regarding E-Mail Efficiency
  • IND Safety Report Notification and Tracking:  copy, distribute, and track IND safety letters, SUSARs, and CIOMS reports to investigators; provide listing of reports to sponsors/monitors and investigational sites.
  • Transitional Training:  provide training for private practice physicians to incorporate clinical research into their practices.