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ServiceStudy Management – Ecotoxicology and Environmental Fate

Overview

Our ecotoxicology team has a number of individuals who have actually served as study directors in the lab for most of the studies we manage.  We come from contract research, university and industry laboratories.  This experience offers a unique pedigree in the consulting world and allows Waterborne to bridge the gap between study conduct and risk assessment from a unique perspective.  We consider this a key value proposition to our clients.  Additionally, members of the ecotoxicology team are strategically located in close proximity to some of the major contract research laboratories in the US.  This proximity allows the opportunity for face-to-face meetings, as needed throughout the project, without the need for extensive travel time or associated expenses.

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Our Services

Waterborne offers services which include the monitoring of studies (ecotoxicology and environmental fate and metabolism) from design and protocol generation to final report.  Additionally, Waterborne offers comprehensive project management for an entire data package.  These comprehensive services include:

  • Consultation on study plan requirements, as well additional studies that may potentially be triggered
  • Overall project management cost
  • Collaboration with the client for the defense of existing studies and the development of study waivers.
  • Solicitation and review of bids from qualified contract research laboratories
  • Recommendations for study placement based on qualifications, cost and timing
  • Management of deadlines with contract research laboratories
  • Development of higher-tiered and customized study designs
  • Review of study-related documents (e.g., study protocols and reports)
  • Consultation on studies with new species and test designs
  • Assessment of study data and potential study concerns from a regulatory perspective
  • Expertise in Good Laboratory Practices (GLP)

Related Publications:

An Evaluation of Endpoints from Benthic Invertebrate Chronic Toxicity Tests Based On Draft US FIFRA Guidance – Part II