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Waterborne’s Ecotoxicology Team Redefines the Definition of “Study Management” Services

April 17, 2015


Many consulting organizations specializing in ecotoxicology offer their clients study monitoring services. Waterborne’s Ecotoxicology Team has worked to further define our “study management” offering to better capture the comprehensive value of the service. Although our staff is highly experienced in the process and nuances of monitoring laboratory and field studies, we feel our true value to our clients lies in our insight beyond the endpoint – high-level, experienced-based consulting which can have a profound positive impact on a project from beginning to end.

OUR EXPERT APPROACH TO STUDY MANAGEMENT

We use our insight beyond the endpoint to define our study management practices and we consult with our clients on study plan requirements or specific ecological effects questions. Our team is equipped with the understanding of study design, potential challenges and risk assessment requirements to meet your assessment needs. This allows us to recommend applicable standard guideline studies, design complex and customized studies, advise on additional studies that may be triggered or studies that may be waiver candidates, and use current state-of-the-science to make study assessments. We also understand the importance of taking physical chemical and environmental fate properties and exposure data into consideration within the context of a risk assessment. Based on our data assessment and our understanding of current approaches, we can formally defend or dispute existing studies and develop study waivers for regulatory submission. Our goal is to incorporate this high-level regulatory strategy into all phases of
study management.

HOW WE HELP OUR CLIENTS

Once the initial decisions are made and studies are conducted, an expert assessment of the study data and review of any potential study concerns is essential. A seemingly minor study concern may result in a regulatory rejection and, conversely, an apparently major study concern may have a valid justification for regulatory acceptance and use in a risk assessment. When a study concern arises, the resolution may involve any of the following: a detailed justification, investigation into historical data, reanalysis, refined statistical methodology, repeating a portion of the study or repeating the full study. Our Ecotoxicology Team is able to expertly assess study data, recommend a course of action and follow through.

HOW WE CAN HELP YOU

We pride ourselves on the value we add to the management of a study or a program. We invite you to view our comprehensive list of study management services >>

 

Meet our Study Management Team:

Matt Kern, Principal Scientist, Environmental Risk Assessment
• Ecotoxicologist with 18 years of industry experience, including direct laboratory management
• Specializes in environmental risk assessment, endangered species assessment and consulting on regulatory strategy

Gregg Hancock, Lead Scientist, Environmental Risk Assessment
• Ecotoxicologist with 20 years of industry experience, including direct laboratory management
• Provides versatility through a well-rounded technical expertise and experience with various industry and regulatory needs. Specializes in environmental risk assessment and regulatory strategy

Duane Huggett, Lead Scientist, Toxicology and Risk Assessment
• Environmental toxicologist with over 13 years of industrial, academic and regulatory science experience
• Expertise in laboratory design and management of complex in vivo and in vitro environmental toxicity studies, study monitoring of environmental and non-clinical mammalian studies, environmental risk assessment, and product defense

Mark Cafarella, Senior Scientist, Ecotoxicology
• Ecotoxicologist with 21 years of leadership experience in a contract research laboratory, including Director of Ecotoxicology for North American and European offices
• Expertise in study design, technical study conduct and regulatory guidelines for aquatic, sediment and terrestrial ecotoxicology

Jennifer Gates, Scientist, Ecotoxicology
• Over 7 years of experience in resource and project management in a contract research laboratory and over 10 years of technical writing experience
• Knowledgeable in regulatory guidelines and study conduct for over 100 different study types in ecotoxicology, environmental fate and metabolism, and chemistry
We are happy to discuss how our study management capabilities may be customized to meet the needs of your business, so please contact us for more information.