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The path to the clinic starts here.

Comprehensive preclinical research is the most critical element of an IND, there are no shortcuts to be taken.

We support our clients with the resources and expertise they need to design and oversee toxicology and safety pharmacology studies (in vitro and in vivo). The goal of these essential studies is to predict the safety of your drug, thus paving the way for safe dosing in humans.

We provide comprehensive preclinical support.

During the preclinical research phase, our team will help you focus on identifying both the limits of safe dosing and the specific adverse event liabilities, thus minimizing risks to clinical subjects as well as risks to your program. Moreover, we provide Single Study Support and can quickly determine if your candidate requires a quick proof-of-concept pharmacology study or a bridging toxicology study.

Regardless of what your clinical candidate needs, we will assemble the senior preclinical experts and project management support to:

  • Develop a global preclinical plan
  • Implement a strategy to support the clinical development plan
  • Design the most effective studies
  • Find and audit vendors needed to conduct the studies
  • Develop all necessary protocols
  • Monitor studies and interpret results
  • Review reports and support their preparation
  • Summarize results and incorporate them into your IND or other submission

WHY US?

  • We will help you design, outsource, and oversee your study
  • We bring the expertise, experience and team your project demands
  • We can execute complete IND enabling preclinical programs
  • We act as your champion before FDA and other regulatory bodies
, PharmaDirections
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Drug Developers

We have seasoned experts in many different therapeutic moieties and indications that will strategize and build a full-spectrum team around your innovation to push it forward, into patients and toward approval.

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Program Managers

Our Program Leaders and Project Managers drive the execution of coordinated campaigns from drug discovery to preclinical research to clinical trials.

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Drug Discoverers

Our experts design and execute a variety of studies aimed at rational lead selection and optimization based on pre-established target product profiles.

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CMC Experts & Quality Managers

From sourcing starting materials to formulating your drug product, we provide expertise in chemistry, biology, formulation and manufacturing of both small and large molecules.

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Preclinical Experts

We design and oversee the in vivo and in vitro studies you need to assure regulators your molecule is safe enough to treat humans.

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Predictive Pharmacokinetic Modelers

We analyze PK data and use sophisticated computer tools to design dosage forms and optimize dosing regimens.

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Regulatory Experts & Managers

Our seasoned experts have helped advance countless new and repurposed drugs from investigational applications (e.g. INDs) through to marketing approval in the U.S. and abroad.

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Intellectual Property Inventors

Patent applications are part of regular routine. We generate your IP but we take no ownership stake in it.

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REQUEST A CONSULTATION

Contact Cathi Clark, our VP of Business Development to Get Started!

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