Study monitoring support

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Independent study monitor

To obtain a successful toxicology package,  it is essential that preclinical studies are designed appropriately, conducted in accordance with the proper regulatory framework, and reported with clarity, within the required timelines and budget.

An independent study monitor helps with the selection of the right Contract Research Organization (CRO), and ensures delivery of a high quality product that meets the regulatory requirements. Not having this oversight can lead to study results that are not fit-for-purpose and consequently to delays, duplication of studies, and increased scrutiny by regulators; all of which can be expensive.

Our monitoring services in detail

(Veterinary) Pharmaceuticals, Chemicals and Medical Devices:

Planning, organization, as well as oversight and interpretation of outsourced in chemico, in vitro and in vivo toxicological studies according to GLP, OECD (chemicals), (V)ICH ((veterinary) pharmaceuticals), ISO (medical devices) and other guidelines:

Conception of toxicological studies as part of project planning

Selection of contracting research organization (CRO) and support of audits

Study monitoring

Type of toxicology studies

We have extensive experience in establishing and monitoring in chemico, in vitro and in vivo toxicology studies for the following endpoints:

Frequently Asked Questions

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