Study Monitoring
Managing the conduct and design of scientific studies and programmes.
Our Approach
With the increasing complexity and cost of product safety studies, companies often require help.
We provide expertise in the design, management and data interpretation of studies to support the chemical industry. These may be for regulatory purposes or part of a product stewardship programme.
We cover all study types; physico-chemical, environmental fate, ecotoxicology and toxicology. We work with Contract Research Organisations and other institutions to generate appropriate data.
Support includes:
- Identification of studies for regulatory requirements, registrations and supporting mechanistic work
- Working with CRO partners to obtain transparent quotations for studies that are fit-for-purpose
- Liaise between CROs and clients providing the experience to ensure work is aligned with the regulatory and / or client requirements
- Data interpretation and explanation to clients of the study outcomes
- Preparing study summaries (IUCLID and OECD) for regulatory dossiers
Our study monitors are experts recruited from a wide range of scientific and regulatory disciplines. They have working GLP expertise, and several are experienced ex-study directors from GLP labs. We foster a collaborative culture aided by Active Steward™ to assist with the smooth and effective monitoring of the studies. In the unlikely event of issues arising, our study monitors have excellent working relationships with the CROs to aid with problem resolution. We understand that client confidence requires effective communication and timely updates for any outcomes of the study, that may have implications for your business.
We have extensive experience managing large projects with multiple on-going studies across disciplines and substances for individual clients and consortia.
Contact us today
Expertise in the design, management and data interpretation of physico-chemical, environmental fate, ecotoxicology and toxicology studies.