What we can do for you
- Identification of studies needed for registration purposes
- Study concept management : Request and quote negotiation with CROs
- Study organisation at CROs
- Technical contact for CROs and clients - from study plan preparation to the experimental phase and the final report
- Inclusion of endpoints and studies into dossiers (incl. summary writing)
- Our experts are used to linking scientific and regulatory requirements for different regulations (e.g. Europe, USA, Asia) – reduce the risk of having to pay for studies not fit for regulatory purposes.
- Working with a full service provider is time and cost efficient – no loss due to time consuming familiarisation with substance data at each new stage of the registration process.
- We are an independent consultant, we do not perform studies ourselves.
- Long-term experience with different CROs allows us to assist you in the selection process and give you advice on the basis of price-performance ratio, know-how and quality.
- The technical work is supported by experienced project managers and a centralised CRO Management.
Our Management & Monitoring Services in Detail
Our experts support you with management and monitoring of all relevant laboratory and field OECD and IOBC study types required for your submissions.
- Physico-chemical properties
- Environmental fate
- Residues, Metabolism, Analytical Methods
In addition, we can support with the design of entire programmes and data management for selected technical areas. For example, we
- Design cost efficient efficacy trial programmes covering EU regulation and all EPPO zones;
- Develop study plans according to GEP and relevant EPPO standards as well as national guidelines (e.g. CEB) for efficacy and crop safety trials as well as other special studies e.g. for baseline resistance, succeeding and adjacent crops, rainfastness, tank mix, cleaning equipment etc.;
- Manage your trial data with appropriate standard software (e.g. ARM).
- Preparation of the study protocol for migration and toxicological necessary studies, in relation to compliance testing and authorisation of new food contact substances.
- Study management and study monitoring of migration and toxicological studies for food contact materials / articles, and for food contact substances.