Service profile

Services include: 

• Custom design of R&D programmes.
• Contract research organisation (CRO) selection.
• Coordination and follow-up of studies.
• Study design and protocol review of in vivo and in vitro studies (ADME, toxicology, and secondary pharmacology).
• Pharmacokinetic (PK) and toxicology data analysis and reporting.

ETS Nederland mediates between Sponsor and CRO, objectively selects CROs that best suit the needs of the Sponsor, and gives the Sponsor insight in true costs.

PK and toxicology data are analysed within competitive timelines and discussed with the Sponsor’s project team.

Other services include:

• Preparation of expert reports.
• PK summaries.
• Toxicology summaries.
• Contributions to Investigator’s Brochures (IB).
• Investigational New Drugs (IND).
• New Drug Applications (NDA).
• Dossiers According to Directive 91/414/EEC.
• Biocidal Product Directive 98/8/EC, etc.
• The preparation of manuscripts for scientific journals (ghostwriting).

In-sourcing and staff training courses can be organised upon consultation.