Dynakin’s Drug Modeling & Consulting (DMC) group operates as a CRO to the pharmaceutical industry in model based decision making with a strong component of translational and adaptive trial method application. DMC leverages both in-house and international partners offering high flexibility while reducing overheads.

The DMC group consultants (in-house and network partners) have over 20 years of accumulated experience in pre-clinical and clinical development who can respond with work adapted to your needs in all therapeutic areas. Our team also has extensive regulatory matter expertise and also in protocol and report preparation having prepared, consulted and chaperoned more than three major drug applications to the EMEA and the BfArM, among others.

The DMC working philosophy uses the Model Based Drug Development (MBDD) and translational medicine paradigms as promoted by the FDA. MBDD in translational drug development applies to all stages of drug development. DMC also has strong public domain data (meta data) analysis expertise and librarian partners for meta database compilation. Both MBDD and metadata efforts are integrated to assist in go/no-go decisions for your agent. Further, we can add more value to your development by assisting you not only through MBDD + metadata but also by providing reporting and regulatory support.

DMC MBDD services cover the complete spectrum from Non-Compartmental (NCA), to Compartmental analysis, PK/PD analysis, population PK/PD analysis and Trial simulation. Data handled can come from our bioanalysis laboratory, from the client, from public domain metadata or from all those.

All design analysis and reporting is based on ICH guidelines, following your needs and Dynakin SOPs. Security of data is assured by a range of measures, including limited data access to personnel, regular data saves and regular data print-outs.