According to a recent survey, 86% of companies have seen pre-clinical pharmacokinetic - pharmacodynamic (PKPD) analysis impact drug development. By choosing a CRO that specializes in clinical trial simulation and modeling, biotech and pharma companies can expect a higher return on investment, and are able to avoid regulatory obstacles and other hazards in their drug development program, including unnecessary cost of development, increased time to approval, or in some cases both.
With Synteract’s extended team of in-house PKPD scientists, we bring advanced pharmacometric modeling and clinical trial simulation technologies to both adult and pediatric drug development across the spectrum of therapeutic areas. Synteract’s PK/PD service offerings include:
Benefits to gain from successful implementation of simulation strategies can be enormous. Trial simulation strategies have been successfully employed to:
- Help determine the impact of formulation changes on clinical response and assist in optimal formulation selection based on both pharmacokinetic and pharmacodynamic considerations
- Help determine the most robust clinical trial design with respect to study design, patient numbers and number of dose groups, thereby minimizing time and cost
- Gain early insight on future dosing regimens, thereby expediting protocol development and compressing development timelines
- Risk mitigation potential offered in late stage clinical development where the use of modeling and simulation can substantially improve the quality of critical go/no go drug development decisions and help identify the optimal dose and dosing regimen to take forward into costly registration trials
Contact us to learn more about how Synteract can help with implementing appropriate PK/PD models or other aspects of modeling and simulation for your next clinical trial.
