Inncelerex
Inncelerex specializes in supporting drug development across all stages, including candidate selection, toxicology, pre-clinical, early clinical development, late-phase clinical trials, drug registration, and post-marketing requirements. Their integration of scientific and regulatory expertise in clinical pharmacology, modeling and simulation, translational medicine, toxicology, and pre-clinical safety offers comprehensive solutions to enhance program design, execution, and strategic decision-making. They manage a broad spectrum of studies such as clinical pharmacology, pharmacometrics, pharmacodynamics, toxicology, and ADME studies, ensuring program efficiency and precision.
Industries
Nr. of Employees
small (1-50)
Inncelerex
Services
Design and operational support for clinical pharmacology studies (SAD/MAD, DDI, FE, ADME, BE/BA, TQT, special populations and pediatric studies), including CRO placement, PK analysis and reporting.
Review of pharmacology/toxicology packages, pre-IND meeting preparation, Phase 1A/B study design, dose escalation strategy, NCA/POP-PK and exposure–response analysis to identify RP2D.
Design and oversight of in vivo and in vitro pharmacology, ADME and GLP toxicology studies, preparation of carcinogenicity and special protocol assessment packages, pathology peer review and reporting to support IND and registration.
Development of population PK/PD models, exposure–response and exposure–safety analyses, pediatric extrapolation and design of optimized PK sampling schemes to support dose selection and regulatory submissions.
Preparation and support for regulatory interactions including pre-IND, IND, End of Phase meetings, Type A/B/C meetings, NDA/BLA submissions and post-marketing discussions with FDA, EMA, MHRA and PMDA.
Design and analysis of pivotal study Clin Pharm components, preparation of submission-ready modules (2.7.1/2.7.2), Clin Pharm sections of labeling, NDA/BLA briefing and rapid-response support for authority information requests; regional registration planning including Japan and China.
Design and operational support for clinical pharmacology studies (SAD/MAD, DDI, FE, ADME, BE/BA, TQT, special populations and pediatric studies), including CRO placement, PK analysis and reporting.
Review of pharmacology/toxicology packages, pre-IND meeting preparation, Phase 1A/B study design, dose escalation strategy, NCA/POP-PK and exposure–response analysis to identify RP2D.
Design and oversight of in vivo and in vitro pharmacology, ADME and GLP toxicology studies, preparation of carcinogenicity and special protocol assessment packages, pathology peer review and reporting to support IND and registration.
Development of population PK/PD models, exposure–response and exposure–safety analyses, pediatric extrapolation and design of optimized PK sampling schemes to support dose selection and regulatory submissions.
Preparation and support for regulatory interactions including pre-IND, IND, End of Phase meetings, Type A/B/C meetings, NDA/BLA submissions and post-marketing discussions with FDA, EMA, MHRA and PMDA.
Design and analysis of pivotal study Clin Pharm components, preparation of submission-ready modules (2.7.1/2.7.2), Clin Pharm sections of labeling, NDA/BLA briefing and rapid-response support for authority information requests; regional registration planning including Japan and China.
Expertise Areas
- Clinical trial design and execution (Phase I–III)
- Clinical pharmacology and human pharmacokinetics
- Pharmacometrics and modeling & simulation
- Pre-clinical safety, toxicology and ADME
Key Technologies
- Population pharmacokinetic (popPK) modeling
- Noncompartmental analysis (NCA)
- PK-PD and exposure–response modeling
- Exposure–QT analysis