Translation Research & MIDD

A Fully Integrated Approach to Translational Development that Drives Clinical
Success

Offerings that Span CMC, Pharmacology, Nonclinical Services, and Model-Informed Drug Development (MIDD)

At Premier Research, we provide integrated, end-to-end clinical pharmacology; chemistry, manufacturing, & controls (CMC); and nonclinical services that empower smarter, faster drug development. Our cross-functional approach comprises clinical study design, nonclinical safety, toxicology, pharmacology, pharmacometrics, pharmacokinetic/pharmacodynamic (PK/PD) modeling, CMC, and regulatory strategy—working together to deliver strategic translational pharmacology, model-informed drug development (MIDD), and clinical study support to reduce risk and improve success rates.

Translational pharmacology bridges the gap between discovery and clinical success. By translating nonclinical insights into strategic clinical plans, and aligning them with formulation and CMC considerations, we enable rational dose selection, optimized trial design, and early regulatory alignment.

In close partnership with our clinical and regulatory strategists, our experts craft development plans that integrate nonclinical, CMC, clinical, and regulatory strategies with strategic modeling to inform smarter decisions at every step—from preclinical activities to first-in-human (FIH) studies to pivotal trials.

Chemistry, Manufacturing, & Controls (CMC) Services

Strategic CMC Planning

We’ll help align your development goals with regulatory expectations from the beginning, including strategic input on formulation, dosage form, and protocol design.

Manufacturing Planning

We leverage our robust network of contract development and manufacturing organizations (CDMOs) to help you identify the most suitable service providers for optimal delivery of your drug substance and drug product—on time and on budget.

CMC Documentation and Regulatory Support

We define optimal validation strategies to secure accurate document preparation, technical review, and regulatory compliance.

Nonclinical Services & Toxicology

Strategic Nonclinical Planning

We support strategic nonclinical planning through IND-enabling study design, human equivalent dose (HED)-based FIH dose selection, and safety screening using in silico, in vitro, and in vivo models.

Nonclinical Study Design & Execution

We provide full management of GLP and non-GLP nonclinical studies, leveraging deep experience across all major species and therapeutic modalities, including small molecules, oligonucleotides, and gene therapies.

Specialty Expertise

We offer specialized expertise in designing studies for juvenile and combination toxicity, cell and gene therapies, and oncology and immunology programs. Our capabilities extend to repurposed drug programs, including those utilizing the 505(b)(2) regulatory pathway.

Clinical Pharmacology & Pharmacometrics

Tailored Clinical Pharmacology Development Plans

Our tailored clinical pharmacology development plans integrate translational and systems pharmacology with in-depth ADME, metabolism, and excretion analyses. We provide drug-drug interaction modeling and assess drug effects in special populations.

Study Design & Protocol Development

We design strategic clinical studies including SAD/MAD, food effect, crossover, BA/BE, and dose-ranging trials, along with placebo-controlled, non-inferiority, superiority, and quality-of-life (QoL) studies. All protocols are developed with a focus on regulatory expectations and long-term success.

Clinical Execution & Regulatory Writing

Our team oversees bioanalytical method validation, delivers comprehensive data analysis and biostatistics, and provides expert medical and regulatory writing. We ensure all documentation is eCTD-compliant and ready for submission in accordance with ICH standards.

Model-Informed Drug Development (MIDD)

We de-risk development and improve outcomes by integrating predictive modeling into your program. Our MIDD capabilities include population and sparse-sampling PK/PD modeling, clinical trial simulation, and outcome prediction. MIDD enables smaller, smarter studies and fosters early regulatory alignment, improving resource use and minimizing costly late-stage failures.

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