CLINICAL PHARMACOLOGY
Our SERVICES
- Provide high-quality scientific knowledge/insight and drive to your customized clinical pharmacology plans
- Drive timely execution of defined clinical pharmacology plans, with appropriate quality controls and high quality written report production
- Write, review and edit relevant sections of regulatory submissions - IND, IMPD, CTA, CSR, BLA etc.
- Lead writing of scientific publications on relevant topics - abstracts, posters, oral presentations and manuscripts
- Work collaboratively with research and development sciences on PK and PK/PD aspects of nonclinical studies
- Participate in the due diligence process delivering sound scientific analysis augmented by industrial experiences and attention to details
- Knowledge of evolving PK/PD regulatory requirements and climate in US, Europe and Africa
- Clinical pharmacology support of study design and conduct
- First in human, bioavailability/bioequivalence, in-vivo drug interaction, dose-response, early-phase in patients, confirmatory PK in late-phase studies
- Able to work on any phase of a clinical trial project, from the initial meeting with an investigator to final review of a manuscript prior to submission for publication or to FDA.
- Ability to collaborate a cross-functional trial and project teams, physicians, external government or industry representatives with regards to the pharmacokinetic aspects of each clinical trial or project
- Experience working with FDA and thorough understanding of FDA, OIG, HIPAA and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry
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Expects in study design, study execution, interpretation and report writing - related to PK and PK/PD assessment, providing high-quality scientific knowledge and insight to your customized clinical pharmacology programs.
We can help you predict investigational products by reviewing and cultivating minimal data sets requires unique and precise expertise.
bridge the gap between nonclinical and clinical data
Our Clinical Pharmacology team helps bridge the gap between nonclinical and clinical data, leading to extrapolation of response into the larger population.
experienced and knowledgeable team
We offer an experienced and knowledgeable team with extensive agency exposure to generate and support everything from program-level strategy, formulation of pharmacology documents, to plan operations and implementation
INDUSTRY TESTED
Count on our clinical experience, regulatory expertise, and proven industry reputation
Nonclinical and clinical development
- Nonclinical and clinical development support including pharmacology, toxicology, pharmacokinetic studies, biopharmaceutical, and ADME programs
- Bridging support between nonclinical and clinical data sets
- Extrapolating minimal data into human response prediction
CLINICAL PHARMACOLOGY
- Calculating proper dosing and sampling
- Defending exposure-response modeling in front of global regulatory bodies
- Strategizing program management of your small molecule, biologic, and immunoresponse clinical trials
- Writing specialized pharmacokinetics / pharmacodynamics publications, protocol design, biopharmaceutics summaries, briefing books, and all related study documents