Kinesis’ clinical consultants offer state-of-the-art expertise in measurement, quantification and evaluation of a drug’s biological activity in humans. This expertise will help sponsors to design the optimal early phase development program and individual clinical trials such as first-in-man (SAD/MAD), biomarker (e.g. PET), proof-of-concept (POC), drug-drug interactions, bioavailability/bioequivalence (BA/BE), food effects, radiolabeled ADME, thorough QTc, and special populations (liver, kidney, pediatrics, elderly) studies.
Our clinical consultants have experience with various disease targets and in a variety of disease area’s, such as virology, CNS, asthma/COPD, dermatology, cardiovascular, urology, oncology, rheumatoid arthritis and psoriasis. In addition, Kinesis can lean on and make use of an extensive clinical network of key experts.
Nowadays biomarkers are used to obtain early hints of clinical activity and help to determine an optimal dosing schedule as early as possible in the program. Up-to-date knowledge of biomarkers, measurement techniques and indications is required. Therefore Kinesis’ clinical consultants continuously update their knowledge, especially in those areas requiring their regular involvement. A close collaboration with an academic network of specialized clinics ensures utilization of best practices and the latest knowledge and techniques.
Clinical development program
Kinesis’ clinical consultants can help sponsors with various activities in clinical development ranging from designing a single clinical trial, selection of biomarkers, or providing input to dose escalation steps during a trial, to providing full clinical development programs, pediatric investigation plans and participation as clinical pharmacology or PK/PD experts in (global) project teams.
Outsourcing clinical development
Outsourcing (part of) the clinical development program (e.g. up to Proof of Concept) to Kinesis is also a possibility. In these cases a clinical project team within Kinesis with representatives of all disciplines needed for clinical development (i.e. a clinical consultant, clinical trial manager, pharmacokineticist, pharmacometrician (if applicable), statistician and medical writer), will take care of all clinical activities needed to bring the compound to its next milestone.