High quality data that accelerates product development
Accelagen’s biometrics team have demonstrated expertise in designing and executing a broad study series focused on the clinical side of drug development.
Our pharmacokinetics capabilities support your drug development’s success rate by providing meaningful data and recommendations about drug dosage and interaction.
- Strategic analysis of pharmacokinetic profile to characterise ADME
- Preparation of Pharmacokinetic Analysis Reporting using Certara's WinNonlin
- Blinding and analysis of Pharmacokinetic data for DSMB/Safety Review Committee evaluation
- Providing expert interpretation of data to effectively characterise PK observations for objective decision making
- SAS programming of the study CDISC datasets to deliver PK datasets
- WinNonlin workflows integrate a variety of model-based analyses, including bioequivalence, fed-fast and drug-drug interaction studies
How we work
Cutting-edge technology
Accelagen uses best-in-class systems for information capture including inventory management and dispensing, patient reported outcomes and lab data.
Meticulous data handling and analysis
Our attention-to-detail and quality assurance maintains the integrity of your data from start to finish, and results in findings and recommendations that are backed by robust evidence.
Accessible, interoperable and reusable findings
We adhere to global standards, including the Clinical Data Interchange Standards Consortium, making sure data can be transferred across international markets.
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Tailored clinical development data
Our certified analysts build study workflows that deliver pharmacokinetic datasets as part of the end of study package, ready for regulatory submission.
Pharmacokinetics
case studies
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