Our highly skilled PK group works closely with the study project team throughout all phases of study conduct (from design to report) to ensure that the study meets design endpoints with emphasis on PK/PD relationships and efficacy.
- Pharmacokinetic, statistical consultancy and full clinical study design
- Bioanalytical data reviews, interpretation
- Full data analyses reporting services
- Single study or program packages for same scientist review of program data
- Compliance focused in accordance with GLP, GCP, CTD and relevant ICH, EMEA, and FDA guidelines
Our experienced Statisticians and Programmers are dedicated for phase I-II projects and provide:
- Statistical consultation, study design and review
- Regulatory agency representation and support
- Statistical analysis plans and statistical programming
- Flexible / adaptive analysis plans
- Statistical & integrated statistical/clinical study reports/efficacy summaries
- Annual updates for regulatory agencies
- DSMB / IDMC support and summaries
Integrated Clinical Report Compilation and Publishing: comprehensive high quality reports designed to derive the optimum information from a study:
- Integrated PK, PK, PK/PD and stats interpretation
- Data presented in tables and graphs via WinNonlin and/or SAS
- CTD or eCTD formats including the clinical study report and Appendix 16 ( Module 5.3)
- Complete inter- and intra- document references (hyperlinks, bookmarks and indexing)
- Appendices and CRFS supplied as separate files compliant to ICH E3 specifications
- Files are insertable into .xml backbone for smooth and efficient submission
Read about one of our valued scientist's reports from an international publication:
Phase 1 and Pharmacokinetic Study of Weekly Docosahexaenoic Acid-Paclitaxel, Taxoprexin®, in Resistant Solid Tumor Malignancies - Co-Author, ChauHwei J. Fu, AAIPharma
Full Text PDF
Online Synopsis
RELATED SERVICES
The Pharmacokinetics group form close interactions with project teams in departments throughout AAIPharma, including:
- Data management and biostatistics
- Bioanalysis
- Phase I to IV units
- Specialist oncology unit
