Partners

Participant 11

Larix

Partner 11:
Larix Aps, Tempovej 44, 1, DK-2750 Ballerup, Denmark

Key skills:
Statistics, pharmacovigilance and data management

Laboratory background and technical information:
Larix was established as an independent company in 2001 based on the 20 years professional expertise of Dr. Olsen. The focus area of Larix is statistics and data management in the biotech and pharmaceutical industries and in hospital settings. Currently Larix has six employees and services a range of companies and hospital institutions. Larix has worked with a large number of different therapeutic areas and has extensive experience in performing statistics and data management according to regulatory guidelines.

Capacity to contribute to the project:
Larix will be a contact centre for collection of clinical data concerning the disease. Larix possesses a validated database system programmed in the SAS® software package. The system includes an audit trail facility in compliance with regulatory requirements. This system will be used for defining the database structure, for handling data cleaning processes, and for final storing of the data. The statistical evaluation and presentation of the data will follow generally accepted standards. Further, Larix will cover medical writing of the final integrated clinical report. Larix will provide pharmacovigilance and SUSAR reporting for all the clinical trials. All processes are covered by comprehensive standard operating procedures.

Personnel involved:

Klaus Juel Olsen (Head of the departement, PhD, M): will provide statistical input to the study protocol and act as advisor on statistical questions
Ulla Dindorp (PhD, F) will perform the database definition according to the protocol of the natural history study (4pm). Jens Sørensen, technical assistant, will handle the data
Helle Frimer-Larsen (F) will perform the statistical analyses. The analyses will be throroughly pre-specified in a statistical analysis plan, and documented in a final statistical report.
Pharmacovigilance of the trials will require a Safety Officer and a
Medical Safety Officer
Medical writer: The medical writing will be performed by a qualified medical writer with a background from the pharmaceutical industry

Key Publications:

Andersen L, Volund A, Olsen KJ, Plum A, Walsh D (2001) Validity and use of a non-parallel insulin assay for pharmacokinetic studies of the rapid-acting insulin analogue, insulin aspart, J Immunoassay & Immunochemistry, vol 22, 147-163