Kinesis, CRO: PROJECT MANAGEMENT AND STUDY MONITORING

Kinesis: CRO in Drug Development and pharmacokinetic

CRO SERVICES FOR PRECLINICAL DRUG DEVELOPMENT

Preclinical CRO services	Clinical CRO services	Regulatory CRO services	Population PK/PD modeling	Ghostwriting	Insourcing
o preclinical consultancy.htm o Study design and protocol writing o Pharmacokinetic analysis and reporting o Project management and study monitoring	o Clinical consultation o Study design and protocol writing o Biometrics and report writing o Project coordination	o Regulatory affairs consultation o Regulatory documentation o Expert reports o Actualisatie oude dossiers	Population PK/PD modeling	Ghostwriting	Insourcing

4. PROJECT MANAGEMENT AND STUDY MONITORING

Kinesis employs individuals which handle full project management of the preclinical development of pharmaceuticals and biotechnology products. This includes the design of the program, the selection of CROs for the in-life phase of the study and for bioanalysis, the organization of all necessary communication with CROs and representation of the sponsor as study monitor for all outsourced studies. The selection and evaluation of CROs is being performed according to Standard Operating Procedures and is mostly based on their experience and track record for specific studies. Kinesis can act as study monitor (act as first point contact) on behalf of the sponsor for outsourced studies.

Study monitoring is performed according to Standard Operating Procedures. Furthermore all non-clinical regulatory documentation can be prepared, either for projects managed by Kinesis or on the basis of data delivered by the sponsor.

If asked for, we also report the results of studies to sponsors project teams and advise on the impact of the results on the development program.
Data analysis results are reported according to our report template or according to a template provided by the sponsor.

Address:

Lage Mosten 29
4822 NK Breda
The Netherlands
+31(0)76 54 80 666
+31(0)76 54 21 777 (Fax)

(c) 2003-2004 Kinesis, the Netherlands
info@kinesis-pharma.com