Kinesis, CRO: PHASE I PROJECT COORDINATION

Kinesis: CRO in Drug Development and pharmacokinetic

CRO SERVICES IN CLINICAL 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. PHASE I PROJECT COORDINATION

Kinesis can assist in the execution of clinical trial programs (see also Clinical consultation) by acting as study coordinator. We objectively select the CRO that best suits the need of the sponsor (e.g. the Phase I units or the lab that performs the bioanalysis), intermediate between sponsor and CRO, write the study protocol, follow-up when the study is ongoing (act as first point contact), analyse and report the study (see Biometrics and report writing). In fact, a sponsor can entirely outsource their phase I/IIa program.

For some sponsors we also report the results to the project teams and advise on the impact of the results on the development program.

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