Key to a great Phase II study is gathering a fast and reliable signal for the drug’s effectivenes while keeping track of safety signals. We set a high value on our monitoring activities since Phase II studies also pay attention to any short-term side effects and safety risks associated with the dosing of the investigational drug in order to optimize the dosing. For timely effectiness we offer a structured and streamlined Project Management to coordinate all steps and processes related to your clinical trial, which includes a structured risk management approach. Long-term experience won in cooperation over years with investigators will help our Regulatory Affairs team to select suitable sites. Our training and quality control grants an efficient study execution, beginning with site selection and followed by site initiation and constant monitoring.
Through our ongoing risk-based approach we assure compliance with ICH/GCP as well as local laws. We offer clear and concise protocols and presentation of study results which are penned by our medical writers. They are equipped with excellent written language skills and will ensure consistency with the different styles of the addressees. Our statisticians are concerned with validated statistical programming and development of analysis databases with complete audit trail and metadata according to CDISC standards, if required. In the end of Phase II clinical trials, they prepare the analysis of results for the clinical study report and support medical researchers in preparing their publications and scientific presentations in close collaoration with the sponsor.
