NB&A's Services

NB&A services span all phases of clinical trials, from conception to data management and reporting:

	The conception phase Critical evaluation of available data Product study Conception of a product development plan Writing of an investigator brochure
	Protocol preparation Phase I studies Bioequivalences Pharmacokinetics studies Pharmacodynamics studies Phase I to III studies CRF development and design (w. patient diaries) Translation of necessary documents in local languages
	Regulatory process Preparation and follow up of regulatory authorities authorizations in Croatia, Czech Republic, Italy, Latvia, Poland, Slovenia
	Quality assurance CRF vetting, including those CRFs manged by sponsor Adverse Event coding (WHO-ARTdictionary) Query generation and resolution, including on sponsor managed studies Quality check on databases on all data and/or Quality check of a random extracted database sample On-site audit visits AE Management
	Data management & statistics* Database design, entry forms design Design and coding of input validation programs Data entry Statistical analysis of study data Tabulations and listing, tailored to the study specifications *Data management & statistics tasks can be performed on study material originated by sponsor conducted studies

The conception phase