We have strong expertise in the development of sophisticated study concepts that respect the special conditions of natural products where the effect is concerned. This effect, compared with standard pharmacological products, is usually more gentle and delayed. Therefore, study populations, parameters and their documentation, study conduct and analyses must be planned thoroughly and carefully. We help you to get the best out of your product.
analyze & realize GmbH as a Contract Research Organization (CRO) has long-standing experience in designing, planning, implementation, evaluation and publication of clinical trials to obtain/extend the product approval or optimize product marketing, e.g.:
- Drug trials (phase II-IV)
- Medical device investigations
- Food studies (food supplements, functional food and PARNUTs)
- Studies for substantiation of Health Claims (according to current EFSA guidelines)
- Non-interventional studies (NIS), observational studies
- Pilot studies
Our core competence lies in the conduct of studies with:
- Herbal drugs
- OTC / Rx drugs
- Food incl. dietary, functional food and PARNUTS
- Medicinal waters
- Medical devices
Our broad network of experienced investigators, specialized clinics (e.g. Charité University Berlin) and accredited partner laboratories as well as our associated study site with dedicated physicians allow for high quality and efficient performance of clinical trials.
As member of Federal Association of Medical Contract Research Institutes (Bundesverband medizinischer Auftragsforschungsinstitute, BVMA) and European CRO Federation (EUCROF) we are regularly audited and certified.
Our quality management is based on extensive standardized operating procedures (SOPs) for conducting studies with drugs, medical devices and food products, in line with legal requirements and international regulations such as:
- ISO 14155
- Deklaration von Helsinki
- EFSA Guidances
We constantly train our staff in GCP, SOPs, and regulatory affairs. Additionally, we undergo regular internal and external audits.