maxclinical is an international connected research organization (virtual full service CRO) providing clinical services for industry academic research and NGOs. maxclinical brings in the experts for clinical project management, statistics and data management, clinical operations (monitoring and regulatory), risk and performance management, budget monitoring and control. maxclinical provides the one stop shop for a clinical project. By its partnership model maxclinical can reach patients and sites in Europe and in India. maxclinical provides the suitable technology for each business case and for each project - central clinical trial portal for all services (CTP) - electronic data capture (EDC) integration of different systems - selection and provision of central randomization systems, IxRS (IVRS and IWRS) - clinical trial management systems (CTMS) - electronic patient recorded outcomes (ePRO) - document management and electronic trial master files (eTMF) maxclinical delivers special expertise in - risk metrics and risk management - performance metrics and performance surveillance supporting risk based monitoring approaches to clinical trials maxclinical helps in - standards (CDISC) implementation and compliance - eClinical programs - vendor selection and management - project management and coordination - compliance management and systems validation (GAMP 5, CFR 21 part 11, GMP annex 11) - business process analysis - SOP management and writing