Newsummit engages in new drug R&D outsourcing (CRO) services. A Contract Research Organization (CRO) provides professional outsourcing services for pharmaceutical companies in the process of drug R&D. It encompasses all R&D-related technical servicesincluding pre-clinical research, clinical trials, data management, new drug regulatory application etc.
Newsummit is a professional CRO services provider. We strive to provide all-encompassing new drug R&D services for pharmaceutical enterprises, with an emphasis on pre-clinical research, clinical research and other consulting services.
Core Business Development
1．Pre-clinical research services
Pre-clinical research services mainly include pharmacokinetics / pharmacology / toxicology studies and clinical trial application, with the purpose of performing a systematic evaluation of drug candidates to determine whether they meet the requirements for clinical research.
Pharmacokinetics studies mainly includes process research, non- clinical scale drug supply, quality studies, establishment of quality standards, and stability studies; pharmacological and toxicological studies include pharmacodynamics, pharmacokinetics, safety evaluation, future indications, clinical trial planning etc.; clinical trial application mainly includes the establishment of all documentation required by the regulatory authorities to enter into clinical studies.
2. Clinical research services
Clinical research is a systematic study of drugs in humans (patients or healthy volunteers), in order to confirm or reveal their effects, adverse drug reactions, and / or absorption, distribution, metabolism and excretion features of drug candidates, so as to determine their safety and efficacy. It includes phase I – IV clinical trials. According to China's laws and regulations for drug registration, clinical research of drugs shall be conducted by qualified medical institutions. Newsummit’s clinical research services, under sponsor’s mandate, include establishing the clinical research protocol together with applicants and principal investigators, monitoring the clinical trial process, conducting clinical trial management, performing statistical analysis, as well as providing assistance in of the completion of clinical research reports..
3. Other consulting services
Other consulting and technical services are provided to our clients in the course of contract operation.