In January 2013 Independent laboratory INVITRO opened a new direction - Contract Research Organization (CRO).
The expansion of INVITRO’s services indicates growing needs of the pharmaceutical and biotechnological market in the effective approaches of the organization of clinical trials in Russia.
It is a unique offer in the Russian market to combine the CRO and Laboratory. INVITRO allows Sponsor to obtain the necessary services to the company serving as CRO and the Central Laboratory at the same time.
CRO offers a full range of solutions for the organization and conduct of clinical trials phase I-IV in Russia (including bioequivalence studies and observational studies):
- Selection of the Sites depending on the requirements of protocol;
- Preparation of a complete set of documents for authorization of clinical trials including the highly qualified translations into Russian;
- Organization of the delivery of the study drug and comparator drugs in the Russian Federation Delivery of the study medication, medical equipment and related materials to Sites;
- Ensure storage of biological samples and materials for the study;
- Monitoring of Sites;
- Project management;
- Development of the trial protocol, investigator's brochure, informed consent, CRF and other required documents;
- Biostatistical processing and data management and reporting on clinical trials;
- Contracts with clinical centers and investigators;
- Legal and Information Support;
- Organization of the central laboratory work.
INVITRO has more than 14 years of experience of cooperation with pharmaceutical companies and contract research organizations (including the field of quality control and logistics) as well as experience in working with Russian regulatory authorities which gives our company additional benefits in the area of improving the quality of services provided.