Smooth Drug Development delivers services on conduct of observational epidemiology programs after drug marketing authorization.
In today`s pharmaceutical and clinical practice, observational programs provide good opportunities for further product development: study of drug administration in long-term routine practice enables gathering new data on efficacy and safety, unveil specifics of its prescription to certain patient groups, drug interaction, and give an impulse to drug registration for new indications.
Observational programs are conducted after the producer has received the registration certificate for the medicinal product. These are non-interventional studies, which implies the use of the drug in accordance with the instruction for medicinal use and treatment standards.
As a rule, such programs do not assume special additional procedures and patient visits related to the program: patient diagnostics, treatment and observation are done in compliance with standard practice.
For data collection, electronic systems with an easy and convenient interface in the Russian language for doctors are used. This enables minimizing time for staff training and including sites with no previous experience in such programs. Programs can be executed using on-site as well as remote monitoring.
The following tasks are performed when conducting observational programs:
- Collection of information on safety and efficacy of the drug
- Study of drug interaction with other drugs
- Study of drug influence on laboratory parameters
- Study of drug use in different age groups
- Study of drug use in patients with different associated diseases
We provide the following services within observational programs:
- Definition of the program goal and tasks
- Program feasibility assessment
- Program documentation preparation
- Approval of the study at Independent Ethics Committees
- Site selection and management, including trainings
- Collection and cleaning of data
- Statistical analysis
- Program report preparation
- Preparation of scientific articles, monographs, brochures based on program results