Supervisory programs
Currently, supervisory programs play a significant role in pharma and clinical medicine, allowing further development of medicinal drugs. The study of drug administration in a real clinical practice environment provides new information about its safety and benefits, helps identify administration specifics in different patient groups, interaction with other drugs and may stimulate the process of registration of the drug for new indications.
These programs are implemented only after the drug receives an official registration certificate. They do not interrupt the standard treatment process and are administered as per the instructions for use in compilance with the commonly accepted clinical practice standards. Within such programs there is no need for special procedures or additional visits related to the study: diagnostics and patient treatment are conducted according to usual clinical practice.
We use electronic systems with user-friendly interface for data collection, which reduces the time spent for personnel training and helps to implement the program into centers which have not had experience with similar trials. The program can be conducted both remotely and with personal center visits by our specialists.
Within supervisory programs we:
Collect information about the safety and effectiveness of the drug
Analyze the interactions of the drug with other medicines
Assess the influence of the drug onto lab indicators
Research administration of the drug in various age groups
Analyze the administration of the drug to patients with various concurrent illnesses.
Our services include:
- Setting aims and goals of the supervisory program
- Assessing realization opportunities
- Developing program documentation
- Obtaining the approval of the program by independent ethical committees
- Selecting and training clinical center personnel
- Collecting and analyzing data
- Statistically managing the collected data
- Forming the final report
- Developing scientific publications, monographs and information materials based on program data