Security, quality and transparency
- 2017-08-02 09:00:00
- Generic
The most important partners of Szinapszis Ltd. are undoubtedly the domestic and foreign pharmaceutical companies, and the regular audit of their contracted suppliers has become a part of their protocol in the recent years. These large pharma companies work with a huge social responsibility, so it is very important that their partners also attach great importance to security and transparency. Szinapszis Ltd. does its best to meet the requirements of their clients, give only high quality research work out of its hands, and handle the data of every participant confidentially and securely.
Security protocol audits with international supervision
The importance of these audits is demonstrated by the fact that not only the local, Hungarian departments of pharma companies conduct them, but also the representatives of the global companies. Previously the Roche, not so long ago the Novartis and the Sandoz audited us or held a pre-qualification survey, and soon the Takeda will come to us. These audits focus on two main areas: the pharmacovigilance and the quality management system.
Pharmacovigilance (PV) trainings are becoming more and more important also in the health care market research. This means that before starting a research, our colleagues who work in the project participate in an online or telephone training. Within the confines of the training they make the client company sure that if any health care practitioner or patient mentions an adverse event or side effect, they will report it to the company’s local drug safety department in 24 hours (or immediately in some cases).
During the audits, the representatives of the clients look through the documentation of the employees who have participated in the training, check if everything is properly administrated, and randomly review a project and listen to the research audio recordings. Szinapszis Ltd. places a great emphasis on the adverse event reporting knowledge of every employee, completely documents everything and keep every research material safe in case of future audits. Our goal with our work and research is to support health care and help to create a healthier society.
Our quality management system
In the second half of the audits the quality management system of our company has been checked by the clients. Their main goal is to make sure that the internal protocol of their partners corresponds to their standards. Szinapszis Ltd. is constantly working to meet entirely these expectations, ensure the safety and transparency of the work and data.
It is extremely important to administrate all processes in detail, and have comprehensive data protection with passwords and firewall. We are archiving every research material by the required method and time. The training and administration of our employees have a special importance: the job descriptions and CVs of our colleagues are constantly updated and they regularly participate in pharmacovigilance and quality management trainings.
Changes and unexpected situations are constant attendants of business life, and this is also the case in the field of market research. Nowadays it is a basic expectation to be prepared for the managing of different complaints and ‘force majeure’ situations. Our business continuation plan details how we could continue the work if some serious problem would happen (e.g. a long blackout). The auditor pharma companies look through and examine these plans to see how prepared, reliable and prescient we are.
The last important requirement is that we should audit ourselves and our suppliers as well. We constantly have to check the data protection and administration of our completed projects, and also the reliability and timeliness of our softwares. Furthermore, we have to require the same from our partners, for example from the contributor moderators who help us with certain qualitative interviews. We have to organize the necessary trainings for them, audit their work, just to be sure that they are also working to the expectations and requirements of the pharmaceutical companies.