Clinical trial is the major tool to prove your innovation but post-marketing surveys (PMS) allow, under real-life conditions, to improve the knowledge on clinical and/or safety data, to establish risk management plan, and to support a long-term marketing development of your product.
PMS deal with marketed products that are prescribed in the usual manner and used in accordance with the approved label. There are no protocol-specific interventions/procedures. Therapeutic strategy, as well as decisions of management and follow-up, is strictly under the physician’s responsibility as per usual practice, and prescription is clearly separated from the decision to include the patient in the study. Moreover, epidemiological methods are used for statistical data analysis.
Which type of PMS for your study?
The study design is to be deeply discussed with our methodologists as the whole success of your project depends on it.
Here are the different types of PMS that can be proposed to you.
- Cohort studies and registries are an irreplaceable way to document real-life performance and safety of a drug.
- Case-control and other retrospective studies may be a great help in investigating rare adverse events.
- Cross-sectional surveys may be used to precise the epidemiology of a condition, for instance to identify the target population of a drug.
- Phone surveys and polls.
- Medico-economic evaluations.
- Post authorization safety studies (PASS): investigate the frequency of already known adverse events and possible rare adverse events not yet identified.
Our Services for your PMS:
- Methodological adviceon study design
- Manage the regulatory aspects related to such types of studies,
- Preparation of study documents(protocol, questionnaires, information and consent form (ICF)…),
- Selection of investigation sites,
- Organizing meetings for investigators,
- Site initiation by visits or by phone calls,
- Data monitoringby follow-up visits, phone calls, fax or emails,
- Data management,
- Statistical analysis and report,
- Study report and other types of publications or communications.
As for clinical trials, each PMS is handled by a dedicated project manager who can rely on an international operational team composed of operation assistants and epidemiological research associates (ERAs) who are able to travel all over Europe for the needs of your study.
Please feel free to contact us for further information and a personalised advice.