We cooperate with many trial sites and laboratories in the European Union and abroad. Our partners provide us with access to a large and diversified (in terms of diseases and therapeutical needs) patient base. This is extremely important for the trial to generate authentic data about the device in comparison with the needs of a patient/physician.
When selecting the trial site, we consider the following factors:
-Demand for availability of the trial target group, considering the population size and therapeutic indication, as well as recruitment capacity of the site.
– Quality assessment of the services provided by the trial site: reporting timeliness, accuracy in drafting and collecting trial records, trial staff communication skills, compliance with laws and procedures, availability of qualified personnel and medical equipment meeting the legal requirements and requirements of the trial itself.
-Infrastructure, technology and expert resources of the site.
Who can be an investigator in a clinical trial?
The investigator shall be a person exercising a profession which is recognized in the Member State concerned as qualifying for this role on account of having the knowledge and experience in patient care. Please note that requirements depend on a given type of medical device. In the case of trials conducted in minors, the investigator or their designee must also have experience in working with minors.
Other personnel involved in conducting a trial shall be suitably qualified, by education, training or experience, in the relevant medical field and in clinical research methodology, to perform their tasks.
What are the investigator’s obligations?
Their obligations include:
- preparation for conducting a clinical trial, which includes reviewing the documentation of the trial and medical device;
- communication with trial subjects regarding the trial purpose, course, rights, risks and benefits;
- reporting to the sponsor any serious adverse event, except for those that the protocol or investigator’s brochure identify as not requiring immediate reporting;
- monitoring clinical trial conduct compliance with local laws;
- providing medical care to trial subjects.
Are all trials conducted at one location?
It depends on the therapeutic indications, target population and recruitment capacities at a given location. This is why sometimes several research facilities are involved in a trial.