Pure Clinical is a company which supports investigators in designing, registering, conducting and finalizing clinical trials of medical devices and performance evaluation of in vitro diagnostic medical devices.
Our offer for the investigators we cooperate with includes
- contact with the sponsor at the trial design stage
- analysis of legal requirements and other applicable guidelines
- preparation of the required trial file
- documenting results and events
- staff training
- coordinating investigating team work
- supervision over visits
- participation during trial inspection, monitor visits and third-party audits
- trial insurance
- investigational device documentation review
- assistance in subject recruitment and population retention in the trial
- support in adverse event reporting
According to Regulations 2017/745 and 2017/746, “investigator” means an individual responsible for the conduct of a performance study or a clinical trial at a performance study site or clinical trial site.
The investigator shall be a person exercising a profession which is recognised in the Member State concerned as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care. Please note that requirements should also be referred to a given type of medical device.
Other personnel involved in conducting a clinical investigation shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.
In the case of trials conducted in minors, the investigator or their designee also has experience in working with minors
The investigator’s duties include:
- thorough preparation for conducting a clinical trial, which includes reviewing the documentation of the trial and medical device;
- informing the trial subject about the clinical trial and its purpose;
- informing the trial subject about the possibility to obtain additional information regarding their rights, including the right to withdraw from the trial;
- providing the minor with information regarding the clinical trial, risks and benefits involved, according to their capacity for understanding;
- 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 clinical trial subjects;
- taking into account at all times the wish of a minor who is capable of forming an opinion and assessing the information, to refuse participation in or to be withdrawn from a clinical trial;
- taking into account at all times the wish of a person who is capable of forming an opinion and assessing the information, to refuse participation or to be withdrawn from a clinical trial.
The facilities where the clinical investigation is to be conducted shall be suitable for the clinical investigation and shall be similar to the facilities where the device is intended to be used.
