Clinical studies are considered to be the highlight of the medical world and have great influence on treatment and determining health policies. In most cases they are initiated and funded by medicinal or pharmaceutical device companies.
These standards enable you to:
Decision crossroads regarding clinical studies
Pharmaceutical / medical device companies, especially those conducting international, multi- centered clinical studies, are compelled to deal with a number of challenges during the clinical study. This is especially the case if the results of the studies will be part of the registration file submitted to the FDA in the USA, the EMA in Europe and/or the Israeli Ministry of Health.
- Amongst these challenges are choosing a CRO and CRAs that are to ensure that: the study will be of high quality according to the requirements of the health authorities while maintaining the rights of the participants/patients and choosing investigators experienced in conducting clinical studies in Israel according to the GCP.
- Training the investigator and his staff to fully comply with the requirements of the study protocol and the GCP guidelines is an essential step in ensuring the success of the study.
- One of the keys for complete compliance of the study protocol is regularly developing and maintaining the professional knowledge of the staff conducting the study in the hospital and the community in order to confirm that the study is conducted properly according to the local GCP guidelines.
- Sometimes, a lack of knowledge and experience interferes and may lead to unnecessary expenses and not accomplishing the goals of the study.
- Preparing and submitting a request for the approval of a clinical study to the Helsinki committee in a medical institute or to the Ministry of Health requires deep familiarity with the regulatory requirements in order to enable conducting a clinical study in Israel.
- Pharmaceutical/medical device companies are required to translate the consent form in a professional medical manner into Hebrew/Arabic/Russian/English for the participants of the study.
- During the process of conducting a medical study, monitoring suppliers and service providers is required.
- During the process of conducting a medical study, close coordination between the initiator, the investigator and his staff, and the patients is required.
- Monitoring, reporting and documenting side effects and any other safety information are the basis of every clinical study and requires deep familiarity with the requirements of the health authorities.
Our services in the field of Clinical studies
Blau Pharmaceutical Services offers you, amongst other services, the following services atinternational GCP standards, that will enable you to manage clinical studies in Israel according to the study protocol and to achieve the following goals:
- Comprehensive management of the study conducted by an experienced and professional project manager
- Meticulous monitoring services performed by a CRA
- Monitoring, reporting and documenting side effects read more…
- QP- Batch release of the medicines for the study read more…
- Documents for the study (such as: consent form, protocol, handbook for the investigator, diaries, CRF): Medical writing, editing and ongoing management
- Medical translation of the study documents using certified translators
- Study site: feasibility, support in choosing the investigator, pre-study visit, staff training and preparing the site for conducting the study
- Preparing and submitting a request for the approval of the clinical study (Helsinki committee) and/or to the Ministry of Health according to the requirements in Israel.
- Coordinating and conducting investigator meetings
- Regular updates regarding changes of the health authorities’ requirements for performing clinical studies in Israel and internationally
- Advice regarding the budget and preparation of agreements with suppliers that comply with the determined standards
- Handling all the logistic aspects during the study such as: supplying the medicine of the study, payments
- CRO control
In conclusion, Blau Pharmaceutical Services supplies international standards of quality starting from the planning of the study, throughout its implementation and up to its conclusio