At InCROM, we are committed to reducing the workload of clinical trial sponsors.
Here we introduce the flow of our clinical trial business and the features of each stage.
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Contact us ・ Feasibility Study |
Accurate and prompt feasibility study We have built up a volunteer panel of approximately 180,000 people, including medical information. We can quickly identify potential subjects and conduct feasibility studies. Support for clinical research and food monitoring studies We can provide research services for clinical trials and all other types of clinical trials (clinical research, food monitoring trials, etc.). Estimated costs can be calculated right from the start of your inquiry If you provide us with an outline of the trial, we can calculate the approximate cost. New initiatives outside the clinical trial business Utilizing our volunteer panel of approximately 180,000 people, we are conducting marketing research business and subject recruitment support business. |
| Site selection survey | Coordination of interviews with potential investigators When conducting site selection surveys, we meet with potential investigators in person or remotely. Our sales representatives will coordinate the site schedule. Highly accurate site selection survey In addition to the investigator candidates, we strive to have the investigator secretariat, CRC, and subject recruiter attend the site selection survey interviews in order to make a comprehensive judgment. Centralized contact for the provision and preparation of selection materials Regardless of the site, our sales staff or secretariat support staff will be in charge of providing and preparing materials related to site selection. |
| Clinical trial preparation to clinical trial contract | Centralized contact point for clinical trial administrative procedures The person in charge of the secretariat will be the point of contact for clinical trial administrative procedures. Arrangement of materials required for clinical trials The clinical trial secretariat arranges the necessary materials for the clinical trial, and prepares the system at the site in accordance with the client’s intentions. Centralized point of contact for clinical trial costs and clinical trial contracts Our sales staff will be the point of contact for operations related to clinical trial costs and contracts. |
| IRB review | IRB of Osaka Clinical Research Hospital to be held at high frequency The IRB at Osaka Clinical Research Hospital conducts a review every three weeks. It also accepts reviews of clinical trials at medical institutions that are not supported by InCROM. Use of Agatha to streamline and simplify procedures The IRB at Osaka Clinical Research Hospital uses Agatha to create standardized forms and digitize IRB discussion materials. Full support for clinical trial review procedures Upon request, IRB office support staff will provide support for clinical trial review procedures. |
| Start of clinical trial to completion of clinical trial | Preparation of medical records for clinical trials in InCROM format The CRC in charge prepares the medical record for clinical trials, taking into account the input into EDC and direct viewing. Efficient selection of candidate subjects By making full use of the database of registered volunteers, we can narrow down the candidate subjects in advance according to the conditions of participation, thus enabling efficient medical record screening. Study progress management Every Monday, we share the progress of the study within the company and manage the progress. If there are any delays, we will promptly consider and implement corrective measures. Subjects’ visit management The management of subjects’ visits is systematized, and even in the event of a sudden schedule change by the subject, it is possible to promptly adjust the visit within the permissible range of the clinical trial plan. Direct reading room in a well-equipped environment Each of the facilities of Heishin-kai Medical Corporation has five direct reading rooms. All of them are equipped with wired LAN for the exclusive use of the client. Support for remote SDV and remote audit Heishin-kai’s facilities also support remote direct viewing and remote audits. |
| After completion of clinical trials | Patient Centricity activities In line with our Patient Centricity initiative, we inform our patients of the drug information assigned to them in the trials in which they have participated. Support for PMDA and FDA investigations and extensive experience All of the sites where InCROM provides clinical trial support are subject to PMDA and FDA site inspections about once a year. We use our experience to prepare for these investigations from the moment they are decided. We have received high evaluations in all of our field investigations. |