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Clinical_development / CRA teams
Inquiries of principal investigators and clinical trial sites
The success of any clinical trial depends on the accurate assignment of principal investigators. This is mostly because the number of patients participating in a trial is affected by the principal investigators’ ability. At Clio Science Inc., we visit the assigned doctors and explain the investigating drug thoroughly. We only make our final investigator selection decisions after careful consideration in order to assure the quality of clinical trials.
Making contracts with clinical trial sites
Making contracts with clinical trail sites requires a large amount of paper work. We prepare them accurately within the allocated timeframe. Contracts will be made after the approval of the IRB, and receiving a notice letter from the trail site.
Delivery and collection of drugs
Following the completion of a contract, we deliver the required documents, including information of the investigating drug, conservation methods, management and precautions to the investigating drug administrator and explain them in full detail.At the end of a trial, we collect all remaining drugs, check their numbers and compliance with the administration table.
Monitoring
Our highly qualified specialists will proceed monitoring to their best quality following GCP (Good Clinical Practice), SOP (Standard Operating Procedure) and Protocol. The monitors at Clio Science Inc. are equipped with expertise, through continuous training programs and self study. “To get good drugs into the hands of patients quickly.” We pledge to make a great effort to fulfill this objective, and to provide a trustworthy service to the pharmaceutical company and medical institutions.
Collecting and checking of Case Report Forms (CRF)
We ensure that there is no discrepancy between the source material and the CRF, nor any erroneously omit ions before collecting the CRF. Those CRFs that needs correction are handled quickly and precisely.At Clio Science Inc., we accomplish our work with the highest morality and responsibility.
Source Document (Data) Verification (SDV)
We verify the compliance of all source material, including medical charts, examination outcomes etc., and of the CRFs. To enhance the reliability of the data, we confirm all uncertain events with the doctors or cooperators.
We check to confirm whether the essential documents are being kept by the clinical trial sites and to make sure clinical trials are operating appropriately, in order to protect the patients’ safety.
We check to confirm whether the essential documents are being kept by the clinical trial sites and to make sure clinical trials are operating appropriately, in order to protect the patients’ safety.
Termination procedure of clinical trials
At the end of a clinical trial, collecting outstanding documents and drugs, and verifying their compliance is necessary. We also manage the termination procedure and ensure that all essential documents are archived.
Our Quality Control Office operates as an assurance system.
We have permanent QC staffs to guarantee the quality of all clinical trials. The QC staffs check whether the clinical trial is proceeding in compliance to the Protocol, GCP, SOP and regulations.
We have permanent QC staffs to guarantee the quality of all clinical trials. The QC staffs check whether the clinical trial is proceeding in compliance to the Protocol, GCP, SOP and regulations.
Verification of essential documents
Essential documents are made on every level of a clinical trial (before the trial begins, during the trial and at the termination of the clinical trial). Our QC staffs verify all documentation for perfection.
Verification of monitoring reports
In order to ensure the quality of monitoring reports, which CRAs have developed, the QC staffs or the Clinical Team Leader (CTL) verify the reports to collect an accurate database.
Development of Standard Operating Procedure (SOP) for quality control
Creating the SOP for quality control and correcting it whenever the GCP has been revised or edited are also important work for the QC staffs.
Verification of clinical trial related activities
Throughout a clinical trial, documents are created for each trial site, pharmaceutical companies, IRBs and principal investigators. Our QC staffs ensure that every procedure closely follows the GCP and trial SOP to maintain the quality and reliability of the clinical trial.
Verification of evaluated work in Safety Information
The trusted QC staffs verify whether (serious) adverse events are adequately graded, and also accommodate mistakes or blanks that may appear in a CRF or source material.
At the same time, QC staffs ensure that the Safety Information is infallibly transmitted to the principal investigators and IRB.
At the same time, QC staffs ensure that the Safety Information is infallibly transmitted to the principal investigators and IRB.
Storage management of data
Our QC staffs file all the essential documents such as contracts, CRF and IRB related documents for each clinical trial and site throughout the stated period. We also strictly retain classified materials, and carefully manage it to sustain the trail’s quality and reliability.
Medical device related service
The steps made for the use of medical devices, require a process that follows the Drug Legislation. There is a need for experience and knowledge in the usage and application procedure of medical devices. Clio Science Inc. provides our highly educated consultants to advance the quality and safety of the product, and build a company structure based on GQP, GVP, and QMS.
Consulting
Supporting clinical developments
Supporting the development of applications for approval
Supporting the correspondence to the regulatory authority
Developing strategies for the application of medical insurance and supporting the document preparations
Supporting the development of application form of business license
Development of GMP, GQP, GVP, QMS related documents
Consultation related to designated manufacturing
Postmarketing studies
Consulting for changes made in business content due to the amendment of the Drug Legislation
Translation of manuals, technical information etc.
Medical device related service
The steps made for the use of medical devices, require a process that follows the Drug Legislation. There is a need for experience and knowledge in the usage and application procedure of medical devices. Clio Science Inc. provides our highly educated consultants to advance the quality and safety of the product, and build a company structure based on GQP, GVP, and QMS.
Consulting
Supporting clinical developments
Supporting the development of applications for approval
Supporting the correspondence to the regulatory authority
Developing strategies for the application of medical insurance and supporting the document preparations
Supporting the development of application form of business license
Development of GMP, GQP, GVP, QMS related documents
Consultation related to designated manufacturing
Postmarketing studies
Consulting for changes made in business content due to the amendment of the Drug Legislation
Translation of manuals, technical information etc.
