ロゴ：Bell System24

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Clinical Study Support (Case Registration and Allocation，IWRS，and DCT Service)

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  4. Clinical Study Support (Case Registration and Allocation，IWRS，and DCT Service)

We are offering cumulatively over thousands of clinical case registration，drug allocation services，knowledge of IWRS designs corresponding to a wide range of study designs since its start in 1986，and supporting sponsors' activities for patient centralization through our attempt to expand new services for the popularization of DCT (Decentralized Clinical Trial) with its growing attention in Japan.

Do you have any issues like this?

  • Issue1

    Outsource the design of the best supply management logics fit for the purposes and number limit of pharmaceuticals.

  • Issue2

    optimization of managing the supply chain from manufacturing through allocation to delivery and collection.

  • Issue3

    Preparation and examinee follow-up to pursue DCT

Service overview

We offer various types of services，from basic knowledge such as IWRS，supply management，design of subject allocation，emergency key management，to short-term setup and several others aiming for DCT.

POINT1 eClinical Solutions

Our expertise of clinical case examination and various designs of subject allocation over 35 years offers solutions for both conventional knowledge of design specifications to minimize clients' burden of instruction tasks and multi-national clinical trials with our methods of specification studies，short-term system setup，operational managements，data alignment with external solutions (i.e.，EDC) and warehouse or shipping companies，and variety of default functions of Clinical One RTSM.

POINT2 Lifecycle Investigational New Drug Management

We offer centralized management of a set of processes from manufacturing through allocation to delivery and collection to contribute to seamless alignment of quality management under GMP and GCP，reduced burdens on sponsors，and work efficiency.

POINT3 DCT Solutions

We offer services focusing on subject support such as providing clinical trial information，recruitment support，test subject device loan (ePRO)，delivery of Investigational New Drug (DTP)，home nursing support，eConsent，and telemedicine support，to aim at popularization of DCT in Japan through direct approach to subjects with our knowledges of medical contact center，and alignments with external partners.

Usage Flow (Clinical Case Registration)

  • Design of Clinical Case Registraction Center

    Design operating procedures based on protocols and provided information materials for medical institutions alike，for implementation consultant of center structures matching each allocation methods.

  • Construction of Clinical Case Center

    Build a protocol-based clinical case registration support system

  • Reaffirmation of Adequacy for Protocols

    Check contract information of medical institutions，enrollment of doctor information，reaffirmation of adequacy of protocols，omissions of description inventory，and mismatch reports.

  • Adequacy Determination and Subject Allocation

    Determine protocol-based adequacy and set subject allocation.

  • Notification and Tracking of Case Registration Results

    Notify medical institutions and clients of results via Email or on website and track the condition of clinical case registration.

FAQs about solutions and services

  • Quality and information security initiatives

    Our pharmaceutical-related business has established a quality management system based on the concept of ISO 9001，the international standard for quality management systems，and was one of the first in the CRO industry to obtain ISO 9001 certification in 2001. Even after obtaining certification，we have continued to pursue “reliability” for more than 20 years，and we have a proven track record of success. In addition，considering the importance of the information we handle，we also thoroughly implement information security management and personal information protection under our information security policy and personal information protection policy，and have obtained ISO 27001 certification. We are committed to continuous review and improvement in order to provide reliable and appropriate quality at all times. See here (https://solution.bell.co.jp/en/solution/medical/Information) for details.

  • Do you offer eClinical solutions?

    Bellsystem24 is the only company affiliating with Oracle in Japan to offer services in Clinical One RTSM: digitalize operational processes，significantly shortening the term of construction of design in clinical trials under the clients' self control of its substantial designs and management functions. It also forms a total integrated platform that enables us to centralize management of clinical trials and the advancement of eClinical for digitalized and optimized clinical trials. (Reference for more detailed information about Clinical One RTSM: https://www.oracle.com/jp/industries/life-sciences/clinical-research/clinical-one-randomization-supplies-management）

  • What is your specific DCT solution to offer?

    We offer one-stop operations，including provision for procurement controls of devices and communication lines such as smartphones and tablets for use in eConsent，and helpdesk for subject support.

  • What is Lifecycle Investigational New Drug Management?

    Our support covers both sides of the CMO and CRO: design of pharmaceutical formulation and packaging，manufacture of investigational new drugs，and the primary packaging of drugs on the CMO side，and allocation of investigational new drugs，provision，operation，and management of general supplies，and management of venders in warehouses or shipping in the CRO side. We offer both partial services and total solutions in collaboration with CMO.

  • What do you offer for BCP in clinical trial?

    We offer safety confirmation systems for both subjects and staff in medical institutions in the event of natural disasters to alleviate burdens on the sponsor side，including staff of medical institutions and CRO to determine matters such as whether to continue clinical trials.

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