MEDISCIENCE PLANNING INC.

Service

Support from every aspect sustain our growth.

We meet your needs with one of our service or with combination of several services. In all aspects, you can expect our high quality services by our well educated and experienced staff in timely manner.

  • Consulting / Regulatory Services

    Consulting / Regulatory Services

    • Planning of pharmaceuticals development strategies and medical device
    • Support for PMDA consultations / liaison with regulatory authorities
    • Preparation of New Drug Applications / Re-examination Applications
    • Preparation of Clinical Trial Notifications (CTN)
  • In-Country Clinical Caretaker

    In-Country Clinical Caretaker

    • Total management of CTN related services
    • Pharmacovigilance related services



  • Project Management

    Project Management

    • Overall project management (status, quality, and budget)
    • Cross-functional coordination
    • Primary contact with clients
    • Information sharing / update with clients
    • Regular meetings (issue-focused proposals and CAPA implementation)
    • Vendor management
  • Multinational Study

    Multinational Study

    • Feasibility study
    • Project management (incl primary contact with overseas clients and CROs)
    • Monitoring (Phase I~IV)
    • Medical monitoring
    • Vendor management
    • Translation / printing of clinical dossiers
  • Clinical Pharmacology

    Clinical Pharmacology

    • Feasibility study of clinical pharmacology units
    • Selection/survey/validation support regarding laboratories for measurement of drug concentration
    • Selection of medical institutions and investigators
    • Request of clinical study conduct to medical institutions and contract conclusion
    • Collection of Case Report Form (CRF)
    • Direct Access (SDV)
    • Study closeout
    • Quality Control
  • Monitoring Services

    Monitoring Services

    • Feasibility Study
    • Selection of medical institutions and investigators
    • Request of clinical study conduct to medical institutions and contract conclusion
    • Collection of Case Report Form (CRF)
    • Direct Access (SDV)
    • Study closeout
    • Quality control
    • Holding various conferences
    • Support to hold an Independent Data Monitoring Committee (IDMC)
    • Vendor management
    • Unblinded Monitoring
  • Data Management

    Data Management

    • Preparation of DM plan / procedures
    • Preparation of DM reports
    • Preparation of CRFs (draft) and CRF completion guidelines
    • Database design
    • Data cleaning (logical check and manual check)
    • CRF (draft) design
    • User training
    • Query management (preparation, issue, and resolution)
    • Coding (draft) of safety information and drugs
  • Biostatistics

    Biostatistics

    • Preparation for Statistical Analysis Plan (SAP) / procedures
    • SAS programming
    • Preparation of dataset for analysis
    • Implementation of interim analysis
    • Preparation for analysis reports
    • Material preparation for Case Review Meeting
  • Post Marketing Surveillance

    Post Marketing Surveillance

    • Database design
    • Entry into database
    • Data check and query preparation
    • Data entry of query results
    • Coding
    • Reconciliation
    • Statistical analysis / summary preparation
    • Periodic safety reports (draft)
    • Medical Imaging Analysis
  • Pharmacovigilance

    Pharmacovigilance

    • Preparation of preliminary evaluation of adverse drug reactions (draft) (domestic/foreign individual cases, literatures, and research reports)
    • Preparation of reports (SGML files) regarding information required to be reported to PMDA
    • Preparation of periodic safety reports (draft) and re-examination applications (draft)
    • Data entry of safety information into database and database management
    • Consulting services related to safety information
  • Clinical IT Solutions

    Clinical IT Solutions

    • Database design and operation of Electric Data Capture (EDC) (e-CRF design, EDC setup, CSV, and user training)


  • Medical Writing

    Medical Writing

    • Preparation of Investigator's Brochure (draft)
    • Preparation of Protocol (draft)
    • Preparation of Informed Consent Form (ICF) (draft)
    • Preparation of Clinical Study Report (CSR) (draft)
    • Preparation of Common Technical Document (CTD) (draft)
    • Publication support
    • Translations and Quality Check of the above documents
  • IP Management/Storage/Custom Clearance

    IP Management/Storage/Custom Clearance

    • Management, storage, delivery, and collection of investigational products
    • Preparation of relevant procedures
    • Custom clearance


  • Medical Imaging Analysis (Imaging CRO)

    Medical Imaging Analysis (Imaging CRO)

    • The following modalities are available
      X-ray,CT, MRI, PET, SPECT, Cardiac catheterization,Angiography, Ultrasound, Bone densitometry, X-ray TV etc.
    • Provision of image acquisition guidelines
    • CRA training
    • Support for collection of imaging data
    • Image analysis (imaging core laboratory) and evaluation
    • Investigation, selection and contract conclusion of image-reading doctors
    • Operation / support for Diagnostic Radiology Central Review (DRCR) committee
    • DRCR system construction
    • Preparation for DRCR result reports and data delivery (CSV file etc.)
    • Support for Phantom studies
    • Medical diagnostic imaging consulting
  • Patient'sRegistration / Enrollment Services

    Patient'sRegistration / Enrollment Services

    • Patient registration (receipt by Fax)
    • Eligibility assessment
    • Allocation of Investigational Products (including dynamic allocation)


  • Quality Assurance

    Quality Assurance

    • Audits for awarded clinical trial related services
    • Audits for medical institutions for clinical trials
    • Audits for clinical systems


  • CRA and Other Supply / Dispatch

    CRA and Other Supply / Dispatch

    • Specified worker dispatch:
    • CRA
    • Quality Control
    • Data Management
    • Pharmacovigilance
  • Interventional / Non-Interventional Study Observational Study

    Interventional / Non-Interventional Study Observational Study

    • Secretariat services
    • Patient's registration
    • Monitoring
    • Database design and operation of Electric Data Capture (EDC) / Data Management
    • Summary preparation
    • Publication support
    • Support for holding conferences
    • Medical Imaging Analysis
  • Food Development

    Food Development

    • Total Support for development of food for specified health use/health food
    • Protocol preparation
    • Selection of medical institutions and laboratories
    • Monitoring
    • DM/Summary preparation
    • Support for preparation of CSR / publication
  • CDISC-related Services

    CDISC-related Services

    • CRF design (CDASH)、eCRF design (CDASH)
    • SDTM tasks
      •Dataset specifications
      •Programming
      •SDTM datasets,Define.xml package generation
    • ADaM tasks
      •Dataset specifications
      •Programming
      •ADaM datasets ,Define.xml package generation
    • Analysis results(Programming、TFLs generation)
  • Risk-Based Monitoring Solution Services

    Risk-Based Monitoring Solution Services

    • Risk Identification
    • •Program level/ Protocol level/ Site level
    • Proposal and Preparation for Risk Assessment Plan
      •Monitoring/ Centralized monitoring/ Medical monitoring
      •Data management / Statistical analysis
      •Training
    • Risk Assessment
      •Site implementation risk by On-site/ Off-site monitoring
      •Timely Visualization/Analysis of EDC data
    • Centralized Monitoring Services
  • Regenerative Medicines Support

    Regenerative Medicines Support

    • Consulting / Regulatory Services
    • Project Management
    • Monitoring Services
    • Data Management
    • Biostatistics
    • Post Marketing Surveillance
    • Pharmacovigilance
    • Medical Writing
    • Quality Assurance
    • Medical Imaging Analysis
TOP