Service

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.

Pick up any from
the diverse lineup of services

In the rapidly changing era when clinical trials have been more and more international and diverse, you can pick up any from the diverse lineup of services MPI provides in the development of pharmaceuticals, medical devices, foods, etc. and a variety of human resources with abundant expertise and experiences MPI supplies.

Contact

CONTACT US

Consulting/
Regulatory Services

  • ・Regulatory Consulting Services

    1. ー Regulatory strategies for the development of new pharmaceuticals, etc. and consultation of local regulations and ordinances

    2. ー Planning of regulatory strategies for the development of new pharmaceuticals, etc.

  • ・Conduct of/support to PMDA Consultations

    1. ー Strategic planning for PMDA Consultations on the development of pharmaceuticals, etc.

    2. ー Preparation/submission of PMDA consultation documents on pharmaceuticals, etc., support to the client’s response to PMDA’s queries, and liaison with the regulatory authorities

  • ・Support to CTD preparation

    1. ー Preparation of/support to preparation of documents Regulatory Affairs is in charge (Module 1, etc.) in CTD

  • ・Clinical Trial Notifications (CTN)

    1. ー Preparation of/support to CTN and related notifications, and their submission as well as management

  • ・In-Country Clinical Caretaker (ICCC) - Regulatory services

    1. ー CTNs for ICCC trials and liaison, etc. with the regulatory authorities

  • ・Support to apply for designation as pharmaceuticals with cutting-edge technologies and orphan drugs

    1. ー Preparation of/support to application dossiers, support to application and post-application examination

  • ・Consultation of various regulatory procedures, review result report (draft), confirmation of the reasons for their prioritized review, review of the dossiers, etc.

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In-Country Clinical Caretaker

  • ・Total management of CTN-related services

  • ・Pharmacovigilance-related services

    1. ー discussion and assessment, report to the regulatory authorities, report/escalation to the overseas clients or the local liaisons

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Project Management

  • ・Overall project management

    1. ー progress status update, quality, and budget management

  • ・Cross-functional coordination

  • ・Primary contact with clients

  • ・Information sharing/update with clients

  • ・Regular meetings (issue-focused proposals and CAPA implementation)

  • ・Vendor management

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Clinical Pharmacology
(Phase I and BE trials)

  • ・Feasibility study of clinical pharmacology units

  • ・Selection/survey/validation support regarding laboratories for drug concentration measurement

  • ・Preparation of various procedures and manuals

  • ・Selection/survey of clinical pharmacology units and investigators

  • ・Request of clinical study conduct to the units and CTA execution

  • ・Direct Access (SDV)

  • ・Study closeout procedures

  • ・Quality control

  • ・Vendor management

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Monitoring Services
(Phase II / III / IV)

  • ・Feasibility study

  • ・Preparation of various procedures and manuals

  • ・Selection/survey of medical institutions and investigators

  • ・Request of clinical study conduct to the medical institutions and CTA execution

  • ・Collection of Case Report Form (CRF)

  • ・Direct Access (SDV)

  • ・Provision/collection of safety information

  • ・Study closeout procedures

  • ・Quality control

  • ・Holding various conferences

  • ・Support to hold an Independent Data Monitoring Committee (IDMC)

  • ・Vendor management

  • ・Response to Document Conformity Inspections

  • ・Unblinded Monitoring

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Clinical IT Solutions

  • ・Support to subject enrollment and allocation to cohorts

  • ・Design and implementation of ePRO

  • ・Support to distribution of ePRO devices

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Data Management

  • ・Preparation of DM plan/procedures

  • ・Preparation of DM reports

  • ・Design and implementation of EDC

    1. ー eCRF design, EDC setup, CSV, user training, account management

  • ・Data cleaning

    1. ー logical check and manual check

  • ・Support to design and implementation of CRF

  • ・Query management

    1. ー preparation, issue, and resolution

  • ・Preparation of various table/lists for support

  • ・Support to EDC management sheets

  • ・Coding of safety information and drugs

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Biostatistics

  • ・Preparation for Statistical Analysis Plans (SAP) / procedures

  • ・Preparation of tables and listing templates

  • ・Preparation of statistical program specification and SAS programming

  • ・Preparation of dataset for analysis

  • ・Implementation of analysis

  • ・Preparation for Statistical Analysis Reports (SAR)

  • ・Preparation of documents used at Case Review Meetings

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CDISC-related Services

  • ・Design of CDASH-compliant CRF/eCRF

  • ・SDTM data conversion

    1. ー Dataset specifications (mapping)

    2. ー Programming

    3. ー Preparation of SDRG, Define.xml, and a-CRF

  • ・ADaM data conversion

    1. ー Dataset specifications

    2. ー Programming

    3. ー Preparation of ADRG and Define.xml

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Medical Writing

  • ・Preparation of Investigator's Brochure (draft)

  • ・Preparation of Protocol (draft)

  • ・Preparation of Patient Information and Informed Consent Form (ICF) (draft)

  • ・Preparation of Clinical Study Report (CSR) (draft)

  • ・Preparation of Common Technical Document (CTD) (draft)

    1. ー Edit/compilation of eCTD v4 is acceptable upon subcontracting agreement

  • ・Publication support

  • ・Translations and Quality Check of the above documents

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Pharmacovigilance

  • ・Collection of safety information from (domestic and overseas) clinical trials and PMS, data entry into the database, preparation of preliminary evaluation (draft), re-examination (draft), Adverse Drug Reactions and Infection Case Reports/XML files, and Overseas Reports (draft)

  • ・Literatures and research reports, preliminary evaluation (draft) of Safety Measures Taken Abroad Reports, and preparation of reports to PMDA (draft)

  • ・Preparation of Periodic Safety Update Reports (draft) and Re-examination application documents (draft)

  • ・Consulting services related to safety information

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Medical Imaging Analysis
(Imaging CRO)

  • ・The following modalities are available

    1. ー X-ray, CT, MRI, PET, SPECT, Ultrasound, Cardiac catheterization, Angiography, Bone densitometry, X-ray television, Endoscope, etc.

  • ・Provision of Image acquisition guidelines and Diagnostic Radiology Central Review (DRCR) procedures

  • ・CRA training

  • ・Support to collect imaging data

  • ・Image analysis (imaging core laboratory) and evaluation

  • ・Survey/selection of and contract execution with image-reading doctors

  • ・Operation of/support to DRCR committee

  • ・Build-up of DRCR system

  • ・Preparation for DRCR result reports and data delivery (CSV file, etc.)

  • ・Support to PET Phantom studies and data analysis

  • ・Artificial Intelligence (AI) qualification tests

  • ・Blinding DICOM data

  • ・Medical diagnostic imaging consulting

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IP Management/Storage/Custom Clearance

  • ・Management, storage, delivery, and collection of investigational products

  • ・Preparation of the relevant procedures

  • ・Custom clearance

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Quality Assurance Services

  • ・Audit on MPI teams working for the awarded clinical trials

  • ・Audit at medical institutions working for the awarded clinical trials

  • ・Audit on the systems

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Support for Regulatory Affairs

Characteristics of the pharmaceutical application support service of Mediscience Planning

Based on our extensive experience of over 30 years, we support the rational and prompt development of a plan for obtaining approval.
・Specialists in fields such as pharmacy, chemistry, biochemistry, and metal engineering provide support.

Pharmaceutical application support services
Medical devices and in-vitro diagnostics

  • ・Support and consulting for preparation of approval (certification) applications, notifications, etc.

  • ・Support for preparation of application for marketing license, registration for manufacturers, and application for registration of foreign manufacturers

  • ・Support for preparation of IVD approval (certification) applications

  • ・Support for the preparation of approval applications for veterinary medical devices

  • ・Consulting on QMS and GVP

  • ・Consulting on applications for insurance coverage

  • ・Consultation support for the Pharmaceuticals and Medical Devices Agency (PMDA) and other authorities

  • ・Support for formulation of pharmaceutical strategy

  • ・In order to support the entry of overseas medical device manufacturers and in-vitro diagnostics manufacturers into the domestic market, Mediscience Planning has obtained a First-class marketing license for medical device (License No. 13B1X10366) and a marketing license for in-vitro diagnostics (License No. 13E1X00036).

Pharmaceutical products

  • ・Support for preparation of various application forms (FD input, attached documents, etc.)

  • ・QC operations for documents related to various applications

  • ・Support for CTD creation (related to CMC)

  • ・Support for preparation of application for accreditation of foreign manufacturers

  • ・Support for preparation of periodic GMP compliance inspection applications for pharmaceutical products

Actual support for obtaining approval (certification)
Medical devices

  • ・Medical device program

    1. ー Boron neutron supplementation planning program

    2. ー External Fixation Planning Support Program

    3. ー Orthodontic support program

    4. ー Program for MR machine workstation

    5. ー Program for the X-ray imaging system workstation

    6. ー Programs for fundus cameras

    7. ー Program for general-purpose diagnostic imaging system workstation

    ・Medical device (approved Class IV)

    1. ー Intravascular catheter for central circulatory guidance

    2. ー Catheter introducer kit for heart

    3. ー Balloon dilated angioplasty catheter

    4. ー Collagen-containing topical hemostatic agent

    5. ー Prosthesis for promoting central circulatory system intravascular embolization

    6. ー Automatic implantable cardiac defibrillator

    7. ー Implanted biventricular pacing pulse generator with defibrillation

    8. ー Aortic stent graft

    9. ー Bovine pericardial patch

    ・Medical devices (approval and certification class III)

    1. ー Radiopharmaceutical synthesizer

    2. ー Submucosal infusion material for endoscopy

    3. ー Cochlear implants

    4. ー Continuous automatic positive airway pressure unit

    5. ー Hip femoral component

    6. ー Linear accelerator system

    7. ー Dental implant abutment

    8. ー Fixed-bone hearing aid

    9. ー Neurosurgical navigation unit

    ・Medical Devices (Class II Approval)

    1. ー Evoked response meter

    2. ー Electroencephalograph

    3. ー General-purpose ultrasound diagnostic imaging equipment

    4. ー Injectors for drugs and vaccines

    5. ー Digital impression taking device

    ・Medical equipment (class II certification)

    1. ー Automated digital blood pressure monitor

    2. ー Ophthalmic camera

    3. ー Sleep Assessment

    4. ー Pure tone audiometer

    5. ー Computed radiograph

    6. ー Arm-type X-ray CT diagnostic equipment

    7. ー High-pressure steam sterilizer for packaging

    8. ー Artificial nose

    9. ー Xenon beam therapy apparatus

    10. ー Orthodontic resin material

    11. ー Ceramics for dental cutting

    ・In vitro diagnostics (approved)

    1. ー Pertussis antigen kit

    2. ー Legionella kit

    3. ー Group A beta-hemolytic streptococcal antigen kit

    4. ー Chlamydial antigen kit

    5. ー Influenza virus kit

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CRA and Other Supply / Dispatch

  • ・CRA

  • ・Quality Control

  • ・Pharmacovigilance

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Multinational Study

  • ・Feasibility study

  • ・Project management

    1. ー incl primary contact with overseas clients and CROs

  • ・Monitoring (Phase I through IV)

  • ・Medical monitoring

  • ・Vendor management

  • ・Translation / printing of clinical dossiers

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Post-Marketing Surveillance

  • ・Design and Implementation of EDC

  • ・Cross-checking the data and issue queries

  • ・Re-evaluation data enter

  • ・Coding

  • ・Case review

  • ・Biostatistics and aggregated data analysis

  • ・Period Safety Update Reports (draft)

  • ・Self-check

  • ・Medical imaging analysis

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Clinical Research

  • ・Clinical Research Office

  • ・Subject enrollment

  • ・Monitoring

  • ・Design and Implementation of EDC, and data management

  • ・Biostatistics

  • ・Literature preparation

  • ・Support to hold the conferences

  • ・Medical imaging analysis

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Medical Device Development

  • ・Regulatory Consulting Services

  • ・Project management

  • ・Feasibility study

  • ・Preparation of CTNs

  • ・Monitoring

  • ・Quality control

  • ・Data management

  • ・Biostatistics

  • ・Pharmacovigilance

  • ・Medical writing

  • ・GCP audit

  • ・Medical imaging analysis

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Regenerative Medicine Development

  • ・Regulatory Consulting Services

  • ・Project management

  • ・Monitoring

  • ・Data management

  • ・Biostatistics

  • ・Post-marketing surveillance

  • ・Pharmacovigilance

  • ・Medical writing

  • ・GCP audit

  • ・Medical imaging analysis

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Software as a Medical Device Development

  • ・Regulatory Consulting / PMDA Consultation

  • ・Project management

  • ・CTN application/response to Japan Registry of Clinical Trials (jRCT)

  • ・Monitoring

  • ・Subject enrollment and assignment to cohorts

  • ・Imaging captured by AI devices (conduct of Quality assessment trial and Image reading trial）

  • ・Data management

  • ・Biostatistical consulting/Biostatistics

  • ・Medical writing

  • ・GCP audit

    1. ー GCP trials, Observational studies, and medical research council ethical guidelines will be conducted to all the services above

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AI and Digital Healthcare

  • ・Consulting/Regulatory services

  • ・Project management

  • ・Support to build up a clinical trial network with the use of AI tools

  • ・Medical Image analysis

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Food Development

  • ・Total Support for development of food for specified health use/health food

  • ・Protocol preparation

  • ・Selection of medical institutions and laboratories

  • ・Monitoring

  • ・Data management / aggregated data analysis

  • ・Support for preparation of CSR / publication

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