Data Management (PMS)

About Us

Being one of the largest organizations in Japan with extensive expertise, we can propose the best plan for you.

Data management is the process of creating a database to collect data from medical institutions, organizing and checking the collected data, and deriving accurate data that can withstand statistical analysis.

EPS features

Customer Burden Reduction

• We participate in all stages of the investigation process and contribute to improving the overall quality and speed of the investigation by foreseeing risks that may arise in later stages and acting in advance.
• We will contribute to the early completion of the study by collaborating with pharmaceutical companies, medical representatives, and medical institutions.
• We also manage other players involved in the post-marketing surveillance such as system vendors.

Synergy Improvement Between Departments

• By collaborating with other departments and implementing a cycle of planning, execution, reflection, evaluation, and correction, we can contribute to the early termination of the surveillance and quality improvement.
  • Collaboration with post-marketing surveillance monitors
    • Preliminary arrangements: Cooperatively prepare documents for sites and conduct preliminary study sessions.
    • Surveillance assistance: Prompt collaboration when suspicions arise, frequent re-surveillance analysis and cycle improvement assistance.
  •  Collaboration with other departments related to data science such as statistical analysis and medical writing.
    • Preliminary arrangements: Share and compare information that might need to be resurveyed or updated.
    • Periodic safety report: Prior sharing of irregular data and prompt inter-departmental inquiries when questions arise.
    • Periodic safety report review: Share any doubts that arise in retrospect and make improvements, so the same doubts do not arise in the future.

Multifaceted Support with Abundant Resources

• With many resources and experience gained from a wide variety of surveillance start-up and operational projects we can support our clients from various perspectives.
  • Extensive surveillance experience: 150 surveillance projects in the past 5 years
  • Broad scope of work: registration and survey form design, data review and maintenance for conformity assessment. compliance inspections attendance. (See service description below.)
  • Substantial experience: more than half of our 100+ data managers have 5+ years of experience in data management.

Services

• Registration and surveillance forms design
• Creation of [How to fill out survey forms] instruction manualsvCreation of EDC (Electronic Data Capture) operation manuals and conduction of EDC trainingvCreation of specifications for logical and manual checks
• Creation of registration system, data management system, and EDC system and implementation of system validation
• ePRO (electronic Patient Reported Outcome) implementation support and device rental
• System vendor managementvCall center set up
• Conduct EDC operation and resurvey content workshops for medical representatives
• Shipping of survey materials and surveillance forms issuance
• Data entry and correction
• Coding of adverse events, complications, drugs, etc.
• Logical and manual checks implementation
• Adverse events matching
• Preparation and dispatching re-surveillance materials
• Early fixation of surveillance forms
  • Provide explanation and other support for re-surveillance and assistance to fix surveillance forms
• Case studies materials preparation
• Database locking
• Dataset creation
• Self-inspection
• Document storage
• Reexamination application support
  • Confirmation of pre-application data
  • Revision of forms and provision of flowcharts, etc.
• Compliance inspections attendance

Supported EDS Systems

With our extensive experience in EDC implementation, construction, and operation, we can also assist you in developing workflows and standard operating procedures (SOPs) for new EDC implementations.

• PostMaNet
• Rave®, RaveEDC®
• Viedoc™
• Datatrak Enterprise Cloud