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Our Services

CONSULTING BUSINESS OPERATION BPO IT SOLUTION

CONSULTING

Let our consultants solve your business challenges.

Our consultants, specialized in the pharmaceutical industry, are here to guide and support you in formulating and executing strategies, as well as optimizing and standardizing your operations. We don't just identify challenges and propose solutions; we stay by your side throughout the implementation of each measure, taking full responsibility until results are achieved.

Clinical Development
  • Development Strategy, Regulatory Consultations, Orphan Drug Applications
  • Trial Protocol Development, Sample Size Design, Analysis Plan Development
  • Application Document Preparation, Response to Regulatory Inquiries
Post-Marketing Surveillance
  • Marketing Preparation Support from the Application Period (RMP Formulation, PMS Strategy and Feasibility Assessment)
  • Assistance in Creating PMS Implementation Plans, Examining Investigation Items, and Developing Analysis Plans
  • Consulting for the Implementation of EDC (Electronic Data Capture) and Progress Management Systems, etc.
PV (Pharmacovigilance)
  • Consulting on Safety Management during Development
  • Establishment of Post-Marketing Safety Management Systems, Development of SOPs and Manuals
  • Consulting for the Implementation of Safety Databases and More
IT
  • Formulation of System High-Level Designs by Business Phase and Business Domain
  • User Requirement Definition, RFP Creation, Vendor Selection, PMO Activities
  • CIO Delegation of Duties, Creation of IT SOPs and Policies, and More

BUSINESS OPERATION

Have our industry experts support your operations.

Our skillful and experienced team will provide comprehensive support to meet your business needs. Through flexibility and ability to provide a broad range of on-site support, we aim to reduce your workload and enhance your operations.

Data Management
  • Creation of Data Management Plans and Procedures
  • Drafting of Case Report Forms and Database Specifications
  • Data Cleaning, Coding, etc.
Statistical Analysis
  • Creation of Clinical Trial Implementation Plans, Analysis Plans, and Summary Reports
  • Development of Chart and Table Layouts and other specifications related to analysis
  • Quality management of deliverables from Contract Research Organizations (CRO) and more.
PV (Pharmacovigilance)
  • Case Processing, Case Assessment, Reporting Activities
  • Support for Case Management Tasks, Quality Management
  • Periodic Reporting, Overall Responsible Person and Safety Management Responsible Person Reports, etc.
IT
  • Project Management, Vendor Control
  • Development of Systemization Plans, Creation of RFPs, Requirement Definition, Design, Development, and Operation Formulation
  • Creation of CSV (Validation) Documents, etc.

BPO

We support your clinical trial operations and more.

We provide support ranging from the initiation to exection of clinical trials and Post-Marketing Surveillance.

Clinical Trials
  • Patient Enrollment, Randomization
  • Data Management (Creation of Data Review Specifications, Data Cleaning, Coding, Data Locking, SDTM Creation, etc.)
  • Statistical Analysis (Creation of Analysis Plans, ADaM Creation, Generation of Statistical Analysis Reports, etc.)
  • EDC (Electronic Data Capture) Development
Post-Marketing Surveillance
  • Monitoring Support
  • Facility Contracts (Facility Information Management, Contract Document Creation, Payment Management, etc.)
  • Patient Enrollment (Enrollment Processing, Confirmation of Complete Enrollment, etc.)
  • Data Management (Creation of Data Review Specifications, Data Entry, Reconciliation, Coding, Data Locking, etc.)
  • Statistical Analysis (Creation of Analysis Plans, Development of Analysis Datasets, Creation of Analysis Reports, etc.)
  • Medical Writing (Creation of Periodic Safety Reports, Preparation of Re-submission Documents, etc.)
  • EDC (Electronic Data Capture) and Progress Management System Development

IT SOLUTION

Maximize operational efficiency through system optimization

We provide support for the introduction of myriad systems in clinical development, Post-Marketing Surveillance, and other areas, including outsourcing development, maintenance, and operations.

System Development
  • Development of EDC (Electronic Data Capture) and CDMS (Clinical Data Management System)
  • Development of Progress Management Systems
  • Implementation of Safety Information Systems
  • Development of Business Management Systems and BI Reporting Systems utilizing Microsoft 365
  • Development of Business Efficiency Tools using VBA, Python, etc.
System Operation
  • Operation and Management of EDC (Electronic Data Capture) and CDMS (Clinical Data Management System)
  • Operation and Management of Progress Management Systems
  • Managed Services for Safety Information Systems
  • Operation and Management of Commercial Data Platforms
Implementation of Overseas Solutions
  • Implementation and Management Services for Track and Trace and other Serialization Systems
  • Implementation of Safety Information Collection Systems
  • Implementation of Overseas EDC Systems
  • Safety Data Reporting Systems