Clinical Trial Planning and PMDA Consultation Support

About Us

We support clinical trial planning and the creation of PMDA related consultation documents contents.

We also support development planning for pharmaceuticals and regenerative medical products, individual clinical trial planning, PMDA consulting services (preliminary interview, face-to-face advice, RS consultation, etc.), and clinical trial consultation materials creation.

EPS Features

Clinical Trial Planning (Designing and consulting services)

Our experienced consultants provide proposals for clinical data packages and clinical trial plans, and full operation support, including PMDA compliance.

Expertise

In addition to our extensive expertise on clinical trial operations for a variety of disease areas, we are also experienced in PMDA consultation and clinical trial planning consulting services.

Regenerative Medical Products

With extensive experience in clinical trial operations and clinical trial planning support related to the development of regenerative medical products, we offer strategic clinical development planning support and Preclinical Development consultation, such as Quality and Safety consultation.

Services

Drug Development Planning and PMDA Consultation Support Services

Full support and strategic planning for PMDA Consultation and clinical trial planning regarding the development of pharmaceuticals and regenerative medicine products.

Clinical Planning and Consultation for:

  • Development strategy, Clinical Data Package, etc.
  • Clinical trial plan formulation, statistical analysis.
  • Consultation with regulatory authorities regarding the entire development process (orphan drugs　designation, etc.).

PMDA Consultation Support on:

  • Compiling the main consultation points.
  • Procedural materials and study records creation and participation in PDMA consultations.
  • Preliminary materials creation (study protocols, ICFs, etc.).

Regenerative Medicine Products

  • Full PMDA consultation support from Quality and Safety consultation to clinical trial protocol consultation.
  • Formulation of clinical trial implementation plan and statistical analysis consultation.
  • Total management support, including clinical trial operations.