Services

Support of Clinical development (Drug /
Medical Device / Regenerative Medicines)

Research and development support in pursuit of flexibility

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We pursue flexibility based on our track record in a wide range of fields such as oncology, central nervous system, regenerative medicine, gene therapy, SaMD/DTx, etc., and provide speedy, high-quality services through multifaceted consideration and proposals based on filed information.

Drug development consulting for Bio startups

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At SRD, we work closely with bio startups, sometimes even forming capital partnerships, to advance pharmaceutical development in tandem. Tailoring our services to clients needs, we provide support for all stages of development, from drafting business plans and preclinical activities (such as development strategy formulation, planning of non-clinical trials, manufacturing plan for investigational drugs, and consultations with PMDA) to clinical development and regulatory submissions.

01. Main service contents

  • • Drug development Consultant
  • • Monitoring
  • • Data management / Statistical analysis
  • • Medical Writing
  • • Safety management / support
  • • Audit
  • • Elaboration of application documents for approval
  • • Quality control
  • • Support of Clinical trial notification
  • • Case registration / Drug allocation
  • • Support of compliance inspection
  • • Clinical trial coordination office(Investigator-Initiated Clinical Trials)
  • • Services of In-Country Clinical Caretaker

02. Flow of Development work

Flow of Development work

03. Monitor

Aiming to become establish a partnership
Three components of Monitoring service

Our monitoring service components of collect information as well as speed, quality.
We aim to become establish a partnership with client by collecting feedback from medical profession about development products, and we provide with information that will help guide their subsequent development strategies.

Quality

Professional knowledge through systematic training program

Annual GCP test

Training: Adapting to the latest regulations

Speed

Enrollment of subjects in the short time

Appropriate and flexible response to issues

Collect Information

Collect information from medical profession about development products

Prompt share of events that occur at a site with project members including the client

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