Services
Support of Clinical development (Drug /
Medical Device / Regenerative Medicines)
Research and development support in pursuit of flexibility
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
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
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
