Services Available

[ I ]  Medical consulting & advices for development of medial drugs, devices,, clinical studies, quality

        control and medical education 　

A. Consulting

　 1) Medical drug and device relating company strategy for developing new drugs and medical devices.

　 2) Strategic planning and development of medical drugs and devices in Japan and abroad.

　 3) Post-marketing surveillance and the sales strategy of post-market drugs.

　 4)  Designing ,management and assessment of pre-clinical studies.

B. Medical Advisor Affairs

　 1) Supporting for any medical aspect in pharmaceutical businesses.

　 2) Participating in Institutional Review Board and Independent Data-Monitoring Committee.

　 3) Medical negotiations with coordinating investigators and investigators.

　 4) Medical Advice for writing protocol, case report form and informed consent.

　 5) Medical check for investigators brochure and clinical study report.

　 6) Supporting　for monitoring and SDV

　 7) Management of safety information concerned with clinical trials or post-marketing surveillance,

          and medical check of adverse event and reaction to be reported.

C. Supporting in clinical studies

　 1) Monitoring

　 2) Regulatory affairs (NDA)

　 3) Data management and statistic

　 4) Writing of medical documents (drug information summary, protocol, case report form, summary

         study report, medical research papers)

　 5) Source document verification (SDV)

D. Quality control (QC) and assurance (QA)

　 1) Auditing

　 2) Verification of medical legitimacy (medical check)

E. Support for Site Management Organization (SMO)

　 1) Establishment of trial system in medical institution

　 2) Management of clinical research coordinators (CRCs)

　 3) Application for the IRB review 

F. Medical Education

　 1) Education and training for clinical research associates (CRA) /coordinators (CRC)

　 2) Education and training for medical representatives (MR)

　 3) Lecture for　GCP, GPSP, GMP et ａl.

[ II ] Production, Exhibition and Sale of Waki-Ceramic-Flowers

We will produce, exhibit and sale “Waki--Ceramic=Flower” products which are one of creative arts demonstrating natural wonderful beauty of various lovely flowers on earth and can be remained unchanged and well preserved in their individual shapes and beautiful colors of every flowers for a long time or forever.
Her hand-made products of “Waki-Ceramic-Flower” has been created by Mrs. Hiroko Tabei, who has truly loved natural lovely flowers in her life and enjoyed various seasonable changes of such wonderful beauty on earth and also long　experienced　in ceramic art. After kneading the bone-chine　or ceramic clay thoroughly, every flowers, thin petals, branches and leaves must be carefully hand-made piece by piece to express their individual shapes and various frills of every flowers and thin petals, which are firing and heating at high temperature several times in the electric kiln to get various beautiful colors, then put them together.  
It is extremely valuable that Waki-Ceramic-Flower can be arranged in any vase or pot on display as you like and also be remained unchanged and preserved well in such individual shapes and beautiful colors for a long time. You can enjoy these final hand-made products of Waki-Ceramic-Flower, demonstrating such wonderful beauty and colors of　natural lovely flowers on earth. You may also exhibit them as your best decoration at any rooms of your house.   

  Profile and Activities of Hiroko Tabei (Progenitor)

Hiroko Tabei (Ceramic Artist）has created her own Waki-Ceramic-Flower by the world 's first Technology  for making her ceramic flowers. Although most original ceramic products areusually plates, vases/pots, dolls or animals etc. ,she was creating her style and brand-newceramic art for ceramic flowers.  Nobody had gotten her vision, originality and natural challenge. She married with Dr. Toru Tabei, M.D, ( graduated from Sch. Med. Univ. of Chiba and Ph.D. of Sch. Med. Univ. of Tokyo).

Ref. URL： https://www.waki-ceramic-flower.com/