We have numerous experiences in a good variety of survey methods in almost all therapeutic areas.
Upon acquisition of the pharmaceutical business sector of Nihon Ultmarc Inc. by CMIC Group, CMIC PMS Co., Ltd. started on April 1st, 2013 and is specialized in providing PMS services. Nihon Ultmarc Inc. began providing PMS services since 1983, and with our experience working on projects outsourced by more than 60 clients, we have numerous experiences in a good variety of survey methods in almost all therapeutic areas.
CMIC's Edge in PMS
Extensive experience in PMS and leading track record
We support a wide scope of services from PMS monitoring (collection of site contracts, re-investigation (query) and fixation of case report form) to supporting re-examination application. Also, we have built our unique business model with experience in multi-drug, multi-Sponsor joint survey that has been ongoing since 1997, covering 38 products from a total of 15 companies.
Implementation based on track-record and experience as Marketing Authorization Holder (MAH)
With regard to the obligation of submitting Risk Management Plan (RMP) for pharmaceutical products since April 2013, we do not limit ourselves to preparation of submission materials, but leverage our know-how in clinical development, approval application and PMS as Marketing Authorization Holder (MAH) at CMIC Holdings Co., Ltd. to support implementation.
Capitalizing on its integrated capability, CMIC Group does not only provide PMS monitoring and data management outsourcing services, but also integral “one-stop shop” solution to support the entire process from drafting of Risk Management Plan (RMP) for pharmaceuticals to re-examination.
- Supporting implementation of Risk management plan (RMP)
- Early Post-marketing Phase Vigilance
- Supporting (Special) Drug Use-Results Survey / Pharmacoepidemiological Study
（Patient Registration / PMS Monitoring / Data Managemen / Statistical Analysis / Medical Writing）