Surveillance for Clinical Trials
CMIC supports a wide scope of services from monitoring (collection of site contracts, re-investigation or query, and fixed case report forms) to the post-authorization safety study (PASS). We can assist whether a study needs a plan implemented in the early phases, or our clients need continuing safety surveillance with a non-interventional study to evaluate real-world practice. Our support covers risk management development, pharmacovigilance, epidemiology studies, clinical usage analysis reporting, and more. We create and operate risk management plans (RMP), as well as support early phase post-marketing pharmacovigilance either via contract medical representatives (MR) or good pharmacovigilance (GVP) outsourcing.
Our Edge in Post-Marketing Surveillance
Extensive experience and leading track record
Our unique business model is built on expertise from working on a multi-drug, multi-Sponsor joint survey (ongoing since 1997) that covers 38 products from a total of 15 companies
Providing post-marketing surveillance monitoring and data management outsourcing services, leveraging one-stop solutions to support the entire process from drafting of Risk Management Plan (RMP) for pharmaceuticals to re-examination.
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.
- Database entry
- Patient registration plans
- Safety evaluation meeting materials
- Epidemiology studies
- Monitoring (Adverse Events, submissions to IRB, surveillance reports)
- Health economic outcomes research and technology assessment
- Project leader coordination (monitor training, records retention, self-inspection)
- Clinical usage and analysis