· Proactive and efficient management of study progress and budget
· Provide transparent communication with overseas customers
· Establish a professional relationship with our stakeholders
Monitoring is our KEY. · ACCERISE’s motivated and experienced monitors gain a high reputation
from local and global pharmaceutical companies
· Average 5.5 years monitor experiences
· More than half of monitors experience oncology studies
· Satisfying experiences across many different therapeutic areas
· Low turnover rate secures stable study management and progress
We provide broad consultations and solutions; regulatory strategy planning, MDA consulting, draft application materials, various licenses.
· Strategy for drug development, planning, and clinical studies
· Support and implementation of PMDA consulting meeting and
· Support and draft the secure CTN
· Consulting for the application package and CTD
· Broad knowledge including the application including the orphan and
· Interview with the clinical experts and KOLs
Our experiences and know-how provides our client with the effectual list of highly-motivated investigators and willing sites to achieve early enrollment and registration of subjects.
Draft all of the relevant source documents.
· CIB, Protocol, ICF, CSR
CIOMS, Publication, Non-clinical study reports, Validation test reports
Translation service for overseas customers
We control all source documents and provides the quality control.
We lead the handling of PMDA consultation and inquiries.
One-stop DM/STAT service from launch to operation
· Advanced skills of the establishment/operation several DM system
· Create SAP, figure layout, analysis program, figure output, SAR
In Country Representative service and consultation, database entry,
translation, drafting the relevant forms and reports · Handle the individual case safety reports
· Check/assess/handle the case reports
· Report to authorities
· Safety evaluation committee
In Country Representative service
· IP/study supply management, importation, courier control, collection
· IP management according to the relevant regulation and client's
· Vendor selection, management