Life Cycle Management
We offer total support with one-stop services. With a combination of writing and regulatory operation support services, we can make efficient and optimal proposals for submission to the authorities.
Clinical trial monitoring services
With experienced staff in drug development, we provide total support for operations such as clinical trial monitoring, quality control, data management, statistical analysis etc.
Patient registration services
Based on a protocol, we provide support for speedy eligibility assessment. We ensure quality with double-check by two separate persons.
Taking advantage of extensive experience in building and operating Electronic Data Capture (EDC) systems, we provide one-stop services from the initialization of data management (DM) tasks through to operations.
Statistical analysis services
We provide a series of statistical analysis services such as statistical analysis plan development, layout design of table, figures and listings, statistical analysis programming, output of table, figures and listings, statistical analysis report development etc.
Statistical analysis standardization and SOP revision service
With standardization of statistical analytical services, we support cost-savings and operational efficiency.
CSV consulting services
We can propose a plan optimized to meet your system size or risk concerns based on our extensive experience. You can choose from a wide range of system lifecycle services from system implementation and preparation through to the operational phase and disposal.
CSV support service for system implementation
Support for validation in implementing systems such as for clinical development, pharmaceutical application, postmarketing surveillance, and pharmacovigilance.
Pharmacovigilance support service
We offer outsourcing service through best suited procedures, depending on the requirements of your company.
We provide IT support tools including useful risk trend analysis to the safety control managers who must make a timely and appropriate decision for patient benefit.
We provide medical science services for real world data study in all processes involved in developing and conducting a protocol (framing a hypothesis, designing study, analysis, and writing papers) as follows.
Contracting and progress management services
From contracting with institutions to management of case report collection status, we provide total support for procedures that arise in PMS and progress management services.
PMS standardization and SOP revision support service
With standardization of statistical analytical services, we support cost-savings and operational efficiency improvement.
Important Risk Visualizer® for RMP
Benefits from offering a safety or medical affairs department a list of critical risk information in all required safety specification allow customers to have panoramic grasp of safety countermeasure situation and effective support of activities based on Risk Management Plan (RMP).
Spontaneous Reporting Database
EDC system implementation and operation services
We select an appropriate system, which meet your needs, and provide implementation support with our experienced consultants. We also offer a variety of related services to help you run a smooth EDC operation.
zenflow Surveillance – Contract progress management system
Manage contracts and progress for PMS. Can be implemented in as little as a month.
zenflow Alloc-Light for independent clinical study/PMS
A reasonable allocation/patient enrollment system that can be implemented in about two weeks.