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.
Drug allocation services
At blind trials, we provide service of creating randomization lists and emergency codes, as well as allocating investigational drugs, and ensure that the blind status is maintained unless a code is broken.
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.
CDISC standardization support services
We provide support for consultation on CDISC models, creation of clinical database, conversion of data, etc. based on CDISC SDTM.
Statistical analysis standardization and SOP revision service
With standardization of statistical analytical services, we support cost-savings and operational efficiency.
Consulting and outsourcing service of global regulatory submission
We support global regulatory submission in liaison with overseas consultants and vendors of wide experience.
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.
Regulatory operations support (eCTD、Gateway)
Based on the experience in supporting creation of archiving copies of eCTD, we offer complete off-site outsourcing service for the first time in the industry.
Electronic assessment and consulting services
Full support for process maintenance required to handle the next generation of electronic submissions from CDISC formatted data creation to eCTD compilation and gateway submission.
CSV support service for system implementation
Support for validation in implementing systems such as for clinical development, pharmaceutical application, postmarketing surveillance, and pharmacovigilance.
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.
BESTS – Bioequivalence test system
BESTS is the software application which conforms to guidelines for bioequivalence test of generic drugs.
SWIFTeS – Tool for support of NDA document creation
By using Microsoft Word templates that assist creation of eCTD documents, users can create application documents more smoothly in compliance with eCTD specification.
SWIFTeS Proof – Microsoft Word Text Proofreading Tool
SWIFTeS Proof is a simple, cost-effective tool to solve a problem with ensuring a level of word and sentence consistency throughout your documents.
ToolBox – PDF processing tool
PDF processing tool provided by Computer Sciences Corporation(CSC) with a proven track record in the US and Europe. By simply adding plug-ins to Acrobat, users can access functions used at pharmaceutical companies around the world.
Publisher – Publishing system
A publishing system provided by CSC with a proven track record in the US and Europe.
eCTDXPress – eCTD compilation system
eCTD compilation system provided by CSC with a proven track record in the US and Europe. In Japan too, eCDXPress holds a top class share in the eCTD tool category.
OpenFlow – PDF rendition/publishing system
PDF rendition/report publishing provides easy operation. Users can create high quality PDF files automatically, which can be submitted as leaf files of eCTD (submission ready).
i-Clinical – cloud solution to comprehensively support pharmaceutical development
i-Clinical, massive virtual space on the cloud, empowers more efficient collaboration among anyone involved in pharmaceuticals regardless of place and time. i-Clinical can be utilized as infrastructure to closely “connect” various information and know-how for more flexible and innovative proceeding of pharmaceutical operations from clinical development through post-marketing.
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.
Support for clinical trial notifications
We handle various procedures, from data entry related to clinical trial notifications, to CD-R creation and bookbinding for delivery. We also check notification deadlines of each trial and consistencies with other trials.
zenflow Alloc – Allocation/patient enrollment system
An allocation/patient enrollment system developed by CAC Croit based on our extensive experience in contracted business and IT services. Systems can be quickly enabled as standard features necessary for patient enrollment have already been included.
zenflow Alloc-Light for independent clinical study/PMS
A reasonable allocation/patient enrollment system that can be implemented in about two weeks.