Clinical Development

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 Enrollment/Allocation

Based on a protocol, we provide support for speedy eligibility assessment. We ensure quality with double-check by two separate persons.

Investigational Product Packaging and Labeling

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.

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.

Data Management

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.

EDC/ePRO System Implementation

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.

Statistical analysis

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.

Medical writing

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.

CDISC standardization support services

We provide support for consultation on CDISC models, creation of clinical database, conversion of data, etc. based on CDISC SDTM.

eCTD Compilation and Submissions via 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.

BESTS – Bioequivalence test system

BESTS is the software application which conforms to guidelines for bioequivalence test of generic drugs.

zenflow Alloc – Allocation/patient enrollment system

An allocation/patient enrollment system developed by EP 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.

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 DXC.tecnology 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 DXC.tecnology with a proven track record in the US and Europe.

eCTDXPress – eCTD compilation system

eCTD compilation system provided by DXC.tecnology with a proven track record in the US and Europe. In Japan too, eCDXPress holds a top class share in the eCTD tool category.

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.

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.

CSV support service for system implementation

Support for validation in implementing systems such as for clinical development, pharmaceutical application, postmarketing surveillance, and pharmacovigilance.

Medical Science Services for Real World Data Study

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.