Service

AC Medical strongly advance on contribute to improving healthcare.

Trustworthy
business partner
  • Advanced

    (Move forward)

  • &
  • Creative

    (Creation of new value)

For our Clients, For our Employees and All For Patients

Featured our services

1

Mainly CRO, CSO and MA, these three divisions provide high-quality services with each great expertise.

2

Offering the most appropriate process of combining human resource and IT services.

3

A wide range of net work, a business tie-up with the company that has been used successfully overseas.

CRO

Monitoring

Quick and appropriate information gathering and provision

At AC Medical, based on consultation with customers, and founded on detailed communication with all concerned—such as negotiation with principal investigators and medical institutions—we support total operational management for smooth monitoring(*).In addition, we provide rapid reporting of monitoring through suitable management of the clinical trial process and strict quality control.
*Monitoring = Activities pursued in order to investigate the state of progress of clinical trials, etc., guarantee that they are implemented in accordance with the GCP, clinical trial protocol and operating procedures, and ensure that they are suitably recorded and reported.

Data management and statistical analysis

Full support of case data management

From clinical development through to post marketing surveillance, we appropriately and efficiently manage the vast quantities of data required for each process. With regard to statistical analysis of data, we perform full support—from preparation of the analysis plan through to data analysis and preparation of analysis reports—and, keeping constantly abreast of the latest academic society trends and pharmaceutical needs, reach an appropriate evaluation of the new drug that is based on experience and looks from a broad statistical viewpoint.

Coding

We offer various coding related services, focusing on MedDRA and WHODrug.

Using reviews by medical experts and our own unique coding system, we perform appropriate and consistent coding, and achieve a speedy and highly accurate service.We can offer wide ranging support for not only domestic but also global trials.

 MedDRA coding

Based on the past results of coding in clinical trials, PMS and PV, and on medical judgment, we offer support for all tasks related to MedDRA coding, from preparation of coding guidelines through to coding result reviews, version upgrades, and synonym construction.Through our one-stop service, the entire coding process is implemented by personnel with more than 10 years’ experience in charge of MedDRA coding tasks.

 Drug coding

Coding specialists who have undergone UMC’s WHODrug E-learning support WHODrug coding work in accordance with your requests.Using our specially developed coding tool, the entire coding process is implemented as a one-stop service.We also offer similar services for IDF.

 WHODrug coding tool: Code Premier®

This is a special coding tool that looks from the coder’s viewpoint, and was created through joint development by system engineers and coders who understand WHODrug’s structure.We provide a coding tool that allows easy-to-use search tools and flexible usage settings.

EDC services and CDISC related services

Digitization of clinical trial data for improvement of work efficiency and compatibility with CDISC standard

 EDC services

We achieve high quality EDC services by combining IT specialists with medical and pharmaceutical specialists.In addition, we enable a total solution, from business process design through to system construction/operation and helpdesk services.

 CDISC related services

With respect to “clinical electronic data submission”, we support a series of standardizations based on the “CDISC standard”, from training through to system construction, data conversion and analysis results. We also handle legacy data conversion.

Medical writing

Urgent response support, such as preparation of application for re-examination

In addition to the SOP(*) mandated by GCP, we support the preparation of all reports, protocols and papers required, from the clinical trial preparation stage through to trial implementation and application for approval. In addition, when submitting documents, strict quality control is achieved through a multilayered review system.
*SOP (Standard Operating Procedures)

Quality assurance services

Systematic verification of operations performed from a standpoint that is independent of the audited department

As part of the quality assurance system, we perform systematic verification from a standpoint that is independent of the audited department to answer the questions: “Is the entrusted work performed in accordance with the Pharmaceutical and Medical Device Act, GCP and GPSP ordinances, protocol, and SOP?” and “Is data appropriately recorded and analyzed, and accurately reported?” We are also available for outsourcing of audit work only.

Quality control (QC) services

Implementation of QC for documents related to GCP studies, etc., and CTD documents

From clinical trials of pharmaceuticals and medical devices through to application, we perform QC for documents related to GCP studies and post marketing surveillance, and for CTD documents and reexamination application documents.

Safety information management services

Full outsourcing available

Highly experienced specialized staffs implement fully outsourced pharmacovigilance (PV) services that look from the customer’s point of view.