Home > CRO services

CRO services

High quality, speed, cost efficiency, and globalization are the factors required for the development of pharmaceutical products.
SRL Medisearch Inc. entered into the clinical development business in April 2003. Clinical development services that we provide are clearly distinguished, making the most of our know-how accumulated by our SRL Group companies.

clinical monitoring

A Speedy and Reliable Clinical Monitoring Service

One of the key factors for the success in clinical trials is how to select the suitable investigator's site and principal investigator. In this sense, as a unique service of ours we take advantage of the abundant information, expertise, etc. that Miraca Group companies own to recommend to the customer the optimum candidate for an investigator's site and so on.
W e also attach importance to the accurate and speedy performance of monitoring services. Our CRA staffs have both the knowledge and skill necessary for clinical monitoring.
We have great regard to the nurture of personnel that will further enhance the quality of our CRA staffs.

Targets

  • Phase I,II and III clinical trial
  • Biological coordinateness testing
  • Post-production/sales clinical trial
  • Clinical study with doctor's initiative

Monitoring businesses

  • Survey and selection of investigator’s sites and of principal investigator for clinical trials in accordance with GCP
  • Explanation of the clinical trial program to the principal investigator(physician) to obtain the consent.
  • Request of clinical trial to investigator's sites and conduct of the relevant contract procedures
  • Action in response to IRB meeting results
  • Carrying out of clinical trial start-up meeting
  • Provision and withdrawal of the study drug
  • Visit and notification to investigator’s sites
  • Verification of observance of GCP and clinical protocol
  • Clinical trial progress management
  • Verification of source data
  • Formulation of monitoring reports
  • Collection and verification of CRF (Case Report Form)
  • Action to emergent safety information (critical panic alert,etc.)

Development-related businesses

In addition to the following operations, the following services are available upon request.

  • Quality control of GCP essential documents, etc.
  • Drafting of clinical protocol
  • Drafting of informed consent,etc.