Should the need arise, Cobridge can arrange for bridging studies and other clinical development activities for product registration in Japan, including the mandatory pretrial consultation with PMDA. We also coordinate pharmaceutical and pharmaco-toxicological testing by contract laboratories on behalf of overseas clients.

The following is a description of the services Cobridge provides, either on an individual or integrated basis, depending on client needs:

Preparation of GCP SOPs

In consideration of the client's business conditions, we provide services for preparation and revision of a local office's GCP SOPs to meet the standards of current Japanese GCPs.

Study Design

We serve our clients in the critical area of study design by applying our experience in the preparation of study protocols and case report forms, and investigator's brochures. We can also conduct the mandatory pretrial consultations with Japanese regulatory authorities.

Investigator Recruitment

We solicit the participation of investigators, who contract either with Cobridge — acting in capacity as a client's service — or directly with our clients.

Calculation of sample size

We also provide services for calculation of sample size which is an important factor for local clinical trial planning.

Study Implementation

Clinical trials are managed by a project director who supervises implementation through specialized CROs.

Quality Control

We undertake quality control services for CRFs and documentation related to GCPs for clinical trials conducted not only in Japan, but also overseas.
The following services are available: data comparison of CRFs with electronic files, preparation of check lists for documents related to GCPs, manual data checking, logical checks and scientific review.

Data Management and Biostatistical Analysis

Our biostatistical analysis services are managed by professionals with industry experience in local and multinational clinical trials. We provide the integrated services from preparation of data-input forms to final statistical analysis.

Medical Writing and Regulatory Services

We provide medical report writing and regulatory services to our clients, including study reports, manuscripts, risk/benefit assessment reports and package inserts.