Flow of Central Lab Services

Project management

• Study Coordinators is in charge of

  • Preparation of Service Plan
  • Setting up data-base
  • Designing requisition and report formats
  • Designing specimen collection kit
  • Preparation of Investigator’s Manual
  • QC of lab reports
  • Transferring electronic data files

Specimen Collection Kit Preparation

• Site-specific customization capable.
• Three-colored specimen shipping bags.
• Subject ID pre-printed on the requisition form and the specimen labels.

Site Meeting

• Instruction Meeting at Clinical Sites:

  • Instruction of Kit HandlingExplain the materials kit
  • Confirmation of Specimen Pick-upDiscuss

Management of Specimen Logistics

• Logistics is one of the key success factor for Central Lab Services in Japan. MCM’s nationwide network strongly supports the logistics of samples.

Clinical Testing

• “C-Lab” and “Main Reference Lab” jointly provide a wide range of clinical testing.

• Areas of testing

  • Biochemical testing; Toxicology testing; Endocrinology testing; Tumor-associated testing; Virology testing; Immunoserology testing; Cellular immunity testing; Gene-related testing; Chromosomal testing; Hematological testing; Microbiological testing; General clinical testing; Pathological testing
  • Relevant microbiological testing and examination required in the development of antibacterial drugs.
  • Although the lab is capable of testing over 2000 test items, we are constantly looking to develop and add the very latest test items as part of our efforts to best meet clients’ needs.

Reporting & Data Services

• Customized Reporting

  Protocol-specific reporting by flexibly changing parameters, formats and transfer methods (e.g. fax, hardcopy, CD-ROM)

• Monitor support service

  Reporting of study-specific alarms and easy-to-view study progression through internet/cellular phones.

Storage and shipment of specimensSample

• Long-term storage of residual samples: Any such samples are stored correctly and securely in the laboratory’s freezing chamber.
  We can also send any samples to other institutes upon request and anonymous or anonymize the specimen.

Storage of data and documents

• All records generated in C-Lab, such as test results, audit trails, and other records for ensuring the reliability of testing data, are stored as hardcopy and electronic records as follows.

  Hardcopy records are stored in the designated archive in C-Lab for a certain retention period. After the retention period, those records are transferred to the GCP documentation archive facility. The archival period is permanent.

  Electronic records are stored on the hard disc of the system server connected to C-Lab. The retention period lasts at least 10 years. After the retention period, the records are transferred to another storage media.