Site Management Organization in Japan (SMO)
Shin Nippon Biomedical Laboratories Group offers Site Management Organization (SMO) services for clinical trials. Our SMO offers support for clinical trials on a wide variety of applications conducted at medical institutions across Japan. Since the daily routine of medical institutions can be time consuming and complex, and doctors and nurses are engaged in patient treatment, it can be difficult to prepare to allocate this valuable time to clinical trial preparation. Unlike monitoring of clinical trial conduct by contract research organizations (CROs) in accordance with regulations as contracted by pharmaceutical manufacturers, the SMO forms an agreement with the medical institution. The SMO provides support to doctors and nurses for the administrative procedures involved in clinical trials and by conducting information seminars. The SNBL Group offers both clinical CRO services (PPD-SNBL, KK) and SMO services (SNBL Clinical Pharmacology Center, Ltd.), but independent systems are established to ensure that no information is shared between the two entities. Rigorous security ensures that the CRO and SMO businesses are completely separate by employing measures such as fingerprint authentication required at the entrance to the SMO headquarters in Osaka.
Our SMO provides the following support:
1. Clinical Research Coordinator (CRC): supports physicians and patients participating in clinical trials, physician-led clinical trials, and clinical research
2. Preparation for clinical trials: from managing standard operating procedures (SOPs) and GCP documentation to the training of medical personnel about investigational new drugs
3. Support for business operations: establishing clinical trial sites and training staff of medical institutions
4. Support for Institutional Review Board (IRB): SOP preparation, training of inspectors and committee members of the IRB, preparation and management of periodic meetings
5. Dispatch and Training of Clinical Research Coordinators
ALMEC Co., Ltd. has become Shin Nippon Biomedical Laboratories SMO, Ltd.
Almec offers Site Management Organization services in Japan. For more information, visit this website.
PPD-SNBL K.K. supports every step in a clinical trial, from the creation and design of specific protocols, selection of trial sites and investigators, monitoring of testing and data aggregation, statistical analysis, comprehensive reporting, to the creation of the document new drug applications. Additionally, the clinical pharmacology research department offers pharmacokinetics and pharmacodynamics studies and we have established pharmacology disease models. Due to our extensive experience, we work extremely efficiently, offer accurate data, and always strive to establish close communication with clients through all stages of a drug trial.
To this end, we enhance human resource development education in the clinical business sector.
We are working to enhance education and training, and accordingly, have prioritized the following goals:
Introductory education and training:
Monitoring candidates: Training of monitors to meet monitoring requirements
Prospective clinical test sites: Mastery of basic matters necessary for business operations
Continuing education and training:
Nominated monitors: Maintenance and improvement of monitoring requirements
Clinical test sites: Maintenance and improvement of job performance
Please click here for detailed information about clinical trials offered by PPD.