Comprehensive Clinical Trial Administrative Service Based on Advanced Expertise
Establishment and operation of clinical trial infrastructure at clinical sites accommodating diverse needs
EP-SOGO supports you comprehensively to create an environment required for clinical trials with our qualified site management associates (SMAs). This includes, but not limited to coordination of establishing clinical trial centers and IRBs (Institutional Review Board), preparation of the documents stipulated in GCP and training for the site staff on the general concept and details of GCP. EP-SOGO has a wide range of achievements for supporting any size of clinical sites. Depending on a variety of needs, EP-SOGO supports you totally or for a single task.
Strength of Clinical Trial Administrative Service of EP-SOGO
EP-SOGO not only creates or stores documents required for clinical trials but also provides optimal support depending on whether the site has in-house IRB or uses central IRB. Further, to make clinical trial operations more efficient and leverage the limited resources more effectively at clinical sites, EP-SOGO can offer you various proposals. Also, according to your request, EP-SOGO provides you with different options such as digitization or paperless documentations. These options are popular with our customers because it leads to reducing IRB members’ burden, creating more space in buildings of clinical sites, saving resources and protecting environment.
EP-SOGO’s human resource development targeting higher level of expertise to meet the future market
To improve skills as SMAs, EP-SOGO constantly holds study meetings of legal regulations and case reviews on a regular basis to study the latest information on clinical trials. EP-SOGO keeps itself updated about the regulations through participation in seminars or conferences of various external organizations to share with the whole company in a timely manner, while paying attention to trends of clinical trials, medicine and national policies, etc. Also, to proactively adapt to environmental changes in clinical studies and trials, case study reviews are led by front line staff daily basis to standardize operations. This will help all staff achieve the highest quality of the up-to-date services. In addition to these local trainings, EP-SOGO regularly holds group trainings specifically designed for the assigned duties, inviting SMAs from various regions.
- Sharing the latest knowledge and know-how to further improve our operations.
- Raising the awareness and improving the skills of SMAs as specialists of Site Management Associates operations.
- Checking systems to improve quality
- Establishment or improvement of process to prevent errors
- Encouraging SMAs to acquire SMA Qualifications officially certified by Japan SMO Association.