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Consult Experts

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+886 2 2809 3000

Address：Taipei:10F, No.47, Minquan Rd., Tamsui District, New Taipei City 25173, Taiwan

+886 2 2809 3000

contact.acrostar@acrostarsmo.com

Solutions

Acrostar SMO is continuously improving the quality and peer recognition of clinical trials

Service scope

SC Service

Subject recruitment, schedule management, source document management, case report form management, lab sampling/handling/shipping, AE/SAE reporting, night-shift support (if applicable), subject visit schedule management

Site Management

Data entry, administrative support, staff training arrangement, audit/inspection support, equipment management, visit schedule, signature arrangement

Reporting

IRB initial/amendment submission assistance, close-out report, AE/SAE reporting, protocol deviation reporting

Contact Center

Real-time call response, subject general query handling, 24-hour customer call center (planned), scheduling management, privacy protection consultation

Miscellaneous

Any other miscellaneous task

Service flow

Contracting

MSA
Bipartite
Tripartite

Preparation

SMA Assignment
SMA Training (Site training Protocol training)
System set-up

PI Meeting

Conducted by SMO mgt
Workstation system access RnR
Train PI/SC on SMO service scope

Site Support

SC service
Data mgt
Visit report
On-going training & quality management

Periodic Reporting

As agreed with sponsor
Format TBD

Close-out

Site close out
Project close out

Close Out

Assist with query resolution

Communicate with investigators to resolve queries in an efficient and quality manner Two-way communication and feedback to ensure the quality of query resolution

Site closure

Institute QC support Audit/inspection support and rectification Ethics closure and review meeting Submission of sub-site summary reports Financial settlement Documentation filing

On-site audit support