Solutions-Acrostar SMO

SSU process flowchart

Doc. Preparation

Doc. Signature / Stamp

Submission to GCP office

GCP Approval

EC Submission

EC Meeting

Kick-off Meeting

Contract Negotiation & Signature

OHGRA Support

Approval Release

Re-Submission

Follow Comments

Services

Start-up

Site’s project feasibility study

Big data survey Institute information research Investigator information research Source quantity and enrollment progress assessment Site assessment report

Ethics submissions for project initiation and support for genetic office application

Assisting site in project initiation, collection of ethical information and data preparation and revision Project initiation and ethical information pre-review Support for project initiation meeting, clinical study management committee and ethics committee Assisting genetic office in registration and other procedures

Contract negotiation & site initiation support

Collection of cost details and contract preparation, negotiation and signing Receipt and management of trial supplies and drugs Collection and filing of site qualification documentation Initiation meeting support

Enrollment & Follow-Up Phase

Subject screening and recruitment

Accurately screen subjects according to protocol requirements

Huge investigator repository to efficiently expedite enrollment, especially in oncology research

Collaborate with relevant organizations and enterprises to provide multi-channel recruitment approaches, especially for rare diseases and chronic diseases

Subject management

Track the whole process of patients’ treatment and follow-up according to ICH-GCP guidelines and clinical trial protocol requirements to effectively control the dropout rate

Trial data entry & review

Help investigators sort and complete the original records in an efficient and quality manner

Enter data and answer questions efficiently according to the trial and customer’s requirements to ensure the timely data entry

Site management & maintenance

Institute and EC daily communication and maintenance

Study documentation management

Investigational drug and supplies management

Financial management of project

Support for monitoring，audit and inspection

Reporting of AEs/SAEs

AE/SAE progression tracking

Retention and filing of safety event documentation

Assist in AE/SAE information collection, recording and reporting

Closed 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