Site Management Organization

Site Management Organization

Study Management

We provide infrastructure and research setup to run your clinical studies from start to completion. We stand and collaborate with you through study feasibility, budgeting, staffing, regulatory approvals, recruitment, audits and closeout.  

Study Contract, Budget And Expense Management

Develop budget for adequate funding and set up billing plan for proper cost allocations, to ensure all study related expenses are covered. Contractual negotiations for terms and conditions. Funds flow management.

Subject Recruitment And Retention

Providing subject recruitment and retention services to new and established research practices and investigators.

Subject Safety Management

Monitoring patient safety is a high priority and critical component throughout the trial phase. Our trained researchers proactively ensure a systematic approach to safety monitoring and educating study staff about safety oversight.

Ensuring Study Compliance

A clinical trial requires following directions in accordance to the protocol, IRB policies, applicable regulations and standard guidelines. Study compliance results in clean, complete, and accurate data.

IRB Management

Working closely with the IRB in approving protocols, new amendments, continuing reviews, reporting Ups, AEs, SAEs, deviations and violations as required.

GCP Documents And Training

ICH-GCP guidelines are the ethical and scientific quality standard for designing, conducting, and reporting clinical trials. The ICH’s unified standard is to provide training to all research personnel.

Quality Assurance

The QA that we have in place for IRB submissions and data monitoring consists of multiple reviews and corrections, followed by a final submission and reporting.

Logistics Management

A smoothly ran clinical site is achieved by planning, control, and implementation. Keeping an organized patient schedule, completing protocol visit assessments, and working closely with site investigators and sponsors are all crucial factors in logistic management.