PS Site Assist
Administrative solutions for clinical research sites
PharmaSeek offers a variety of tools to help support your site during the study start-up process. Our à la carte services ranging from contract and budget negotiations to CTMS study build and consulting can be customized for the needs of your site so you can focus on patient care. PS Site Assist is a comprehensive administrative support program with many layers. These services have been developed specifically for clinical research sites to allow you to reach your site’s goals.
Site Performance Assessments
Site performance assessments identify key areas of strengths and risks within business development, marketing, physician engagement, operations, compliance, regulatory, finance, revenue cycle management, and training.
Contract and Budget Services
Outsourcing contract and budget negotiations to PharmaSeek allows sites to maximize study budgets, secure additional funds not initially offered by sponsors, and limit exposure from complex contract language.
PharmaSeek will determine if a study is considered a “qualifying clinical trial” (per the Medicare National Coverage Decision 310.1) and is eligible for reimbursement. We will then develop a study activity grid and identify appropriate coding and billing requirements.
Study Build/Data Entry in Site's CTMS
We will enter all study details as required by your site into your CTMS, and create a study calendar within your CTMS based on the protocol schedule of events and other provided documentation.
Regulatory Document Review and Completion
Regulatory documents for each study that will be drafted include: FDA 1572, financial disclosure forms, investigatory brochure receipt acknowledgement, protocol signature page, and IRB approvals.
We will assess your site’s training needs with specific project plan creation, then we will develop training programs that are specific to your site.