Clinical Trial Management Services

Mission Statement:

Help investigators successfully manage GCP compliant Clinical Trials
in a way that is most beneficial to their sites and subjects.

Services we provide:

Service

Description

Investigator Site File Management

Certified electronic regulatory record management
without the hassle of giant regulatory file binders
taking up space in your office.

Source Document Creation

Subject source document tailored to your
specific site and protocol.

Budget/CTA negotiation assistance

Not all sites are compensated equally!!
We offer several years experience with both big and small pharmaceutical companies.
Let us help you figure out what fair market value
really means for you based on your site location,
overhead and ability to successfully run a trial.

Certified Copy Assistance and Scanning

We're here to help you with FDA approved document management methods
to ensure audit readiness.

Website Design and Management

Keep your site current with our media management expertise
to help boost your enrollment numbers
and provide you with more streamline public contact

Site specific SOP Writing and Training

Assistance for staff

Study start-up

Submission packages

What we have to offer:

Compliance with all Clinical Investigator Responsibilities per FDA guidelines (21 CFR 312.60 - 312.69)
FDA GCP Certified - Clinical Trial Site Management since 2004