Our focus is implementing clinical trials in physician's practices. We handle everything from study startup to closeout with no costs to the physician. We provide any research-specific equipment and manage every detail of the clinical trial process. Our goal is to empower physicians to offer better care to their patients with no risk and little burden.
We provide the following services as part of site management:
Subject study visits
Study/site point of contact
Monitoring visits and correspondence
Electronic Data Capture entry
Marketing and advertising
SOP development and implementation
Execution of Confidentiality Disclosure Agreements
Site selection process
Contract and budget negotiation
Regulatory and startup document completion
IRB submission and correspondence
Source document generation
We offer a variety of consulting services for existing sites who might need assistance with specific tasks. We will work with you to find a timeline and budget that fits your needs. We offer the following services:
SOP Development and Implementation
We will work closely with your site to develop written procedures with detailed instructions to record routine operations, processes, and practices to assure that research tasks are carried out in accordance with institutional, state and federal guidelines.
Source Document Preparation
Each protocol provides its own challenges. We will analyze study material to generate accurate and clear source documents that ensure your site is following good documentation practices and collecting relevant data in accordance with the protocol.
Study Identification and Selection
We can leverage our various industry connections to find trials that are appropriate your interests and capabilities. Let us help you locate studies, complete feasibility questionnaires, and manage the site selection process.
We can provide CTMS access in order to utilize electronic source, track patient visits, reconcile study payments, invoice relevant study items and ensure complete operational and financial management for your trials.
We have experience working with a variety of sponsors and both local and central IRBs. We will coordinate with both sponsor and IRB to make certain that regulatory and IRB submissions are handled in a timely and accurate manner.
Need assistance with any additional aspect of clinical research? Contact us to find out how we can use our decades of site-level experience to help you.
We've worked with the following sponsors and CROs:
We have also worked with the following IRBs and vendors: