Our Services

Assist with development of the following study documents:

>Clinical Investigational Protocol

>Informed Consent Form

>CRFs/Source worksheets

>Instructions for Use

>Investigator Brochure

>Project management oversight

>Protocol review/feedback

>Investigational site identification/selection

>Contracts & budget development

>Trial Master File & Investigational Site Files

>Central IRB/EC submission(s)

>Local IRB/EC submission(s)

>Patient recruitment services

>CEC, DSMB, steering committee management

>Project training

>Vendor management

>Investigator meeting(s)

>Investigational Product management/accountability

>Clinical study supply management and oversight

>Interim data quality review(s)

>Site payments/invoice tracking

>Monitoring Plan

>Feasibility/site identification

>Site selection/qualification

>Site activation oversite

>Clinical study monitoring

>Site training

>SAE/UADE reporting

>SAE document collection/tracking

>Site audits

Additional service offerings farmed out to our network of Partners:

>Regulatory/Quality

>Medical Writing

>Data Management

>Biostatistics