• Home
  • About
    • About
    • Principal Investigators
  • Services
  • Current Trials
  • Contact Us
  • Volunteers/ Participants
    • Volunteers/ Participants
    • FAQs
  • Sponsor/ CRO Information
  • Physician Information
Services


                                               ARCHIVING SERVICE                                                                         EMPLOYEE MENTORING
                                         Document Organization for                                                                     Support of Staff on an  
                                Storage to Meet Regulatory Guidelines                                                               
Ongoing Basis                                            ​          

  AUDIT SUPPORT
       Support and Assistance to  Prepare for
            Sponsor and/or FDA Audits
     Composition of Audit Finding Responses
MONITORING

Assessment of Study Documentation
for Accuracy and Completeness
Document Preparation for Sponsor Monitoring

BUDGETING
 Study Budget Creations
      Budget Tracking per Procedures for Sponsor
​Payments
      Budget Amendments
      Recruitment Budget Creation
REGULATORY FILING
 Initial Regulatory Filing for New Clinical Trials
      Annual Regulatory Filing
      Interim Regulatory Filing

        CLINICAL TRIAL MANAGEMENT
Organization, Implementation, and Over site of all Aspects of a Clinical Trial
SAFETY MONITORING
Tracking and Filing of Serious Adverse Events (SAE), Safety Reports with Study Files and
Institutional Review Boards (IRBs)

DATA ANALYSIS 
Analysis of Trial Data for Prospective or 
​Retrospective Studies
SOP CREATION 
Creation of Standard Operating Procedures and Work Instructions for Research Facility/Site. SOPS can be Individualized for the Site's Unique Criteria

​EMPLOYEE TRAINING
Basic Clinical Research Training
      Good Clinical Practice (GCP) Training
      FDA/ICH 
Guidelines Training
      Therapeutic Training
      Protocol Training

Picture
17998 Chesterfield Airport Rd., Suite 100, Chesterfield, MO 63005
©
Clinical Research Professionals (CRP) 2014