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

---