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