Capabilities

Clinical Data Management (CDM) Consulting Services

 General Clinical Data Management Tasks

  • Study Startup Activities
  • Case Report Form (CRF) Design and Annotation
  • Creation of Data Management Documentation
  • Data Review and Query Generation/Resolution
  • Adverse Event and Medication Coding (MedDRA, WHO-DD)
  • Serious Adverse Event (SAE) Reconciliation
  • Database Lock Activities
  • Database Audits

SAS Programming and Validation

  • Data Migration
  • Tables, Listings, and Graphs
  • Data Validation Checks/Edit Checks

Process Development and Documentation 

  • CDM Process Improvement
  • CDM Standard Operating Procedures (SOPs)
  • CDM Work Instructions
  • Creation of System User Manuals
  • Creation of Data Dictionaries and Other Database Documentation
  • General Technical and Report Writing

Training Services

  • Good Clinical Practices (GCP), Clinical Trials, and CDM Skills Training
  • Training in Various CDM Systems and Software
  • Training in Electronic Data Capture (EDC) Systems and Methodology
  • Mentoring and Development of New CDM Staff

Vendor Management for Outsourced Studies

  • Assistance with Vendor Selection and Qualification (CRO, Laboratory, EDC)
  • Assistance with Determining Optimal Outsourcing Strategies
  • Conducting Vendor Audits (Pre-Contract and For Cause Audits)
  • Review and Quality Control of Vendor Deliverables

CDM Technical Projects

  • Planning & Execution of User Acceptance Testing (UAT) Projects
  • Data Mapping and Legacy Data Migration
  • Preparation of Regulatory Submission Datasets
  • System Validation (Creation of Test Scripts, Supervision of Execution)
  • Writing and Review of Programming Specifications
  • Generation or Review of Test Data for UAT/Validation Projects
  • Electronic Data Transfers (Vendor Negotiation, Specifications, Testing, and Approval)

Development of Data Standards and Libraries

  • Creation of Case Report Form (CRF) Standard Libraries
  • Design and Programming of Validation Check Libraries
  • Creation of Standard Document Templates

CDM System Selection and Implementation

  • Electronic Data Capture (EDC) Systems
  • Clinical Data Management Systems