CLINICAL RESEARCH MANAGEMENT SERVICES

Clinical Research | Clinical Research Associates | Project Management | Data Management | Medical Writing | Regulatory Affairs | Contact Information
DATA MANAGEMENT

BCF will handle all your data management needs through an affiliated company.

There is close integration of data management, statistical, and medical expertise on every project. The timelines and scope of work are clearly defined before the project starts.

The work follows the format of the clients’ choice with straightforward and frequent communication between the client and BCF. Following are the services we provide.

OUR SERVICES

• Data Management
  • Database Design
  • Case Report Form (CRF) annotation
  • Double key data entry and validation
  • Coding (thesauruses of client’s choice) for Adverse Events, Medical History and concomitant medications
  • Edit checks and data validation
  • Data Clarification Form (DCF- data query) generation
  • Data Entry and Data Management Flowchart
• Statistical Services
  • Study Design
  • Statistical analysis plans
  • Statistical analysis
    • Efficacy
    • Safety
    • Exploratory
    • IES
    • ISS
    • Specialized Clinical Pharmacological Analysis (i.e. bioequivalence, and PK/PD modeling, Preclinical, Manufacturing Analysis)
  • Statistical Reports
• Clinical Research Services
  • Development Plan Design and Preparation
  • Protocol Design and Preparation
  • Case Report Form Design
  • Preparation of Integrated Clinical and Statistical Reports and Other Clinical Documents
  • Clinical Manuscript Preparation
  • PowerPoint Presentation Preparation

INFORMATION TECHNOLOGY SERVICES

• Dedicated Data Management and Statistics Client Server System
  • EtherNet Network Server and Clients
  • SAS 6.12 & 8.2 Software for Data Management and Statistics
• Stand-alone network, not connected to the Internet
• Login and passwords required for all users
• Current Versions of Virus Detection Software
• Full weekly and Daily increment backups
• Off-site storage of back-ups

CRF DESIGN

• Design in either Pagemaker or Word
• CRF completion guidelines
• Print CRFs on NCR paper

DCF TRACKING SYSTEM

• Generate and Review all DCFs against CRFs to identify “Go” and “Don’t Go” DCFs
• All “Go” DCFs will be tracked in the DCF output system
• All resolved DCFs will be tracked in the same system
• DCF status can be reported through this tracking system

CRF TRACKING SYSTEM

• Designed in SAS FE Edit
  • CRF Tracking Log
• Provided to clients
• User-friendly

CRF ANNOTATION

• Use Adobe Acrobat to Annotate CRFs
• Annotation is completed in different colors
  • User-friendly to CRAs, SAS programmers and statisticians

DATA ENTRY

• GCP: Double Data Entry
• SAS FSP Custom-made Entry Screens
• Electronic Audit Trail for all entries and all changes

MEDICAL CODING

• Medical History
  • ICD-9-CM, MedDRA
• Adverse Events
  • MedDRA, COSTART, WHO-ART
• Concomitant Medications
  • WHO-Drug, BNF

SAS PROGRAM VALIDATION

• A SAS programmer fully documents the SAS program
• A second SAS programmer generates benchmark results with an independent program
• The results from these two independent SAS programs are compared
• All validation documents are archived

EDIT CHECK SAS PROGRAM VALIDATION

• Create dummy data for five patients
• Insure all flags will be triggered
• Output includes all related data and the query language