BioCAB - Services

Data Management

• CRF receipt and tracking
• Double data entry
• Data Management Plan development
• CRF design and development
• Discrepancy management and DCF generation and resolution
• SAE and external data reconciliation
• Database lock and delivery
• Deliverables management

Database Development & Programming

• Database development
• Edit check programming and validation
• Randomization and drug derivation (external or internal)
• SAS dataset development and validation
• External data importing
• Data mapping and export

Clinical Coding

• Dictionary setup and maintenance (MedDRA™ and WHO-DD™)
• Clinical coding of ‘no-hit’ terms
• Clinical coding query processing
• Coding review reporting

Auditing and QC

• CRF to database auditing and reporting

Remote Data Capture (RDC) Investigator Site Set Up and Training

• Design RDC system security and infrastructure requirements at
  the site
• Provide hardware setup and training
• Establish site based discrepancy management specifications
• Provide site based data entry and discrepancy resolution training
• Setup technical support (help desk)
   

Statistical Analysis and Programming*

• Provide interface management with statistician
• Statistical Analysis Plan Development
• Table/listings/figures programming and validation
• Statistical Report

* BioCAB Statistical Analysis and Programming services provided for BioCAB by Everest Clinical Research Services, Inc.

Study Management**

• General Project Management
• Rapid Start-Up
• Management of Investigator Contracting and Payments
• Patient Recruitment/Strategy Development
• Study Site Management
• Study Site Monitoring

** BioCAB Study Management services provided for BioCAB by CE³, Inc.

Our Partner:

CE³, Inc.
http://www.ce3inc.com
CE³, Inc. is a contract research organization headquartered in Branford, CT specializing in the management of Phase I-IV clinical trials.  Please visit their corporate website for more information on CE3 leadership and services.