Thursday, 29-Jul-2010 10:26:04 EDT
 
   
  CodeSys
PROMIS  
   
 

At the core of every PharmaSoft product and service is the
expertise of PharmaNet, a leading company focused solely
on clinical product development.

PharmaSoft provides a single platform containing a complete
suite of solutions, including an easy-to-use system for clinical
data management and electronic data capture.

  PharmaSoft: Information Technology for the Real World of Clinical Development
  WebSys: Clinical Data Management System (CDMS)
  An easy-to-use CDMS for collecting and managing patient data.
 
 
 
 
 
 
 
Double-data entry
EDC
Hybrid data capture
Query management
Review tracking
Status reporting
 
  PROMIS: Project Management Information System
  Entry management and reporting of administrative and regulatory project information.
 
 
 
 
 
 
 
Regulatory approvals (IEC, IRB, country)
Monitor visits
Site information
Patient milestones
Regulatory documents
Protocol violations and deviations
 
  FaxSys: Facsimile Data Capture System
  Collects data from faxed or scanned CRFs for entry into a common database.
 
 
 
 
 
 
 
 
Manual and automated verification modes
Single interface for review/query
Faxed CRF is similar to standard paper CRF
No special site equipment needed
Secure data access via WebSys
Supports ICR/OCR/OMR
Minimal training and user-support required
 
  TeleSys: Interactive Voice Response System
  Provides patient randomization and drug management services, and automates critical
aspects of clinical trial management, including site activation, enrollment, emergency
code break, and discontinuation.
 
 
 
 
 
 
Web-based and fax-back reporting
Tone and pulse compliant
Complex randomization capability
Diary data and reminders
Multi-language capability
 
  SafetySys: Serious Adverse Event System
  Handles clinical serious adverse events, including tracking and reporting.
 
 
 
 
 
 
 
 
Integral adverse-event coding
Point-and-click navigation
Concurrent access by multiple team members
Rigorous security, including encrypted safety data and user verification
Supports drugs, biologics, and devices
Cumulative summary reporting
CIOMS and MedWatch formats
 
  CodeSys: Thesaurus Management System
  Manages a broad range of coding dictionaries, and supports synonyms, dictionary customization,
and convenient lookups. Operates seamlessly with PharmaSoft products and may be used with
data management systems that support an open database.
 
 
 
 
 
 
Works with most CDM systems
Sophisticated autocoding
Manual coding
Dictionary browsing
MedDRA, WHO-ART, WHO-DRUG, COSTART, ICD-9, and more
 
  LabSys: Laboratory Data Management System
  Stores, processes, and analyzes laboratory data. Standard edit checks programmed into LabSys automatically generate electronic queries that are dispatched to WebSys-equipped sites, or paper queries dispatched to sites that use paper or faxed CRFs.
 
 
 
 
 
 
 
Multiple mapping options
Demographic reconciliation
Automated flags/queries
Data importation
Manages laboratory normal ranges
Supports both central and local labs