Il gruppo di gestione dati INNOPHARMA ha le risorse e l’esperienza per gestire la mole di dati generata dai trial clinici.

Sappiamo che il corretto trattamento dei dati clinici è essenziale per il successo di un trial. La gestione dati INNOPHARMA è in grado di offrire un ampio ventaglio di servizi per garantire l’accurata raccolta, organizzazione, validazione e analisi dei dati stessi.

SERVIZI DI GESTIONE DATI

  • Data Management Plan
  • CRF Design
  • Administration and development of platforms for e-CRF using laptop computers or in a centralized environment using the Internet
  • Database design and setup
  • Database validation and auditing
  • Double Data Entry and verification
  • Remote Data Capture
  • Planning, creation and validation of computerized edit checks
  • Data Validation and Query management
  • Data Correction
  • Incorporation and cleaning of other electronic data (lab, ECG, etc.)
  • Data Medical Coding
  • Adverse Event/Medication Coding
  • Serious Adverse Event Reconciliation
  • Management of e-CRF stamp
  • Database Closure
  • Data Management Report
  • CRF tracking and computer-generated Audit Trail
  • Creation of study-specific manuals for e-CRF training
  • Metrics
  • IVRs
  • Real Time communication of Adverse Event by email and sms

Data Management and e-CRF creation tool

SAS-PheedIt is a SAS solution, which is a standard in the Life Science industry for data management, analysis and clinical trial reporting.
SAS-PheedIt is a complete web-based application built on SAS and web technology for remote data capture and double data entry and manages all the steps in the process of bringing data from investigator sites to a clinical study database prepared for analysis.
Thanks to the solution’s web technology, data entry can be done by anyone who has access to the system and the web.
SAS-PheedIt is a very powerful web-based tool that is flexible, dynamic, user-friendly and very easy to access from anywhere.

Regulatory compliance:

  • Enables FDA 21 CFR part 11 compliance
  • Administration of Users, Groups, User access and Study access
  • Computer-generated Audit Trail
  • Clinical database version handling

PheedIt Advantages:

  • Full electronic CRF management
  • Native SAS database structure
  • Require no client-side installation