Clinical Data Management

Clinical Data Management Services Focusing on the Accuracy of Your Clinical Data

When It Comes to Clinical Trial Success, Data Integrity Is Key!

From database setup to cleaning, reporting, and final database lock, Almustat is committed to providing timely, accurate, and high-quality data using regulatory-compliant data management tools.

Whether you need clinical data management services as a stand-alone offering, part of a full-service package, or as part of a fully functional outsourcing solution, we can customize our services to meet your specific needs

END-TO-END CLINICAL DATA MANAGEMENT SUPPORT:

Using regulatory-compliant data management tools Almustat provides end-to-end clinical data management support from database set-up, through cleaning and reporting, to database lock.

With one single software solution, we deliver everything from eCRF implementation to clinical database oversight in all therapeutic areas.

CONVERSION OF DATA TO CDISC SDTM STANDARDS:

As CDISC Registered Solutions Provider we provide professional expertise for the conversion of clinical data to CDISC SDTM standards.

MEDICAL CODING:

Our Coder, ID-Code, is a web-based tool to classify safety-related data such as adverse events or concomitant medications – and supports standard MedDRA and WHODrug dictionaries.

 

End-to-End Comprehensive Clinical Data Management Services

  •  EDC set-up​ via ID-base™ powered by EvidentIQ ​ or Rave powered by Medidata
    • eCRF design​
    • Automatic edit checks​
    • Reporting​
    • Online Patient Profile​
  • CDASH compliancy
  • Data export to SAS according to CDISC SDTM ​standards​ (Pinnacle 21, DefineXML, Reviewer Guidelines)
    • Advanced Edit checks​
    • SAS Listings​
    • Patient Profile​
  • Data Review
  • External data import & reconciliation​ (SAS and/or EDC)
  • Medical coding (MedDRA, WHODrug)​
  • Pooling of databases for registration purposes
  • Consultancy

Comprehensive Services for Optimized Clinical Development Strategy

  • All of our clinical data managers have a scientific background, they are able to deeply understand each clinical study, from database set-up to database lock.
  • Our SDTM experts have the ability and experience in developing eCRF’s to CDASH standards and delivering data in STDM standards
  • Our team of data managers are committed to upholding a standardized, process-driven approach delivering timely, accurate and quality data.

BIOSTATISTICS AND DATA MANAGEMENT: COMBINED SERVICES ENSURING YOU MEET YOUR STUDY GOALS!

This session is focusing on the key clinical trial services of data management & biostatistics, and considerations for why there is increased value in having both of these services delivered by the same CRO.