Data management

Your organisation can benefit from our strong background and proven experience in clinical data management services for clinical trials, which is supported by our fully validated, custom-built clinical data management system (DCDMS).

Data is supplied in CDISC-compliant formats to support the acquisition, exchange, submission and archiving of clinical research data and metadata.

Dianthus Clinical Data Management System

The DCDMS is built using Microsoft Access and contains all the features you would expect to ensure the validity of data entered, such as duplicate data entry, automatic generation, tracking and resolution of data queries and audit trails.

The application is customised by Dianthus professionals and is not reliant on any external helpdesk to solve any issues that may occur. This allows smooth completion of every data management project to our client’s exacting standards.

In addition, client’s can also take advantage of our considerable experience in designing CRFs for use in clinical trials.

Your organisation receives a responsive data management service that fits in with your needs, adapting to ever-changing and often tight deadlines.

These data management services are fully compliant with Good Clinical Practice (GCP) and ensure the data from your clinical trials are managed to the highest professional standards.

CDISC

We are very familiar with CDISC standards, and can make sure that our work is compliant where appropriate. We can prepare case report forms (CRFs) in CDASH compliant format, and supply all raw data from our statistical analyses in SDTM and ADaM formats.

Please see the CDISC website if you’re not familiar with these standards and the benefits that standardisation can bring to processing clinical trial data in an efficient manner.

In addition to creating our own data in CDISC-compliant formats, we can also convert existing legacy datasets to CDISC structures. Please contact us for more details.

Case report forms

The case report form (CRF) is one of the most important tools for your clinical trial to ensure that the correct data are collected to generate meaningful analysis.

Our data management and medical writing team collaborate to:

  • capture all the important data for each patient during your clinical trial according to the protocol
  • consider the database design and statistical output to ensure the data captured is of the highest quality
  • consider the perspective of the person completing data entry to allow ease of use to speed up processes and minimise queries
  • prepare the CRF in CDASH compliant format
  • design the CRF using your templates and requirements