The Case Report Form (CRF) is the central tool used in clinical trials. It captures all required data for each patient during a clinical trial as defined by the clinical protocol. The quality of the CRF design is of key importance as mistakes can cause expensive re-work and compromise the validity of the data. PAREXELs experienced CRF design team have the skills to complete this key set up task to the highest quality, allowing the clinical trial to begin from a solid foundation.
Our CRF designers form a worldwide group and have representatives in the UK, Germany and the US. Our experienced team members design CRFs and eCRFs for all phases of clinical trials in a wide spectrum of therapeutic areas and indications from Acne to Zollinger-Ellison Syndrome.
PAREXEL maintains strong cross-functional cooperation between the CRF design team, Clinical, Medical, Data Management and Statistics. The well-established feedback system ensures that database design, ease of data entry and statistical output are equally considered during the creation of each CRF.
The CRF design group has created and maintained standard CRF pages for our sponsors. CRF pages for new studies from these clients can be readily adapted from libraries of standards to save time and cost. Alternatively, for new sponsors, the use of PAREXEL standard CRF pages allows for a streamlined CRF design and database set-up at PAREXEL.
The group has extensive experience of InDesign®; PageMaker and FrameMaker® and can use a variety of other software.
In addition to CRF design, we also offer our clients full-service printing coordination. We work with a select group of printing vendors to handle every aspect of the study’s printing requirements including:
- paper selection
- binder selection
- tab formatting
- back-printing
- graphics
- diary specifications etc.
Furthermore, the CRF Designer group may coordinate and track the shipment of the material to the investigational site.
CRF design can form part of a wider outsourcing agreement, we also offer stand-alone CRF design services. Click here for a CRF design enquiry.