Case report form design
Datapharm Australia’s expert data management team with experience across a wide range of therapeutic areas and high level of attention to detail will custom-design your paper-based case report form (CRF) or electronic data capture (EDC) or ePRO systems to suit your trial, protocol and budget. Our CRF forms or system are efficient and cost-effective to build and the use of well-established library templates which have been refined over many years to create a high quality easy-to-complete CRF. More importantly, our CRF design is compliant with ICH GCP and CDISC/CDASH standards to facilitate data capture and statistical reporting so that your trial data can be submitted to any regulatory agency.
Electronic data capture (EDC) / Electronic CRF
Electronic data capture system (EDC), via eCRF, can appreciably enhance data quality, facilitate data review, and ultimately, shorten the duration of the trial. Utilising CDISC , FDA 21 CFR part 11 recommended standards and following ICH GCP guidelines, Datapharm Australia can build a user friendly eCRF tailored to capture the data that your trial requires.
Datapharm Australia has been in partnership with Merge Healthcare since 2010. Our data management team are certified to set up, deploy and manage eCRFs in Merge eClinical OS platform. Merge eClinical OS system can offer a wide range of tools such as electronic data collection, interactive voice and web response (IVR/IWR) or randomisation, electronic patient reported outcomes (ePRO) access, drug dispensing/shipping management, medical coding and laboratory/images upload to help manage different aspects of the trial.
The advantages of the EDC system include:
- Real-time access to eCRF data is beneficial for auditing site’s performance and more efficient study monitoring.
- Data trail – CFR 21 part 11 compliant.
- System time-out and unique usernames and passwords for users i.e. private and confidential.
- With in-built electronic validation checks, many data entry errors can be avoided, eliminating many unnecessary data queries, significantly improving efficiency and data input quality.
- Data can be exported, downloaded to various file formats e.g. csv, excel, sas, pdf, word, etc. as required.
- Quick access to data with ability to lock for interim analysis.
- Reporting tools available e.g. produce instant tracking reports to indicate data status.
Patient reported outcomes (PRO)
PROs are an important source of data that forms an integral component of many studies. Apart from standard paper-based PROs, using the latest technology, Datapharm can either design and build electronic patient reported outcomes (ePRO) via Merge eClinical OS platform or via our “in-house” web-based patient diary system which is simpler and more cost-effective.
Depending on your trial requirements, Datapharm Australia can design your ePRO so that your trial participants can provide their diary information via a PC, laptop, iPad, iPhone, etc. for clear and immediate data capture.