Specialists in data management since 1987, our high level of attention to detail combined with our well developed procedures and common-sense approach across various clinical trials over multiple countries, have earned Datapharm Australia a strong reputation for providing excellence in all data management processes.
As information management specialists, we can meet all your data management needs and are able to tailor our services to meet your budget.
Our data management specialists are highly experienced in handling medical and scientific data. All data is thoroughly reviewed by appropriately trained and experienced staff to ensure data integrity. All our data management processes are regulated according to closely controlled SOPs and in accordance with ICH GCP, FDA 21 CFR part 11 and CDISC/CDASH standards. These established data management systems can offer you significant time and cost savings.
Datapharm Australia team takes very seriously its obligation to protect the privacy, confidentiality and security of all information entrusted to us.
Our data management services include:
Designed by our experienced data management specialists using a well-established CRF library to capture essential data that are important for data analysis depending on each specific trial, protocol and required by regulatory agencies.
Patient diary i.e. paper-based diary or electronic diary (ePRO – electronic patient reported outcomes)
Any type of tracking reports can be produced and sent as regularly as required. Our highly trained project managers will manage each phase of your project to deliver superior results, on time and at an affordable price.
Regular updates of data listings can be produced so that a snapshot of the data can be viewed as required.
Data quality control (QC) is conducted in-house after each process to maintain data integrity and consistency.
MedDRA coding: Coding of adverse events and medical history in the latest version of MedDRA by certified MedDRA coders with medical background.
WHO DD coding: Coding of medications in WHO DD by experienced coders with medical and pharmaceutical background.