Proper management of patient data has become an increasingly sensitive issue with the advent of Good Clinical Practice (GCP), 21 CFR Part 11, and HIPAA. In addition, the Food and… read more →
Clinical trials are increasingly being conducted on a global scale, with the potential for variability of workflow processes. A web based electronic data catpure (EDC) system is critical to effectively… read more →
When validating any eClinical system (used to collect data submitted to the FDA) regulations regarding electronic records and electronic signatures (FDA 21 CFR Part 11) require documented evidence that the… read more →
TGA is stepping up its oversight of medical device trials and we are likely to experience an increase in site audits. Historically, Australian sites have been audited more readily by… read more →
Conducting a clinical trial is an incredibly labour intensive operation, with a large proportion of the clinical trial budget attributed to the costs associated with verifying source data against the… read more →
Over the past few years Australia and New Zealand have become a hotspot for overseas companies to conduct clinical trials. The number of Medical device clinical investigations registered with TGA… read more →
Your early phase trial is crucial. You can’t just rely on anyone to monitor your trial, and the inexperience and turnover of staff in the larger CROs is worrisome. Choosing… read more →
There are many costs associated with running a clinical trial, and clinical trials are fundamentally extremely labour intensive. Data needs to be collected, recorded, verified, queried and then errors need… read more →
In Australia, there is no regulatory requirement for your study to collect data using an EDC, however all clinical data must comply with the Note for Guidance on Good Clinical… read more →
When beginning a clinical trial the sponsor needs to decide whether to use paper case report forms (CRFs) to collect study data or to use an electronic data capture (EDC).… read more →
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