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 Drug Administration (FDA) has raised the standard for what constitutes satisfactory pharmacovigilance. Drug safety has consequently become an ongoing process which begins earlier and ends […]

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 work cross-organizationally, over a large geography. Most importantly, because the solution is web-enabled, information is easily accessible from anywhere, at any time.

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 eClinical system does what it was intended to do and that it does so accurately and consistently. In Australia the ICH-GCP guidelines are similar in […]

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 FDA, if they’re participating in IDE trials or research supporting PMA submissions. One of the most common findings of an FDA audit are violations pertaining […]

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 study case report forms (monitoring). With the trend towards electronic source records, monitors now have the ability to source data verify clinical trial data without […]

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 has risen by a steady 7% since 2005. There are several reasons why companies, especially US sponsors, are going “Down Under” to conduct their clinical […]

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 a company that has the resources to accommodate your project, yet is small enough to remain flexible is vital. In the end, you want a […]

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 to be amended before the CRFs are signed. This process takes time, and time costs money. An EDC reduces the number of total queries, has […]

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 Practice (CPMP/ICH/135/95) annotated with TGA comments, for data collection. These ICH-GCP guidelines are similar in nature to the FDA Code of Federal Regulation Number 21 […]

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). The primary consideration for most organisations is up front costs. At Mobius Medical, we believe that basing your decision solely on up-front costs may not […]