Clinical Trial Data: Time, Cost & Quality

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 […]

Are Your Clinical Trial Data Collection Methods Compliant?

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 […]

Starting a Clinical Trial: Paper or EDC?

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 […]

OpenClinica Web Based EDC

At Mobius Medical we primarily use OpenClinica open source EDC software. This means no licensing fees, you pay only for the database build and validation. We also provide a hosted solution, further reducing your costs. Contact us now for a demo! OpenClinica is powerful, industry leading open source software for capturing and managing clinical trial […]

What is an Electronic Data Capture (EDC) system?

An Electronic Data Capture (EDC) is a computerized system designed for the collection of clinical data in electronic format for use in clinical trials. EDC systems are used in all aspects of clinical research, from early-phase research to late-phase (phase III-IV) studies, pharmacovigilance and post-market safety surveillance. An EDC can increase the data accuracy and […]

1 3 4 5