If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits. This concept of Kits can be generously used to distribute and assign blinded Kits, like Open-label Rescue medication, Run in Kits.
The introduction of European Medical Device Regulation (EUMDR 2017/745) gives great importance to the end user to assist with the safe and proper use of a medical device(s). The EU MDR and other UDI-type of regulations is causing more and more medical device companies to revisit their labeling processes.
The advantages of the D to S is multi faced for Subjects, Sites, CROs and Sponsors. We recognized the increasing significance of D to S which inspired us the build this features into our system. Our D to S is build to overcome unique challenges that come with this model.
To account all the supplies of Clinical Trial is a regulatory requirement. Traditionally people used to use paper based or Excel based tracking of the Supplies. This is tedious, time consuming and error prone. DDi has built a robust and plug and play Supplies Accountability module into its mIRT.
EU MDR is turning digitization on its head. This new regulation, which goes into effect May 26, 2020, is inducing digitization back to the forefront. EU MDR aim to enhance medical device safety and effectiveness and to realize this, the new regulation requires the use of eIFU.
If you know your risks, I’m sure you or your teams manage them well (with KRIs or thresholds or logs or trackers). Question is what are you doing about the remaining 80% of risks. Most companies leave this key part to either untrained teams or vendors (and some of vendors doesn’t know risk management except to update a risk log before audits).
Unfortunately, most sponsors and CROs use multiple applications to manage their clinical studies. Integrating multiple applications may be challenging for example reporting through multiple apps, managing data & content across systems, limited collaboration, ease of use, Compliance with standards and the list goes on.
Clinical trials are more complex than ever and a robust, reliable & cost efficient clinical supply strategy is vital more than ever before. The number and complexity of issues affecting supply chains have also grown to include costly comparative drugs, intricate protocols, delicate investigative compounds, adaptive clinical trials
To enter into a market, biopharmaceutical companies should have information of local regulations irrespective of the type of drug. Tracking the local regulations of semi and non-regulated markets are the biggest challenges for an affiliate as there would be certain changes expected frequently in regulatory world.
Companies who did large implementations have all noticed their costs and timelines doubled than what is budgeted initially. Yet, PwC's 2017 effectiveness benchmark report found that users spend half their time focused on mundane, repetitive tasks of gathering data from various systems. This led to many of the systems reaching the point of diminishing returns.
Is your team still using Excel sheets, or other functional teams tools (such as registration trackers or ERP) to manage your global regulatory Health Authority / Notified Body compliance activities? Learn why these tools pose either compliance or business risks if you manage your regulatory activities.