Clinical Blog
There are a few cloud based ECM products out there. Alfresco provides cloud-based usage solutions that are smaller, more scalable solutions. Escort Viva is a giant in this space; They have been the front runner and have been providing a compliant cloud solution. Box and Drop Box provide cloud-based ECM solutions, but they are not Part 11 compliant and do not follow GxP standards at this point, will in the future. Ideally, once they are compliant, they can be used for business operations. The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large…
One of the challenges is the complex legacy architecture. There is an IT investment cost that generally can drive into the millions. Oftentimes, companies do not want to consider large content management solutions because they can be expensive. Nowadays, the average number of years it takes for ECM solutions to be fully implemented is somewhere between seven to nine years. Oftentimes, companies will go through personnel changes before the implemented solution is fully deployed. The IT investments in this area are quite considerable. Take time to consider as many scenarios as possible when choosing an ECM platform, as these systems…
Some of the tools you can use to help with Enterprise Content Management (ECM) implementation are project governance charts, project timelines, and responsibility matrices. Some of the other tools you can use are file sync and share solutions or anything to do with collaboration. Everything seems to be on the Cloud and externalized nowadays, so things like SharePoint 365 and VoxUltra provide external collaboration that will really help you with your implementations across any type of ECM implementation. The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology,…
There is no standard timeline for deploying an Enterprise Content Management (ECM) system. A while back, there was a CRO that was implementing an ECM system enterprise-wide and they were trying to over complicate it. It took 15 to 18 months and never got the completion on it. When the company looked back and revamped their costs to do a second attempt, they were able to do it in about three months. They decided they were going to use the DIA eTMF guidance to ensure that they could do it and just made some minor changes to the configuration. It…
If you have a Contract Research Organization (CRO) that is managing and hosting your content and you're accessing their content management solution, the responsibility is on the CRO to have a validated compliance content management solution for your content. However, you have to do due diligence and close your vendor auditing practices, your vendor management processes, and your SLA with your CRO to ensure that you've done proper due diligence to make sure that they are properly managing your content. The burden is effectively on the CRO, however you have to do your due diligence to ensure that you're auditing…
Clinical Enterprise Content Management (ECM) solutions can be leveraged in many different ways, which is one of the big advantages. ECM systems can be leveraged for SOP management, regulatory submissions, regulatory affairs, records information management, as well as by commercial and manufacturing. To have a comprehensive content management solution that goes across all areas of a pharma or biotech CRO. And, there are many companies that implement stand-alone solutions for each of their business units or content management solutions which then drive up costs of ownership because they're implementing various solutions that don't end, and you've got to have support…