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 can take up to a year, but if they use a good process it can be faster. USDM Life Sciences is working with a small company right now, and they're implementing an eTMF taxonomy in about a month and a half or so -- the work can vary. It depends on how far you want to deviate from the DIA model or if you even want to use it. Most companies choose to use the DIA model if at all possible.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

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