In the ever-evolving landscape of clinical trials, the need for a Clinical Trial Management System (CTMS) that is configurable, flexible, and scalable cannot be overstated. In this era of precision medicine and fast-paced research, organizations require a CTMS solution that can adapt to their unique protocols, processes, and changing requirements. But what sets apart an […]
Pharmaceutical companies have been operating in the cloud for over a decade. For clinical trials, EDC (Electronic Data Capture) was the first of the eClinical systems to move into the cloud. Cloud-based CTMS (Clinical Trial Management Systems) have had a slower cloud adoption, but in the last several years, pharmaceutical companies have been pushing for […]
Recently I wrote a blog about the steps required to successfully identify and select a clinical systems vendor that will truly deliver against your needs. Here is the recap of that post: Write a business case Collect detailed requirements Write a clear RFI Quickly narrow down your list of candidates Host some dog & pony […]
The systems used in clinical R&D (or commercial, or HR, or finance…), like everything else in the world (people included), eventually grow old and stop working the way we’d like them to. Fortunately, these systems can be replaced – though not necessarily any more cheaply or easily than your Uncle Irwin’s hip. Done the right […]
In today’s environment, it is almost certain that the pharmaceutical industry will continue the downsizing of drug development operations. In doing this, they will place an ever-greater reliance on strategic CRO alliances and collaborative technologies. As sponsors increase their reliance on CROs, the need for better collaboration and more transparency will also increase. Data Collection In […]
At Intrinsic, we’ve been implementing Clinical Trial Management Systems (CTMSs) and have been part of the eClinical evolution since Part 11 was drafted back in 1997. During that time, we’ve had to answer a lot of questions, starting with, ‘Do I have to validate my CTMS?’. Over the years that question was replaced with, ‘Do […]
In the pharma industry, we see the same problem over and over again. That problem is massive amounts of data, stored in different formats and locations, which people are unaware exists. A great first step to solving these data problems is using document libraries in SharePoint with metadata fields to store documents/files. Identifying and tagging […]
Are you a clinical project manager and still using static visuals when interactive data visualization is available for clinical trial data? What is data visualization? I’m glad you asked. Data visualization is the presentation of information in a graphical form such that you can glean insights or make decisions. It helps one communicate information effectively, […]
Capacity planning, demand forecasting, portfolio reviews, prioritization processes, budgeting processes, etc. are all vital to a biotech and pharma business. Tens of millions, if not hundreds of millions, of dollars are on the line when making decisions about people, projects, programs, therapeutic areas, and acquisitions.
If there was one problem you could fix with clinical trials, what would it be? Would it be better supply chain? Better clinical trial software? More qualified clinical trial personnel, such as clinical project managers? Sure, all of these are serious challenges we face day in and day out, but many clinical team members would […]