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Merge Healthcare Incorporated, provider of clinical systems, announced that Datapharm Australia Pty Ltd. has selected Merge's eClinical OS(TM) solution to bring EDC in-house and provide control of electronic case report form (eCRF) creation and mid-study adjustments.
"We've seen an increase in the number of our clients' studies requiring EDC. Previously, we outsourced EDC projects to a third party vendor to handle eCRF setup," explained Dr. Helen Allars, Managing Director at Datapharm Australia. "We found that we spent more time and resources managing this process and dealing with support issues. This approach also lacked the flexibility and control for mid-study changes."
In 2010, Datapharm began an EDC vendor evaluation, which included 14 vendors who could offer in-licensing of software for use across an enterprise, also referred to as technology transfer. Datapharm's evaluation criteria consisted of a comprehensive suite of EDC tools, time to deployment, and overall costs associated with technology transfer.
"eClinical OS provided all the EDC features we needed -- such as 21 CFR Part 11 and CDISC compliance, Hybrid/DDE, CRF library, reporting, data upload and exporting, medical coding, and monitoring tools -- as well the opportunity to add patient reported outcomes, interactive response,randomization and inventory management if a particular study called forit," continued Allars.
"Companies that are bringing our solution in-house are doing so because they recognize that eClinical OS provides a strategic tool in their pursuit to provide more efficient, cost-effective clinical trials services," said Justin Dearborn, President of Merge Healthcare. "Datapharm has taken the first critical step to yield the greatest efficiencies and financial rewards of using our eClinical technologies to simplify and accelerate the way they perform clinical trials."
Merge eClinical OS is a unified platform aiming to deliver end-to-end study support. Clinical trial capabilities can be mixed and matched to build a solid foundation for each trial environment, and features and services can be added as needed, directly from within the system. As a single, web-based solution, it aims for the flexibility to support trials in any phase, and captures any type of data, from any source, over any modality. Merge eClinical OS also has the scalability to grow if a trial increases in size, number or complexity.