Yardley, Pa.-based eClinical technology company Almac Clinical Technologies won $12 million in new clinical trial contracts in May. The company will be running a large global study enrolling 20,000 patients, the largest trial for Almac to date. The company said it has seen an increase in the size and intricacy of clinical trials, as well as small complicated trials using adaptive design techniques.
“We are able to handle these through our highly customizable and configurable IXR interactive voice and web response systems. We are also experiencing higher volumes of studies that fit our IXR Express offering, which provides flexible core module-based solutions that enable faster set-up times and lower costs for a web and phone solution,” said Almac’s business development director, Joe Cunningham.
During the 2008 Partnerships with CROs and EDC & Beyond Conference, held in Las Vegas in April, Fritz Haas, vice president of new products and services, spoke about the adoption of electronic data capture (EDC) reaching a "tipping point" in the industry.
"In the past, EDC was looked upon mainly as a solution for late stage trials involving large volumes of data or complex designs. Today, however, sponsors are adopting early stage methodologies such as translational medicine and 'learn and confirm,' which require data sharing between scientists and clinicians involved in early stage development from discovery through proof-of-concept in phase II," he said.
Almac also signed a new agreement with Boston-based biotech firm Biogen Idec for the use of Almac Diagnostics’ genetic extraction services being used in a phase II trial for gastrointestinal stromal tumors.
Julie Ranuio-Kelley, senior associate scientist for Biogen Idec, touted the benefits of using Almac's extraction sevices in discovering useful new development tools.
“This newly validated approach means that we can now access the full genetic information contained in our clinical trial samples. This will allow us to uncover biomarkers that will help us discover additional drug candidates and identify specific patient populations that will benefit from a particular treatment,” she said.