FT. LAUDERDALE, Fla.—OmniComm Systems Inc., a provider of integrated electronic data capture (EDC) solutions, has joined forces with Logos Technologies, a clinical trial solutions provider, by integrating their systems to expand the use of EDC in Phase I to Phase IV studies.
Together, the companies will create an integrated EDC solution by combining OmniComm's TrialMaster trial management software with Logos's ALPHADAS data collection technology. TrialMaster uses Microsoft's .NET architecture to allow clinical trial sponsors and investigative sites to collect, validate, transmit and analyze study data, including patient histories, patient dosing and adverse events. The ALPHADAS Suite provides time-based data entry at the bedside, collection and integration of laboratory data, images, scans and bar-coded labeling to track samples from draw to dispatch.
OmniComm CEO Stephen Johnson says the collaboration is a response to client demand. "This is a classic example of one plus one equaling three," Johnson says. "For us, it allows us to lock up Phase I studies we otherwise wouldn't have, and for Logos, it allows them to expand their customer base beyond Phase I. We can't do what they do, and they can't do what we do, so together, we're giving our customers a lot of value we couldn't do alone."
While both companies provide data capture solutions, OmniComm's offering is more broad and applicable to all trial phases, whereas Logos' technology is more detail-oriented and focuses almost exclusively on Phase I trials, Johnson explains. OmniComm's customers wanted the ability to capture real-time data at the patient's bedside, but felt the company's time-based, choreographed data capture system didn't suit their needs. At the same time, Logos' technology had those capabilities, but lacked the back-end EDC support OmniComm's system had, Johnson said.
The interface will allow customers conducting clinical research in Phase I to take advantage of a clinical study management and fully mobile EDC system to capture data directly from the patient's bedside. This combined data may then be exported, archived and made available to clients in various reports and reporting formats.
For clients running Phase I to IV clinical studies, the combination will unify the capture, reporting, exporting and archival of clinical data into a common, cost-effective, Web-based user interface. The final warehouse for data may reside in SQL, Oracle Clinical database tables or in SAS.
Because the collaboration was driven by client and market needs, the two companies will continue to evaluate their partnership as they see response to the integration, says Giles Wilson, business and operations director for Logos.
"We recognize they have something we don't, and likewise for them," Wilson says. "We're partnering to provide better facilitation to our mutual clients. Because these types of things are market-driven, we will have to see how the integration works and is received."
Johnson says the collaboration will enhance EDC adoption in Phase I clinical trials. He points out that according to an EDC market report from Health Industry Insights, EDC adoption in Phase I trials is expected to more than double in the United States alone over the next two to three years.
"People have been adopting EDC in Phase II, III and IV trials, but for the most part, Phase I had ignored EDC, so all of the advantages EDC brings to late-phase trials were not being seen in Phase I trials," Johnson says. "The whole idea for any company is to get their drug through the pipeline as quickly as possible. I think we are going to get life-saving drugs to market more quickly—it's as simple as that."
Logos' Wilson agrees: "The need for real-time data capture in Phase I studies continues to increase. Drug development companies are looking for solutions that will produce faster access to data and earlier go or no-go decisions, while reducing costs throughout the whole Phase I process. The partnership between Logos Technologies and OmniComm now offers companies a way to truly benefit from EDC from the very onset of their trial through to database lock," he says.
Together, the companies will create an integrated EDC solution by combining OmniComm's TrialMaster trial management software with Logos's ALPHADAS data collection technology. TrialMaster uses Microsoft's .NET architecture to allow clinical trial sponsors and investigative sites to collect, validate, transmit and analyze study data, including patient histories, patient dosing and adverse events. The ALPHADAS Suite provides time-based data entry at the bedside, collection and integration of laboratory data, images, scans and bar-coded labeling to track samples from draw to dispatch.
OmniComm CEO Stephen Johnson says the collaboration is a response to client demand. "This is a classic example of one plus one equaling three," Johnson says. "For us, it allows us to lock up Phase I studies we otherwise wouldn't have, and for Logos, it allows them to expand their customer base beyond Phase I. We can't do what they do, and they can't do what we do, so together, we're giving our customers a lot of value we couldn't do alone."
While both companies provide data capture solutions, OmniComm's offering is more broad and applicable to all trial phases, whereas Logos' technology is more detail-oriented and focuses almost exclusively on Phase I trials, Johnson explains. OmniComm's customers wanted the ability to capture real-time data at the patient's bedside, but felt the company's time-based, choreographed data capture system didn't suit their needs. At the same time, Logos' technology had those capabilities, but lacked the back-end EDC support OmniComm's system had, Johnson said.
The interface will allow customers conducting clinical research in Phase I to take advantage of a clinical study management and fully mobile EDC system to capture data directly from the patient's bedside. This combined data may then be exported, archived and made available to clients in various reports and reporting formats.
For clients running Phase I to IV clinical studies, the combination will unify the capture, reporting, exporting and archival of clinical data into a common, cost-effective, Web-based user interface. The final warehouse for data may reside in SQL, Oracle Clinical database tables or in SAS.
Because the collaboration was driven by client and market needs, the two companies will continue to evaluate their partnership as they see response to the integration, says Giles Wilson, business and operations director for Logos.
"We recognize they have something we don't, and likewise for them," Wilson says. "We're partnering to provide better facilitation to our mutual clients. Because these types of things are market-driven, we will have to see how the integration works and is received."
Johnson says the collaboration will enhance EDC adoption in Phase I clinical trials. He points out that according to an EDC market report from Health Industry Insights, EDC adoption in Phase I trials is expected to more than double in the United States alone over the next two to three years.
"People have been adopting EDC in Phase II, III and IV trials, but for the most part, Phase I had ignored EDC, so all of the advantages EDC brings to late-phase trials were not being seen in Phase I trials," Johnson says. "The whole idea for any company is to get their drug through the pipeline as quickly as possible. I think we are going to get life-saving drugs to market more quickly—it's as simple as that."
Logos' Wilson agrees: "The need for real-time data capture in Phase I studies continues to increase. Drug development companies are looking for solutions that will produce faster access to data and earlier go or no-go decisions, while reducing costs throughout the whole Phase I process. The partnership between Logos Technologies and OmniComm now offers companies a way to truly benefit from EDC from the very onset of their trial through to database lock," he says.
