Durham, NC, January 29, 2014 - Clinverse, Inc., provider of the first end-to-end technology solution that automates the financial lifecycle of global clinical trials, announced today that Chelsea Therapeutics has implemented ClinPay® to automate investigator payments for a complex, global trial. The trial, known as Study 401, is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study of investigational drug NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, being studied for the treatment of symptomatic neurogenic orthostatic hypotension (nOH).
Already working with a top-ranked clinical research organization (CRO) to manage its clinical development program, Chelsea chose to implement ClinPay for its global study to automate the entire investigator payment process. The company recently announced that it has begun dosing patients and will be screening up to 500 patients across 100 sites throughout the U.S., Canada, and Europe.
"Given the size and reach of our trial, it was important for us to work with a payment solution provider with global capabilities," said Tim Maness, Senior Director of Finance and Corporate Controller of Chelsea Therapeutics. "The Clinverse team was able to seamlessly integrate ClinPay with our CRO provider and the necessary clinical systems, allowing our CRO to focus their efforts on the important clinical activities required of this trial."
During the start-up phase, Clinverse will work closely with Chelsea to identify and load each unique site contract across the study's 100 sites, leveraging ClinPay's proprietary contract meta language (CML) to automatically convert contracted payment terms into actionable items. In addition, the system's open application programming interface (API) provides seamless integration with Chelsea's EDC provider. When data is captured by their EDC system, transactions are automatically triggered in ClinPay and routed to the appropriate approver for payment directly from ClinPay. With these capabilities, sponsors can expect to reduce costs typically associated with the manual efforts of both the sponsor and the CRO required to pay sites and other vendors by as much as 30- 40%.
"Because of the nature of clinical trials and the uniqueness of each trial, Clinverse works closely with our clients to set up, configure, and rigorously test through a full UAT process. Every ClinPay implementation ensures that transactions are configured to reflect the negotiated site contracts and that payments are properly routed," explained Jeff Rogers, Chief Commercial Officer of Clinverse. "Once ClinPay is live, all the client needs to do is simply leverage the automation that has been established and let technology take care of the rest. ClinPay automates the complete financial lifecycle within the eclinical process, including contract term translation, payment automation, amendment management, accounting, and reporting."
About Clinverse, Inc. Clinverse, Inc. architected the industry's first end-to-end technology solution that automates the financial lifecycle of global clinical trials. Powered by our secure technology platform, our solution standardizes clinical trial finance and manages millions of financial transactions across the globe, including clinical site payments. Used by leading BioPharma companies, our clients benefit from reduced workload, time, and costs gained through automation and unprecedented transparency and workflow. For more information, please visit http://www.clinverse.com.
This press release contains forward-looking statements regarding future events including our intention to pursue the development of Northera. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that the FDA will not approve the resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete any additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.
Press Contact:
Jennifer Plumer
Clinverse, Inc.
Durham, NC
919.745.8848
http://www.clinverse.com
Already working with a top-ranked clinical research organization (CRO) to manage its clinical development program, Chelsea chose to implement ClinPay for its global study to automate the entire investigator payment process. The company recently announced that it has begun dosing patients and will be screening up to 500 patients across 100 sites throughout the U.S., Canada, and Europe.
"Given the size and reach of our trial, it was important for us to work with a payment solution provider with global capabilities," said Tim Maness, Senior Director of Finance and Corporate Controller of Chelsea Therapeutics. "The Clinverse team was able to seamlessly integrate ClinPay with our CRO provider and the necessary clinical systems, allowing our CRO to focus their efforts on the important clinical activities required of this trial."
During the start-up phase, Clinverse will work closely with Chelsea to identify and load each unique site contract across the study's 100 sites, leveraging ClinPay's proprietary contract meta language (CML) to automatically convert contracted payment terms into actionable items. In addition, the system's open application programming interface (API) provides seamless integration with Chelsea's EDC provider. When data is captured by their EDC system, transactions are automatically triggered in ClinPay and routed to the appropriate approver for payment directly from ClinPay. With these capabilities, sponsors can expect to reduce costs typically associated with the manual efforts of both the sponsor and the CRO required to pay sites and other vendors by as much as 30- 40%.
"Because of the nature of clinical trials and the uniqueness of each trial, Clinverse works closely with our clients to set up, configure, and rigorously test through a full UAT process. Every ClinPay implementation ensures that transactions are configured to reflect the negotiated site contracts and that payments are properly routed," explained Jeff Rogers, Chief Commercial Officer of Clinverse. "Once ClinPay is live, all the client needs to do is simply leverage the automation that has been established and let technology take care of the rest. ClinPay automates the complete financial lifecycle within the eclinical process, including contract term translation, payment automation, amendment management, accounting, and reporting."
About Clinverse, Inc. Clinverse, Inc. architected the industry's first end-to-end technology solution that automates the financial lifecycle of global clinical trials. Powered by our secure technology platform, our solution standardizes clinical trial finance and manages millions of financial transactions across the globe, including clinical site payments. Used by leading BioPharma companies, our clients benefit from reduced workload, time, and costs gained through automation and unprecedented transparency and workflow. For more information, please visit http://www.clinverse.com.
This press release contains forward-looking statements regarding future events including our intention to pursue the development of Northera. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that the FDA will not approve the resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete any additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.
Press Contact:
Jennifer Plumer
Clinverse, Inc.
Durham, NC
919.745.8848
http://www.clinverse.com
Source: Global Communication Leader., Inc.
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