SpineMark Corp., a medical
management company that is building a network of Spine Centers of
Excellence to support and connect physicians, facilities and medical device
companies in order to provide patients the best spine care, announced
that the company will demo the SpineMark Clinical Operating System at the
22nd Annual Meeting of the North American Spine Society (NASS). The system
will be available to be viewed in the SpineMark Booth #1452 and will be
launched by the end of 2007.
The SpineMark Clinical Operating System is an integrated suite of
clinical trial management applications under development that will benefit
sponsors using SpineMark CRO Management and physicians partnering with
SpineMark as investigational research sites. It is the only integrated
system of its kind that has been designed specifically for spine. Currently
the system is made up of a kiosk, which provides a HIPAA compliant,
electronic data capture interface for patients to fill in health status
forms. The second component is a clinical trials management system (CTMS),
which has the ability to electronically standardize, capture and process
clinical data. The CTMS is used for patient scheduling, tracking, budgeting
and billing.
"While other tools are available, the SpineMark Clinical Operating
System is the first to be designed specifically for spine and is able to
integrate the entire clinical trial process from patient input to study
outcomes to payor reimbursement," said Marcy Rogers, president and CEO of
SpineMark Corp. "As outcomes data is becoming increasingly more important
in support of payor reimbursement, our system will help sites collect and
process this information electronically."
"From our experience beta testing the SpineMark Clinical Operating
System, we are impressed with the ease in collecting and retrieving patient
information and study data compared to current paper collection forms,"
said Scott Blumenthal, M.D., president of SpineMark CRO at Texas Back
Institute. "Being able to capture the data electronically has resulted in
fewer errors and more timely reporting back to our sponsors. This will
reduce time delays in the clinical trial process."
Delays in clinical trials are well-documented within the medical device
industry. In a recent industry survey, collection of case report form data,
source document verification and resolution of data discrepancies accounted
for more than half (55%) of the delays in clinical trials(1). New solutions
such as the SpineMark Clinical Operating System will help address these
issues.
The SpineMark Clinical Operating System will be launched by the end of
the year with the addition of case, outcomes and performance management,
image transfer via PAC systems, management of clinical trial business
functions and decision support applications. These applications will create
efficient communication of clinical protocols, patient data and regulatory
events to produce seamless clinical data flow and efficient clinical trial
management. In 2008, a handheld data capture application will be integrated
as well.
"Efficient collection and communication of clinical trial data is
critical for the advancement of spine care treatments," said Mr. Alan
Donald, president of SpineMark CRO Management Inc. "The SpineMark Clinical
Operating System will provide clinical trial sponsors, physicians and
institutions with the technology to manage every aspect of clinical trials,
including patient monitoring and data analysis to support
pay-for-performance payor reimbursement."
About SpineMark Clinical Operating System
SpineMark Clinical Operating System is the first advanced technology
specifically designed and integrated for spine clinical trial management.
The system fully supports patient data, study outcomes and payor
reimbursement to improve patient care, advance new products and create
profitable healthcare institutions. By the end of 2007, the SpineMark
Clinical Operating System will be available to sponsors who elect SpineMark
CRO Management and physicians partnering with SpineMark as investigational
research sites.
About SpineMark
SpineMark Corporation, headquartered in San Diego, combines the
clinical, business development, contracting, marketing and research
expertise to establish Spine Centers of Excellence. Additionally,
SpineMark's subsidiary, SpineMark CRO Management Inc., conducts national
FDA trials at the Centers of Excellence. Formed as a joint venture between
Texas Back Institute Holdings and Management Technology Resources,
SpineMark is dedicated to unite all of the necessary experience and
expertise under the management of recognized leaders in both the business
and medical world of spine care. To learn more about SpineMark, visit:
spinemark.
(1) CenterWatch; Parexel Pharmaceutical International Sourcebook; 2000;
Lehman Brothers; interviews, McKinsey analysis.
SpineMark Corporation
spinemark