Medtentia International and clinicalprojects international Tap BioClinica for Express EDC, Data Management, and Centralized Imaging Reads
International Experience, Flexibility, and Speed to Support
Innovative Cardiac Device Research
BioClinica®, Inc. (NASDAQ: BIOC), a global provider of
clinical trial management solutions, today announced an agreement for
BioClinica Express EDC, data management, and imaging core lab services
with Finnish company Medtentia International, in partnership with the
contract research organization (CRO) clinicalprojects international
(CPI). Medtentia International Ltd. is a medical technology company
which develops solutions for mitral valve repair based on its
proprietary helix ring concept. Medtentia’s technology has the potential
to reduce the invasiveness, operation time and morbidity associated with
mitral valve repair operations.
Medtentia is the latest European customer to select BioClinica eClinical
and Imaging Core Lab offerings. BioClinica services will support
Medtentia’s multi-country, multi-year study of a medical device for
mitral valve (heart) repair. "We awarded this clinical trial to CPI and
BioClinica based on the excellent feedback we received from their
reference clients,” commented Olli Keranen, CEO of Medtentia. “We were
already familiar with BioClinica’s Imaging Core Lab solutions and wanted
to outsource EDC and DM to a stable global eClinical vendor. We are
confident that both companies’ reputations for customer focus and
respective strengths will well serve the needs of an innovative medical
device company like Medtentia."
Based in Bonn, Germany, CPI is focused on the planning and execution of
Phase I-IV as well as post-marketing studies for innovative medical
devices, combination products and (Bio)Pharmaceuticals. “We are
delighted that Medtentia has entrusted us with their trial and look
forward to another successful collaboration with the BioClinica team,”
said Jörg Breitkopf, Managing Director of CPI. “BioClinica has a strong
service and technology reputation among medical device companies. Our
partnership will provide Medtentia with the utmost in clinical trial
support.”
"BioClinica’s fresh and more cost-efficient approach to clinical trial
support is currently driving unprecedented sponsor and CRO partnership
growth across both eClinical and Imaging Core Labs solutions,” said Mark
Weinstein, CEO of BioClinica. We continue to expand our team, especially
in Europe, adding to our experience and global reach, and are pleased to
have been selected to help support this important cardiac device
research.”
Follow BioClinica on the Trial Blazers blog at http://info.bioclinica.com/blog,
and on twitter at http://twitter.com/bioclinica.
About Medtentia International Ltd Oy
Medtentia International Ltd Oy is a clinical-stage medical technology
company developing novel mitral valve therapy products based on the
company’s proprietary helix technology. The company, based in Helsinki,
Finland, is backed by leading Nordic venture capital funds. Additional
company information can be found at www.medtentia.com.
About CPI
clinicalprojects international GmbH provides professional CRO services
for manufacturers of medical devices, combination products and
biopharmaceuticals. Since CPI’s foundation in 2007, clients have turned
to it for a range of clinical research support from the completion of
individual tasks to full-project outsourcing. CPI has been involved in
numerous medical device studies in various indications, most recently in
cardiology, neuromodulation and pain. See more at http://www.clinicalprojects.de.
About BioClinica, Inc.
BioClinica, Inc. is a leading global provider of integrated,
technology-enhanced clinical trial management solutions. BioClinica
supports pharmaceutical and medical device innovation with imaging core
lab, internet image transport, electronic data capture, interactive
voice and web response, clinical trial management and clinical supply
chain design and optimization solutions. BioClinica solutions maximize
efficiency and manageability throughout all phases of the clinical trial
process. With over 22 years of experience and more than 2,500 successful
trials to date, BioClinica has supported the clinical development of
many new medicines from early phase trials through final approval.
BioClinica operates state-of-the-art, regulatory-body-compliant imaging
core labs on two continents, and supports worldwide eClinical and data
management services from offices in the United States, Europe and Asia.
For more information, please visit www.bioclinica.com.
Certain matters discussed in this press release are “forward-looking
statements” intended to qualify for the safe harbors from liability
established by the Private Securities Litigation Reform Act of 1995. In
particular, the Company’s statements regarding trends in the marketplace
and potential future results are examples of such forward-looking
statements. The forward-looking statements contained in this press
release are based on our current expectations, and those made at other
times will be based on our expectations when the statements are made.
The forward-looking statements include risks and uncertainties,
including, but not limited to, the consummation and the successful
integration of current and proposed acquisitions, the timing of projects
due to the variability in size, scope and duration of projects,
estimates and guidance made by management with respect to the Company’s
financial results, the demand for our services and technologies, growing
recognition for the use of independent medical image review services,
trends toward the outsourcing of imaging services in clinical trials,
realized return from our marketing efforts, increased use of digital
medical images in clinical trials, expansion into new business segments,
backlog, critical accounting policies, regulatory delays, clinical study
results which lead to reductions or cancellations of projects, and other
factors, including general economic conditions and regulatory
developments, not within the Company’s control. The factors
discussed herein and expressed from time to time in the Company’s
filings with the Securities and Exchange Commission could cause actual
results and developments to be materially different from those expressed
in or implied by such statements. The forward-looking statements
are made only as of the date of this press release and the Company
undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstance. You should
review the Company’s filings, especially risk factors contained in the
Form 10-K and the recent Form 10-Q.