BioClinica - Global Clinical Trial Solutions. Real-World Results

Bio-Imaging Technologies and Phoenix Data Systems have joined forces to become BioClinica, delivering new value and a breakthrough in eClinical services like never before.

Bringing together the power of industry-leading medical image management with best-of-breed EDC, BioClinica gives you increased quality throughout the entire lifecycle of your clinical trial - all from an established partner you can trust.

With over 2,000 successful clinical trials in both imaging core lab and eClinical services, our team of experts knows how to help bring your drug or device to market in the most efficient way possible. We have experience in every phase of clinical trials and in a wide range of therapeutic areas, including Oncology, Cardiology, Musculoskeletal and Neurology. Our time-tested processes and total focus on quality ensure your success.

eClinical studies

Over 450 BioClinica employees currently manage more than 11,000 sites, with experience conducting more than 700 eClinical studies and processing and assessing over five million images. Our staff are highly accomplished, well-respected scientists and physicians who offer guidance as well as unprecedented access to a network of academic and medical opinion leaders worldwide. Our renowned team delivers expertise that you can count on to provide quality results, from every patient and every site.

Discover how the combined power of BioClinica can help you manage your next trial with greater efficiency and increased data access — all with less risk.

Imaging core lab services

As the world's leading independent imaging core lab (ICL), BioClinica offers a full suite of medical image management solutions for the lifecycle of your trial and for a wide range of imaging modalities. Our state-of-the-art, FDA-compliant core labs, located in the US and Europe, enable us to offer world-class capabilities to our clients across the globe. We are dedicated to ensuring efficient quality processes and delivering the highest level of service. We can help you manage all aspects of the imaging component of your clinical trial — from expert scientific consultation, study start-up and initiation, imaging and data capture, collection, image quality control and processing of image data, to expert blinded review and delivery of final results.

Medical image management solutions

It takes more than cutting-edge technology to make your clinical trial a success. You also need a partner with expertise you can count on. BioClinica has the unmatched operational process knowledge to support you throughout the clinical trial continuum. From study start-up to final export of the data, you'll work with therapeutic specialty project management teams that coordinate all aspects of your therapeutic image management. Our certified therapeutic radiology technologists and fully trained personnel have the extensive experience to assist your clinical team with any site training necessary and ensure timely and protocol-compliant image data.

BioClinica offers more expertise with our deep roster of collaborative consultants, which includes board-certified radiologists, oncologists, rheumatologists, cardiologists and other therapeutic specialists to ensure the highest quality independent review. Due to the high number of FDA submissions, we participated in a total of eight not-for-cause, study-specific audits that resulted in no 483s, and no findings. Additionally, we are 21 CFR part 11 compliant, and passed both FDA and MHRA inspections.

eClinical Services

BioClinica helps you get the most from your clinical data by combining best-in-class technology with expert data management and experience in more than 700 electronic trials to date. Our trusted eClinical solutions have delivered speed and efficiency to our clients around the world for over 12 years.

At BioClinica, we take a different approach to EDC services. Unlike other vendors, we don't make our clients solely responsible for getting quality results from the technology. Instead, we provide clinical expertise and manage the technology on your behalf. There's no need for considerable resources or IT investments, and no learning curve or lengthy training. We provide everything you need to run a successful trial, from forms and edit checks, to reporting and coding software. And we have experience in a variety of major therapeutic areas, including Oncology, Cardiology, Musculoskeletal and Neurology, to help manage studies of any therapeutic indication. We also offer a wide range of clinical trial services, making it easy for you to conduct your study with greater efficiency.

Electronic data capture

BioClinica's electronic data capture is second to none in functionality and performance. Our technology adapts to your specific trial, maximises data quality and lets you see the results of your trial faster than conventional methods:

• Our EDC technology is flexible and easy-to-use and integrates easily with your other clinical processes and technology applications
• Our proprietary EDC platform can be deployed for standard web access, in a true eSource configuration and can accommodate both wired and wireless data entry devices
• Real-time analytics make your data instantly available to view or report, enabling you to visualise your milestones and metrics in real time
• Our EDC solutions can be tailored to work seamlessly with your CRO of choice, while still housing all your data and metrics in one place and keeping you in control of your trial
• If you're using our imaging core lab services, we can fully integrate all your reports and provide common data sets to keep your clinical and imaging data connected and easily available

Customised clinical trial solutions

BioClinica provides a complete suite of customised clinical trial solutions based on the unique needs of your trial:

• BioClinica Express™
• BioClinica IVR™/IWR™
• BioClinica Reportal™
• Full Service EDC
• Data Management
• Medical Coding

Contact:
Headquarters (General Information)
United States
826 Newtown-Yardley Road
Newtown, PA 18940
Tel: +1 267 757 3000
Fax: +1 267 757 3010

901 East 8th Avenue
Suite 201
King of Prussia, PA 19406
Tel: +1 484 928 6000
general@bioclininca.com

Europe
BioClinica, B.V.
Schipholweg 117
2316 XC Leiden
The Netherlands
Tel: +31 71 524 8660

BioClinica, S.A.S.
60 Avenue Rockefeller
F-69008 Lyon, France
Tel: +33 4 26 23 05 05

For study related questions please contact our help desk:

Toll-free from the US and Canada:
Tel: +1 888 ASK BIO2 (1-888-275-2462)
Email: helpdesk@bioclinica.com
Fax: +1 267 757 3353

Sales, product inquiries and general assistance:

Tel: +1.484.928.6000
Fax: +1.484.928.6001
Email: info@bioclinica.com

Help desk / technical support:

Tel: +1 866 405 1184
Email: helpdesk@bioclinica.com

Sales:

For information on sales and marketing, contact us at:

European Sales:

Dr. Klaus Noever (M.D.)
Vice President of Business Development and Clinical Affairs, Europe and Japan
Schipholweg 117
2316 XC Leiden, the Netherlands
Tel: +49 76 23 796246
sales@bioclinica.com

United States Sales:

Mark Endres
Vice President of Sales
826 Newtown-Yardley Rd.
Newtown, PA 18940
Tel: +1 267 757 3038
sales@bioclinica.com

www.bioclinica.com