eclinical Services Predictable Pricing Full Service EDC Phase I-IV Sophisticated Edit Checks Drug Supply Chain Forms Library Data Collection Services

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1 eclinical Services Predictable Pricing Full Service EDC Phase I-IV Sophisticated Edit Checks Data Collection Services Drug Supply Chain Forms Library Real-time Data Access Clinical Data Management Electronic Data Management

2 A world of solutions.

3 Sophisticated Edit Checks Forms Library Clinical Data Management Predictable Pricing Phase I-IV Real-time Data Access Full Service EDC Bio-Imaging Technologies and Phoenix Data Systems have joined forces to become BioClinica, bringing together clinical trial medical image management and EDC to deliver new value and a breakthrough in eclinical services. With 30 years of experience and over 2,000 successful clinical trials, 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. At BioClinica, we take a different approach to clinical trials. Unlike other vendors, we don t make the customer solely responsible for getting quality results from the technology. Instead, we provide clinical expertise and manage the technology on your behalf so 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. We also offer a wide range of services including Full Service EDC that allows you to outsource all of your data management responsibilities making it easy for you to run your trial with greater efficiency. 3

4 A world of technology. By combining best-of-breed technology with expert data management and experience in more than 700 electronic trials, BioClinica helps you get the most from your clinical data. Our trusted approach to EDC has delivered speed and efficiency to our clients around the world for over 12 years.

5 Predictable Pricing Clinical Data Management Real-time Data Access Full Service EDC Phase I-IV Proven EDC technology you can rely on. BioClinica s electronic data capture is second to none in functionality and performance. Our technology adapts to your specific trial, maximizes data quality and lets you see the results of your trial faster than conventional methods. Because our EDC technology is flexible and easy-to-use, it integrates easily with your other clinical processes and technology applications. BioClinica s proprietary EDC platform can be deployed for standard web access and in a true esource configuration, and can accommodate both wired and wireless data entry devices. Real-Time Analytics also make your data instantly available to view or report, enabling you to visualize your milestones and metrics in real time. We can even tailor our solutions to work seamlessly with your CRO of choice, while still housing all your data and metrics in one place and keeping you in control With BioClinica you ll get: of your trial. And 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. Faster start-up Flexible, proven technology Better protocol and standards compliance Quality data, clean and fast Early and real-time access to clean data Faster database lock Predictable pricing Global Help Desk assistance 24/7 5

6 Predictable Pricing Clinical Data Management Real-time Data Access Full Service EDC Phase I-IV

7 A world of expertise. Our expert data management services are designed to make every part of the process more efficient and more predictable. Our clinical data managers know how to make EDC technology work for you to ensure the best possible results. We minimize the risks associated with EDC and clinical research data management, and help you capture clean and accurate clinical research data, while meeting key deadlines and budget requirements. So you ll spend less time training for each project and more time running efficient trials. Although our clinical data specialists manage all the data, you stay in complete control with continuous access to your data and total transparency to the study progress. Full Service EDC a unique approach delivers better results. Unlike any other service provider, BioClinica is the one partner to provide Full Service EDC. Combining our expert data management services with In addition to data management, we can help you get cleaner data, faster, with a variety of support services: Upfront consultation and design EDC process overview and consultation Study start-up Initiation Data collection Coding Quality control Standards support Submission our best-of-breed EDC technology, Full Service EDC enables sponsors to outsource all data management responsibilities to a single technologyenhanced service organization. Our solution helps you conduct trials more efficiently and delivers the clean data you need for faster database lock, reports and submissions. So you can enjoy the benefits of traditional EDC without having to battle a learning curve or manage resource overload all at a price point that reflects our efficiency. 7

8 Full Service EDC Phase I-IV Clinical Data Management Sophisticated Edit Checks Predictable Pricing Forms Library Real-time Data Access A world of flexibility.

9 As the volume and complexity of data increase, electronic data capture is essential. You need an EDC solution that s flexible, simple and delivers results in real time. That s why BioClinica provides a complete suite of customized solutions based on the unique needs of your trial. Supported by our industry-leading technology, all of our solutions adapt to your study and integrate seamlessly with your existing technology, with no need for added resources or IT investment. BioClinica s suite of proven solutions. BioClinica Express The leading choice for challenging connectivity situations, this comprehensive EDC solution adds speed and quality to every part of the clinical trial process. BioClinica Express provides time-tested, stable technology that acts as a central hub to coordinate and organize the collection and dissemination of clean data under any conditions. BioClinica IVR /IWR Our IVR solution is the first to fully leverage IVR as a completely integrated clinical component for your clinical trial. We also offer an Interactive Web Response (IWR) system that speeds data capture, while saving significant time and money. These two solutions are components of the same system, and not simply interfaced with the EDC system. This reduces cycle time for study initiation with rapid configuration and deployment. BioClinica Reportal This solution provides access to all critical study reports and clinical intelligence through a centralized knowledge management portal. With BioClinica Reportal, you get clean, accurate data and real-time visibility with no need for expensive supplementary software or additional training and support. 9

10 A world of simplicity. To get the most out of EDC, you need more than just best-of-breed technology. You also need a partner who offers reliable data management and flexible support services. BioClinica offers a totally inclusive menu of services to support you throughout the duration of your trial. Rather than a highly componentized, à-la-carte pricing plan, we include all the services to build, deploy and run your trial, from tailored training programs to 24-hour IT assistance. And we never charge for a change order.

11 Clinical Data Management Predictable Pricing Phase I-IV Real-time Data Access Full Service EDC Sophisticated Edit Checks Forms Library Our comprehensive service offerings include: 24/7 Help Desk Even if you don t have in-house EDC expertise or IT support, we can provide responsive assistance for all of our products, from deployment to study close out. Our support teams are experts in BioClinica technology and networking, and can quickly resolve site and sponsor issues whenever they arise. We can even handle requests in 150 languages. Training From login, to data entry and review, to system navigation, our comprehensive training programs help your site personnel and team members avoid common issues during every phase of the trial. We offer a variety of options, including instructor-led meetings, site visit training or customized pre-trial programs. We can even provide pre-recorded, online training via WebEx, giving you the ability to re-familiarize yourself mid-trial, if necessary. Coding The BioClinica AutoEncoder virtually eliminates the need for manual coding or additional systems by automating your entire coding process. Our streamlined coding solution delivers greater accuracy and also ensures FDA compliance. As a standard component of all BioClinica EDC services, the AutoEncoder standardizes coding and medical terminology, centralizes data across large studies and supports both standard and custom medical dictionaries. Trusted compliance support. BioClinica also provides in-depth services to help understand the business benefits of using CDISC. These standards can accelerate the regulatory review process, using a forms library that is constructed to deliver electronic clinical trial data to the FDA in the CDISC SDTM format. We can get you started on strategic initiatives, putting our knowledge of CDISC and specifically CDASH to work designing EDC forms that help you format data in conformance with these standards. 11

12 United States 826 Newtown-Yardley Road Newtown, PA East 8th Avenue, Suite 201 King of Prussia, PA Europe Schipholweg XC Leiden The Netherlands Avenue Rockefeller F Lyon, France Bio-Imaging Technologies and Phoenix Data Systems have joined forces to become BioClinica.