Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS

Transcription

1 Global clinical trial solutions. Real-world results. Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS Clinical Trial Management Clinical Data Management

2 A world of solutions. Discover the power of BioClinica. BioClinica is the proven, optimal choice for your next clinical trial. We provide comprehensive clinical trial solutions and management for pharmaceutical, biotechnology and medical device companies. Our Imaging and eclinical divisions are trusted by today s top pharmaceutical companies thanks to our passion, expertise and innovative products and processes. We have supported over 2000 studies in all phases of clinical trial development and in a broad range of therapeutic areas including Oncology, Cardiology, Metabolism, Inflammation, Endocrinology and Neurology, and more. With thousands of successful clinical trials, our team of experts knows how 2

3 BioClinica believes in running more efficient, cost-effective trials and providing customer service that goes above and beyond client expectations. Our success is based on: A shared set of values and a commitment to excellence Researching innovative technologies to improve our products Constantly evolving and adapting to improve internal processes Building strong and trusting relationships with our clients to bring your drug or device to market in the most efficient way possible.

4 BioClinica has experience conducting thousands of eclinical studies and processing and assessing millions of images. A world of expertise. The processes and technology incorporated into our offerings are designed to provide clients with the ease of use and scalability to handle large global trials as well as the flexibility, speed and efficiency necessary to support smaller or early phase trials. Rely on BioClinica s extensive knowledge to support your trial at every stage: Upfront consultation and design Study start-up Data collection Coding Quality control Standards support Data Management Data Export Submission 4

5 Rely on our network of experts and strong history to support your trial. Our specialists can supplement your staff and can help reduce training for each project, thereby improving timelines. Our strong roster of collaborative consultants, which includes board-certified radiologists, oncologists, rheumatologists, cardiologists and other therapeutic specialists, provide targeted expertise and quality results. Our expertise has helped us successfully complete numerous client and FDA audits. Based on the large number of FDA submissions, we have participated in numerous not-for-cause, study-specific audits resulting in no 483s or other findings.

6 Imaging Core Lab Solutions Our state-of-the-art, FDA-compliant imaging core labs offer world-class services including: study initiation and start-up, collection, management and processing of medical image data, and independent blinded reads. Our vast roster of collaborative consultants includes board-certified therapeutic specialists to ensure the highest quality independent reviews. BioClinica s BioPACS is a custom designed enterprise system that provides image workflow, query, inventory, site and project management tools to automate and accelerate the process of evaluating images generated during a clinical trial. BioREAD consists of hardware and software that are used to perform independent blinded reads on the image data collected during the clinical trial. BioClinica WebSend solution improves clinical trial efficiency through the electronic transfer of images via the Internet providing faster delivery, fewer site queries, and reduced costs versus standard shipping. BioClinica WebSend BioClinica Express Electronic Data Capture BioClinica Express, our comprehensive EDC solution, adds speed and quality to every part of the clinical trial process. It provides flexible, scalable technology that acts as a central hub to coordinate and organize the collection and dissemination of clean data under any conditions. Our Electronic Data Capture Solution makes it easier to monitor protocol compliance, close studies faster all while meeting necessary regulations and guidelines. Our EDC technology integrates easily with your other clinical processes and technology applications. We 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 of your trial. A world of technology. 2,000 Clinical Trials. International Clinical Trials. 11,000+ Site Managed. 80+Countries. Global. 27/4 Support. Site Training. Data Collection. Data Management. IVR Electronic Data Capture. Certified Radioloogist. Image Quality Control. Angiography. EDC Integration. Clinical Data Management. FDA-compliant. Medical Image Managem Verification. Protocol Design. Image Identification. Data Management. Image De-identification. CDISC. CDASH. Pivotal Trials. CNS. Expert Readers. Integrated Lab Data Capabilities. Adaptive Trials. Real-time Data Access. IVR. Parameter Driven IWR. Pluggable Custom Code. Custom Data. Highly Scalable. Clinical Trial Supply Forecastin Global. Independent Blind Read. State-of-the-art. Global Capabilities. DXA. CT. Safety. Next-generation Interactive Web Response System. Ultrasound. X-ray. BioClinic 2,000 Clinical Trials. International Clinical Trials. 11,000+ Site Managed. 80+Countries. Global. 27/4 Support. Site Training. Data Collection. Data Management. IVR Data Capture. Certified Radioloogist. Image Quality Control. Angiography. Phase I-IV. Clinical Data Management. FDA-compliant. Medical Image Management. Certified tion 6 Protocol Design. Image Identification. Clinical Data Management. Image De-identification. CDISC. CDASH. Pivotal Trials. CNS. Expert Readers. Integrated Lab D. Next-generation Interactive Web Response System. Ultrasound. X-ray. BioClinica Express. BioClinica Optimizer. BioClinica WebView. BioClinica WebSend. BioClinica

7 Clinical Trial Supply Planning BioClinica Optimizer is the world s leading clinical trial supply forecasting tool. The Optimizer allows you to design unlimited clinical trial supply chain scenarios and vary relevant study parameters from a global level down to a site level. The simulated results can be analyzed and modified to create the ideal clinical supply plan. This accurate forecasting of the supply helps you reduce risks and manage costs allowing you to accurately plan even the most complex trials and helps you get the right quantities to the right places in the world at the right time. BioClinica Optimizer easily allows you to upload the actual data from your IWR/IVRS to use for study observation, comparison against assumptions, and further simulation and tuning of the running protocol. BioClinica Optimizer BioClinica Trident IWR IWR/IVRS BioClinica Trident, our interactive web response system (IWR), has an intuitive user interface that empowers business users (not programmers!) to quickly set up, test and deploy new protocols, and then monitor and maintain them in one easy place. This eliminates the costly and slow routine of writing development specifications, programming and validating a new IWR system each time a new study comes along. All the actions performed on the web are simultaneously available on the phone via Trident s interactive voice response system (IVRS). Trident s IWR single database for all clinical studies allows automatic drug pooling support, serving as a single source for reporting and standard data organization for clinical trials. BioClinica s products are all flexible and highly R Quality Control. Best-of-breed. Cardiology. Musculoskeletal. Osteoporosis. Osteoarthritis. Rheumatoid Arthritis. Oncology. Neurology. Efficacy. Diagnostic Agents. Clin ent. CTMS Solutions. Innovative Technologies. Parameter Driven IWR. Global Delivery. Over 5 Million Images Processed. eclinical Technology Suite. 21 CFR Part 11 Complia. CRO Partnerships. Predictable Pricing. Electronic Trial Expertise. Radiology. Film. Electronic Image Transmission. Drug Supply Chain. Patient Diaries. epro. Patient Repo g. Monte Carlo Statistical Simulations. Advanced Reporting. Pooled Drug Supply Across Protocols. Variable Dosing. 360 o Integration. Industry-leading. Help Desk. Interactive a Express. BioClinica Optimizer. BioClinica WebView. BioClinica WebSend. BioClinica Trident. Efficacy. Global Clinical Trial Solutions. Real-world Results. Imaging Core La Quality Control. Best-of-breed. Cardiology. Musculoskeletal. Osteoporosis. Osteoarthritis. Rheumatoid Arthritis. Oncology. Neurology. Efficacy. Diagnostic Agents. Clinic d Radiologists. Innovative Technologies. Parameter Driven IWR. Global Delivery. Over 5 Million Images Processed. eclinical Technology Suite. 21 CFR Part 11 Compliant. I ata. CRO Partnerships. Predictable Pricing. Electronic Trial Expertise. Radiology. Film. Electronic Image Transmission. Drug Supply Chain. Full Service EDC. Clinical Tria Trident. Efficacy. Global Clinical Trial Solutions. Real-world Results. Imaging Core Lab Services. eclinical Services. Clinical Trial Supply Simulation. Imaging Endpoints.

8 Clinical Trial Management BioClinica OnPoint is a fully-featured Clinical Trial Management System (CTMS) that helps life sciences companies manage their clinical trials within schedule and budget. Today s study professionals face new complexities in a web-enabled world of distributed work teams and clinical trial applications that don t talk to each other. OnPoint offers advanced integration technologies that consolidate operational data from clinical trial applications like EDC, IWRS and Safety systems to present one clear picture for study managers. And, Microsoft SharePoint, coupled with BioClinica s unique Office-Smart technology, can open up a new world of role-based portals and interoperability with familiar Microsoft Office desktop applications. BioClinica OnPoint Clinical Data Management Clinical Data Management Our expert data management services make every part of the clinical data management process more efficient and predictable. Our clinical data managers minimize the risks associated with EDC and clinical data management and help you capture clean and accurate clinical research data, while meeting key deadlines and budget requirements. You ll spend less time training for each project and more time running efficient trials. Although our clinical data personnel manage all the data, you stay in complete control, with continuous access to your data and the progress of the study. customizable to meet your specific study needs. ical Trial Forecasting. Simulation. Buffer Stock Optimization. Clinical Trial Management. Imaging Core Lab. Therapeutic Expertise. Data Collection Expertise nt. Integrated Data Management. Clinical Trial Data Analysis. Electronic Case Report Forms. Forms Library. Clinical Study Documents. Sophisticated Edit Checks rted Outcomes. Biomarkers. IVR/IWR. Parameter Driven IWR. EDC Integration. Diagnostic Agents. Faster Database Lock. FDA-compliant. RECIST. Cheson. Global e Voice Response System. Interactive Web Response System. Full Service EDC. Clinical Trial Management System. CTMS. Bio-READ. Bio-TRACK. Bio-PACS. Bio-DXA b Services. eclinical Services. Clinical Trial Supply Simulation. Imaging Endpoints. EDC Integration. FDA-Compliant. MRI. Nuclear Medicine. PET. Imaging Endpoints al Trial Forecasting. Simulation. Buffer Stock Optimization. Clinical Trial Management. Imaging Core Lab. Therapeutic Expertise. Data Collection Expertise. Electronic Integrated Data Management. Clinical Trial Data Analysis. Electronic Case Report Forms. Forms Library. Clinical Study Documents. Sophisticated Edit Checks. Verifical Management System. CTMS. Bio-READ. Bio-TRACK. Bio-PACS. Bio-DXA. Global. Independent Blind Read. State-of-the-art. Global Capabilities. DXA. CT. Safety 360 o Integration. Industry-leading. Help Desk. Interactive Voice Response System. Next-generation Interactive Web Response System. RECIST. Cheson. CTMS. Full

9 A world of technology. With over 20 years of industry experience, we offer a full range of eclinical and Imaging Core Lab solutions. You can trust BioClinica to manage technology on your behalf and provide deep clinical expertise. As a full service eclinical provider, BioClinica offers EDC, Data Management, CTMS solutions, forecasting, simulation/optimization and IVR/IWR technologies. Our independent Imaging Core Lab (ICL) offers medical image management solutions that cover the full range of imaging modalities which span the entire life cycle of your trial. Together, these solutions make BioClinica a leading expert in clinical trials. With thousands of successful clinical trials completed, our experienced employees and experts know how to efficiently bring your drug or device to market. BioClinica has over 20 years of clinical trial process knowledge including 2000 projects worldwide for over 200 clients, 11,000 sites in 88 countries (North America, South America, Western Europe, Eastern Europe, Australia, China, India) Our management team has over 120 years of experience combined We have subject matter experts, scientists and doctors on staff Our products and services are designed to help our clients operate in a manner that is compliant with applicable regulations and follows relevant regulatory guidance 2,000 Clinical Trials. International Clinical Trials. 11,000+ Site Managed. 80+Countries. Global. 27/4 Support. Site Training. Data Collection. Data Management. IVR Quality Control. Best-of-breed. Cardiology. Musculoskeletal. Osteoporosis. Osteoarthritis. Rheumatoid Arthritis. Oncology. Neurology. Efficacy. Diagnostic Agents. Clinical Trial Forecasting. Simulation. Buffer Stock Optimization. Clinical Trial Management. Imaging Core Lab. Therapeutic Expertise. Data Collection Expertise. Electronic Data Capture Imaging. Certified Radioloogist Core. Image Lab. Quality eclinical Control. Angiography Solutions.. Phase I-IV. Clinical Data Integrated Management. FDA-compliant Support.. Medical Image Management. CTMS Solutions. Innovative Technologies. Parameter Driven IWR. Global Delivery. Over 5 Million Images Processed. eclinical Technology Suite. 21 CFR Part 11 Compliant. Integrated Data Management. Clinical Trial Data Analysis. Electronic Case Report Forms. Forms Library. Clinical Study Documents. Sophisticated Edit Checks. Verification. Protocol Design. Image Identification. Data Management. Image De-identification. CDISC. CDASH. Pivotal Trials. CNS. Expert Readers. Integrated Lab Data. CRO A value no other clinical trial service provider can match. Partnerships. Predictable Pricing. Electronic Trial Expertise. Radiology. Film. Electronic Image Transmission. Drug Supply Chain. Patient Diaries. epro. Patient Reported Outcomes. Biomarkers. IVR/IWR. Parameter Driven IWR. EDC Integration. Diagnostic Agents. Faster Database Lock. FDA-compliant. RECIST. Cheson. Global Capabilities

10 Our Quality Control process helps you increase efficiencies, prevent back-end delays and decrease the number of queries in your clinical trial. A world of quality. Whether you need a solution to help manage your medical imaging data, or you want to take advantage of BioClinica s combined imaging and eclinical offerings, we provide a level of quality and precision that you can trust. You can see our commitment to quality in everything we do. For us, excellence isn t optional. It s our goal, every time, with every trial. It s why we developed a rigorous multi-step process for our medical image review and why we take a different approach to eclinical technology and help manage it on your behalf. The result? Data that is not just clean and accurate, but also accessible, analyzable and actionable. This unique business model, which provides cost control and transparency, not only in the budgeting process, but also throughout the trial duration, puts fiscal control back in the sponsors hands, where it belongs. 10

11 Our time-tested processes enhance the quality of your trial. Quality, efficiency, and accuracy is how we deliver: 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 price Global Help Desk assistance 24/7

12 A world of service. To get the most out of your clinical trial, you need a proven partner who can provide reliable and flexible support. At BioClinica, we believe in making things simple for our customers. We offer an inclusive menu of services to support you with the planning and execution throughout the duration of your trial. Our comprehensive service offerings include: 24/7 Help Desk BioClinica has created a scalable, well-defined global support process to ensure site and sponsor issues are quickly and completely resolved. The BioClinica Support Services Department provides multi-lingual technical support to sponsors and users worldwide 24 hours a day, 7 days a week. Support requests are supported in over 150 languages by on-site employees and, when needed, an interpreter assistance service. Unlike other companies that outsource their help desk, our support teams are experts in BioClinica technology and networking, which is why we can quickly resolve site and sponsor issues whenever they arise. Training Our comprehensive training programs teach site, sponsor and team personnel to easily navigate our products as well as avoid common issues during every phase of the trial. We offer a variety of options including: Instructor-led meetings, i.e. hands-on training at investigator meetings Site-visit training Customized pre-trial programs Pre-recorded or live online training via WebEx Certifications for regulatory binders CDISC Implementation BioClinica is able to create CDISC CDASH conformant case report forms for your study which yields the most direct path to complete CDISC SDTM submission datasets. This reduces review time, aids in the approval of CRFs, minimizes data queries and improves data integration. Whether you need help developing CDASH forms or providing SDTM datasets, BioClinica can help and train your company to understand and meet all CDISC standards. To get the most out of your clinical trial, you need a proven partner who can provide reliable and flexible support... 12

13 BioClinica provides in-depth CDISC services to help you accelerate the regulatory review process.

14 Global clinical trial solutions. Real-world results. United States BioClinica - HEADQUARTERS 826 Newtown-Yardley Road Newtown, PA BioClinica 800 Adams Avenue Audubon, PA EUROPE BioClinica, B.V. Schipholweg XC Leiden The Netherlands BioClinica, S.A.S. Adenine Bioparc 60 Avenue Rockefeller F Lyon, France ,000 Clinical Trials. International Clinical Trials. 11,000+ Site Managed. 80+Countries. Global. 27/4 Support. Site Training. Data Collection. Data Management IVR Quality Control. Best-of-breed. Cardiology. Musculoskeletal. Osteoporosis. Osteoarthritis. Rheumatoid Arthritis. Oncology. Neurology. Efficacy Diagnostic Agents. Clinical Trial Forecasting. Simulation. EDC Integration. Clinical Trial Management. Imaging Core Lab. Therapeutic Expertise. Data Collection Expertise. Electronic Data Capture. Certified Radioloogist. Image Quality Control. Angiography. State-of-the-art. Clinical Data Management. FDA-compliant Medical Image Management. CTMS Solutions. Innovative Technologies. Parameter Driven IWR. Global Delivery. Over 5 Million Images Processed. eclinical Technology Suite 21 CFR Part 11 Compliant. Integrated Data Management. Clinical Trial Data Analysis. Electronic Case Report Forms. Forms Library. Clinical Study Documents Sophisticated Edit Checks. Adaptive Trials. Protocol Design. Image Identification. Data Management. Image De-identification. CDISC. CDASH Pivotal Trials. CNS Expert Readers. Integrated Lab Data. CRO Partnerships. Therapeutic Expertise. Electronic Trial Expertise. Radiology. Film. Electronic Image Transmission Drug Supply Chain. Patient Diaries. epro. Patient Reported Outcomes. Biomarkers. IVR/IWR. Parameter Driven IWR. EDC Integration. Diagnostic Agents Faster Database Lock. FDA-compliant. RECIST. Cheson. Global Capabilities. Verification. Real-time Data Access. IVR. Parameter Driven IWR Pluggable Custom Code. Custom Data. Highly Scalable. Clinical Trial Supply Forecasting. Monte Carlo Statistical Simulations. Advanced Reporting. Pooled Drug Supply Across Protocols. Variable Dosing. 360 o Integration. Industry-leading. Help Desk. Interactive Voice Response System. Interactive Web Response System Full Service EDC Clinical Trial Management System. CTMS. Bio-READ. Bio-TRACK. Bio-PACS. Bio-DXA. Global. Independent Blind Read. Phase I-IV. Global Capabilities DXA. CT. Safety. Next-generation Interactive Web Response System. Ultrasound. X-ray. BioClinica Express. BioClinica Optimizer. BioClinica WebView BioClinica WebSend. Full Service EDC. Efficacy. Global Clinical Trial Solutions. Real-world Results. Imaging Core Lab Services. eclinical Services. Clinical Trial Supply Simulation. Imaging Endpoints. EDC Integration. FDA-Compliant. MRI. Nuclear Medicine. PET. Imaging Endpoints. 2,000 Clinical Trials