BIOCLINICA, INC. TO DEMONSTRATE TECHNOLOGY-ENHANCED CAPABILITIES AT UPCOMING GLOBAL INDUSTRY EVENTS

Transcription

1 Company Contact - Jim Dorsey BioClinica, Inc Trade Media Morgan Dub Karpo Diccicco Battista Communications FOR IMMEDIATE RELEASE BIOCLINICA, INC. TO DEMONSTRATE TECHNOLOGY-ENHANCED CAPABILITIES AT UPCOMING GLOBAL INDUSTRY EVENTS NEWTOWN, PA, April 2, 2013 BioClinica, Inc. a global provider of clinical trial management solutions, today announced that members of its team will attend, participate in, and speak at several upcoming industry conferences in April, May, and June. BioClinica experts will discuss industry trends and demonstrate the company s suite of technologies and solutions. The conferences include: CLUB PHASE 1 Joint Conference of European Human Pharmacological Societies April 11 12, 2013 Nice, France CLUB PHASE I is a French association created in 1993 whose members are individuals involved in the early clinical development stage of medical research and come from a variety of professional areas including the pharmaceutical industry, clinical research organizations, and university hospitals. This year s meeting will bring together European colleagues of Association for Applied Human Pharmacology (AGAH), Association of Phase- 1 Units, Belgique (BAPU), and the British Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI). The meeting will focus on early clinical utility assessment of new medicines and how early development should be conducted to optimize the challenging process of reaching efficient and early go/no go decisions. Dr. Boaz Mendzelvski, now BioClinica s Vice President of Cardiology following the March 2013 merger with CoreLab Partners, will speak on the topic Cardiac Safety, QT Assessment. DIA 7 th Annual Conference in Japan for Asian New Drug Development April 15 16, 2013 Tokyo, Japan Booth # 2 The 7th DIA Asia New Drug Development Conference will provide a forum for the exchange of opinions among East Asian regulatory agencies about how multiregional clinical trial (MRCT) data should be utilized and reviewed in new drug applications. MRCTs in East Asia, including Japan, China, Korea, and Taiwan, are now considered one of the promising key strategic options in new drug development. As understanding has deepened through experience with these trials, it is important that industry, governments, and academia come together to discuss and resolve outstanding issues and make improvements in collaboration internationally to activate new drug development in Asia. The conference will include constructive discussions, keynote speeches, and interactive workshops on this important topic. BioClinica representatives will be on hand to demonstrate the company s Imaging Core Lab and Cardiac Safety monitoring services. - more-

2 -2- Partnerships in Clinical Trials April 21 24, 2013 Orlando, Florida Booth #513 Billed as the world s most authentic gathering on collaborating for clinical trial excellence, Partnerships in Clinical Trials is the premiere meeting for senior level decision makers across the globe. This year's agenda guarantees to equip attendees with strategies to innovate the clinical trial landscape, a platform to establish essential relationships, and the means to push business forward. The conference will feature three tracks: patient-centered clinical trials, partnering for success in virtual research and development, and cost and contract management. It will also include a strategy summit for small to midsized pharmaceutical and biotechnology companies. BioClinica representatives will attend the conference to demonstrate the company s industry-leading eclinical solutions and Imaging Core Lab and Cardiac Safety services. Global Clinical Supplies Group April 21 24, 2013 Santa Anna Pueblo, New Mexico The GCSG conference is the most comprehensive conference in the clinical supply chain arena, offering an open forum for sharing knowledge and best practices for clinical supply and related professionals. BioClinica representatives will be on hand to demonstrate the company s suite of clinical trial services that maximize efficiency and manageability of the clinical trial process. Nick Lenares, Chief Product Architect, will demonstrate BioClinica s Clinical Supply Optimizer solution during workshop six on April 23 at 2:00 pm. ShareFEST 2013 April 25, 2013 Booth #16 ShareFEST is the premier SharePoint conference for life sciences, attended by senior business and IT professionals from over 120 pharmaceutical companies, device manufacturers, biotechs, and service providers. This year s conference will focus on the topic Compliance Strategies for the Global Enterprise with sessions on building global compliance solutions, scaling to address enterprise needs, and managing and leveraging SharePoint technology. Representatives from BioClinica will attend the conference and will be on hand to demonstrate OnPoint, our Microsoft Office-Smart Clinical Trial Management System. Using BioClinica s OnPoint CTMS as a demonstration platform, eclinical Solutions Specialist and CTMS expert Jeremiah Rehm will present on the topic of CTMS and etmf integration Drug Information Association (DIA) China Annual Meeting May 12, 2013 Beijing, China Booth #B2 The 5th DIA China Annual Meeting is the largest meeting held by DIA in the Asia and Pacific region. The meeting provides a neutral platform for information exchange and features speakers that include high-level representatives from the pharmaceutical industry, government, and academia in China and abroad. With an expected attendance of over 1200 professional participants, DIA China will feature plenary and parallel sessions, including pre-conference workshops, forums, speakers and presentations, panel discussions, a call for abstracts and posters, exhibitions, networking receptions, and more. This year's theme, "Patient Safety: A Sustained Focus from Scientific Ideas to Innovative Medicines," will reinforce patient safety as a core element of therapeutic innovation and a key philosophy throughout the life cycle of biopharmaceutical research and development. BioClinica representatives will be on hand to demonstrate the company s Imaging Core Lab and Cardiac Safety services. BioClinica User Conference

3 -3- May 14 15, 2013 The 2013 BioClinica User Conference is two days filled with insider information to help customers get the most out of BioClinica s eclinical Solutions and run faster, more efficient trials. BioClinica s four eclinical Solutions, OnPoint CTMS, Express EDC, Trident IWR/IVR, and Optimizer, will be featured in focused tracks filled with informative presentations, case studies, success stories, and panel discussion. This is a free event conducted exclusively for BioClinica customers. BioClinica Oncology Symposium May 14, 2013 The BioClinica Oncology Symposium is a complimentary event that brings together leading minds to discuss the role of medical imaging in oncology clinical trials. The symposium will include presentations on subjects such as PET in oncology and incidental findings, discussions on the role of cardiovascular safety monitoring, and a debate over the efficiencies of central verses local review of medical images. Dr. Larry Schwartz of Columbia University will present the keynote address Imaging Biomarkers Oncology as a Paradigm. Outsourcing in Clinical Trials Europe May 14 15, 2013 Zurich, Switzerland Booth #10 Outsourcing in Clinical Trials bring major pharmaceutical and biotech manufacturers together to debate potential solutions to the complex challenges of running global clinical trials. The agenda for this year s event includes presentations covering partner selection, relationship management, regulatory developments, and outsourcing models. The event will also include presentations from a financial investor as well as a communications expert bringing outside expertise that will help revolutionize business and management strategies. BioClinica representatives will attend the conference to demonstrate the company s industry-leading eclinical solutions and Imaging Core Lab and Cardiac Safety services. Global Clinical Trials Outsourcing Summit May 20 22, 2013 Seoul, Korea The 2nd Global Clinical Trials Outsourcing Summit will provide a forum for discussion and networking between Western and Eastern pharma, biotech and CRO senior level executives to discuss the current landscape, future developments and opportunities of clinical trials in Asia by addressing unique operational, CRO management, outsourcing, regulatory, data management, pharmacovigilance/safety and clinical supply and logistical qualities and challenges associated with countries in the region. Dr. Boaz Mendzelvski, now BioClinica s Vice President of Cardiology following the March 2013 merger with CoreLab Partners, will speak on the topic Cardiac Safety Trends in Asian Clinical Trials. Society for Clinical Data Management (SCDM) Asia Conference May 31 June 1, 2013 Mumbai, India SCDM is proud to announce its first conference outside the US. The theme of the conference is The Changing Landscape of CDM: Transformational Trends and Technological Innovations. The deliberations during the conference will be based on trends and technological innovation in the CDM segment. The conference is a comprehensive, multi-disciplinary event, where leading national and international experts will provide thought leadership. It will feature two tracks and pre-conference workshops focusing on Evolving Trends in Data Management, Standards and Transformational Initiatives impacting CDM, Outsourcing Strategies in CDM, The growth of CDM in Asia - Mapping the landscape, East meets West - Working across geographies, and the Evolution of CDM - Global Vision 2020.

4 -4- Jonathan Andrus, Senior Vice President of Operations for BioClinica, will chair a session and speak on the topic Evolving Trends in Data Management and Industry-wide Transformational Initiatives. Additionally, he will participate in the conference s leadership forum. American Society of Clinical Oncology (ASCO) Annual Meeting May 31 June 4, 2013 Chicago, Illinois Booth # Bringing together more than 25,000 oncology professionals from a broad range of specialties, the 2013 ASCO Annual Meeting will feature cutting-edge scientific presentations and comprehensive educational content. More than 5,000 abstracts are accepted each year, showcasing the latest breakthroughs in the progress against cancer with important and sometimes immediate implications for patient care and practice. Members of BioClinica s Medical Affairs group will attend the conference. Second Annual Vendor Management in Clinical Trials Conference June 3 4, 2013 Boston, Massachusetts Strategies and tools for assessing, implementing and improving quality when partnering with clinical service providers will be the focus of the second annual Vendor Management in Clinical Trials conference, part of the Clinical Trial Oversight Summit. With growing regulatory expectations for a quality systems-based approach to good clinical practice (GCP) compliance, sponsors must be certain that their third party vendor partners are inspection ready. Thought leaders will present their compliance-focused vendor management strategies, from selection through contracting and oversight. With domestic and international regulatory inspection trends in mind, speakers will guide attendees in implementing their own vendor qualification and management strategies. Risk-based approaches to vendor management will be addressed, as well as auditing of clinical service providers. Attendees can expect case studies, take-away tools, perspectives on the current regulatory environment, breakout groups and interactive activities. Jonathan Andrus, Senior Vice President of Operations for BioClinica, will speak on the topic Partnering for Clinical Trial Success. Rebecca Cope, Product Manager for BioClinica, will speak on the topic Leveraging the Sponsor-CRO Relationship for Study Success. Public CDISC Courses Hosted by BioClinica June 4 7, 2013 Audubon, Pennsylvania As part of the company s commitment to promoting quality data standards across the industry, BioClinica is pleased to host three public CDISC training courses at our eclinical headquarters at 800 Adams Avenue in Audubon, Pennsylvania. CDISC has developed specialized education programs with the cooperation of the technical teams that developed each standard. The goals of these programs are to provide authoritative education in the theory and practice of using the CDISC standards, and to provide the tools and information needed to implement the standards within an organization. This training is geared toward anyone working with data in medical research including statisticians, clinical programmers, and clinical data managers. Attendees will learn how the CDISC standards can be implemented in their daily work. June 4 5, 2013: 2-day SDTM Theory and Application June 6, 2013: 1-day CDASH Implementation June 7, 2013: 1-day ADaM Implementation

5 -5-2nd Annual ClinTech Congress June 11 12, 2013 Dublin, Ireland The ClinTech Congress will focus on ways the pharmaceutical industry can streamline the clinical trial process through effective system management. The industry has demonstrated success leveraging clinical technology to increase effectiveness in managing clinical study information coming from a variety of sources. This conference provides in-depth knowledge on etmf, IVR/IWR, CTMS and Portal systems, as well as building blocks for system integration. Attendees will learn how to effectively deploy an etmf and ensure quality of documents, leverage a CTMS to streamline clinical trial processes, and examine how a portal improves oversight of study/site management. BioClinica is a sponsor of this event and will have representatives on hand to demonstrate the company s industry-leading eclinical solutions. Jonathan Andrus, Vice President of Operations for BioClinica, will speak on the topic Ensure Due Diligence During System and Vendor Selection. Drug Information Association 49 th Annual Meeting June 23 27, 2012 Boston, Massachusetts Booth #1210 The DIA annual meeting is the pharmaceutical industry s premier event. More than 7,500 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products will come together to foster innovation and facilitate health and well-being worldwide. BioClinica will have representatives on hand to demonstrate its innovative eclinical solutions and leading Imaging Core Lab and Cardiac Safety services. Jeffrey Heilbraun, MS, BioClinica s Director of Strategic Development following the March 2013 merger with CoreLab Partners, will present on the topic Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations on June 27 th at 10:45AM as part of the Clinical Safety and Pharmacovigilance track. About BioClinica, Inc. BioClinica, Inc. is a leading global provider of integrated, technology-enhanced clinical trial management services. A 2013 merger with CoreLab Partners has created a new standard in imaging core lab services including electronic transfer, management, and independent review; cardiovascular safety monitoring including automated ECG, Thorough QT studies, Holter monitoring, ambulatory blood pressure monitoring and pulse wave analysis; and eclinical solutions for electronic data capture, randomization, clinical trial management, and clinical supply chain forecasting and optimization. BioClinica offers unmatched scientific expertise with a team of respected medical researchers and board certified, sub-specialty trained radiologists, cardiologists, nuclear medicine physicians and oncologists. With more than 28 years of experience and over 3300 successful trials to date, BioClinica has supported the development of many new medicines through all phases of the clinical trial process. BioClinica operates state-of-the-art, regulatory-body-compliant imaging core labs on two continents, and supports worldwide comprehensive cardiovascular safety, and eclinical and data management services from offices in the United States, Europe and Asia. For more information, please visit #####