Accelovance 2275 Research Boulevard, Suite 700 Rockville, MD 20850, United States Phone: +1.240.238.4900 Fax: +1.240.238.4901 Internet: www.accelovance.com email: gsmith@accelovance.com Contact Person: Garrett Smith A PROVEN APPROACH to ACCELERATED CLINICAL DEVELOPMENT Control Over Operations > Enhanced Productivity > Cost & Time Savings = RESULTS! FLEXIBLE SERVICE OFFERING TAILORED TO MEET YOUR NEEDS - Full CRO Services - Wholly Owned Research Dedicated Clinical Sites - Patient Management : Recruitment, Retention, Compliance - CLINICAL Call Center - Late Stage /Safety Service Recognized as 2009 s BEST CRO with a Vaccine Industry Excellence (ViE) award, Accelovance s innovative approaches have driven clinical productivity and performance within the niche market of Vaccines but also address quality, cost-savings, speed and partnering needs of other therapeutic areas. We uniquely combine our ownership of six (6) clinical research sites and internal patient management (not just recruitment, but retention and compliance also) solutions to create operational efficiencies that enhance quality, site and study productivity, and the timely delivery of research programs. We engage with Sponsors directly or through another CRO we are flexible to any working arrangement. Let s evaluate the impact we can make on your next clinical study. Let our results serve as examples of the tangible value Accelovance can bring to a Sponsor: 25-75% reduction in study/enrollment timelines 20-25% cost-savings vs. standard industry pricing Accurate Pricing = no CRO generated change orders Partnership and Commitment = communication and shared success CRO Services: flexible to meet your needs. Project Management, Regulatory Affairs, Quality Assurance, Medical Monitoring, Clinical Monitoring, Data Management, BioStatistics, Safety and Late Stage Services. Accelovance serves as an extension of your team offering these services as needed and flexible to work with other preferred vendors. Our ownership of sites gives the CRO team the additional patient and operational perspective necessary to effectively manage the study. Clinical Sites: wholly owned and research dedicated. Our six (6) clinics average 3,000 SF in size and are staffed with full time Accelovance employees. Quality is emphasized through centralized SOPs and corporate training programs. Each clinic is positioned for highly coordinated and/or high volume enrollment; offering the Sponsor predictability and performance assurances. Patient Management: more than recruitment and retention. Accelovance proactively recruits patients through its own databases, media and community outreach. Our innovative approaches pre-qualify patients prior to study start to find the right patient for the study. This planning allows for predictable, controlled and timely enrollment along with higher retention and compliance rates. Clinical Call Center: surveillance, retention, compliance. Let clinically trained agents help manage your patients through their study visit schedule and beyond. Accelovance has managed programs with 400 patients to 19,000 patients in a costeffective manner by pairing experienced agents who understand clinical research with robust technology that maximize efficiencies and reporting. Should a sponsor wish to explore an opportunity in China s rapidly growing pharmaceutical market, Accelovance China has offices in Shanghai and Beijing, PR China providing small pharma/biotech and multinational pharma companies with CRO and market registration services. Services: Clinical R&D, Data Management, Inpatient/Outpatient Facilities, Patient Compliance, Patient Recruitment, Pharmacovigilance, Project Management, Rx to OTC Switch, Trial Management, Vaccine Development visit www.diahome.org to view our most current, searchable, online directory 1
Algorithme Pharma 575 Armand-Frappier Boulevard Laval, QC H7V 4B3, Canada Phone: +1.450.973.6077 Phone: +1.450.973.2801 Internet: www.algopharm.com email: gtsolakos@algopharm.com Contact Person: George Tsolakos As a worldwide leader in clinical research and bioanalysis, Algorithme Pharma provides a wide range of services in bioequivalence and early stage development (Phase I/IIa) studies to pharmaceutical and biotechnology industries. With over 400 beds, state-of-the-art bioanalytical facilities, and 600 dedicated employees, Algorithme Pharma delivers first-class services to each client. Successfully audited by US FDA, Brazil s ANVISA, France s AFSSAPS, Canada s TPD, UK s MHRA and Austria s AGES regulatory authorities, Algorithme Pharma is committed to on-going dedication to excellence. Services: Analytical Assay Development and/or Laboratory Service, Clinical Pharmacology, Clinical R&D 2 visit www.diahome.org to view our most current, searchable, online directory
HOUSE AD visit www.diahome.org to view our most current, searchable, online directory 3
Almac 1040 Stony Hill Road, Suite 200 Yardley, PA 19067, United States Phone: +1.267.685.4284 Fax: +1.267.685.4262 Internet: www.almacgroup.com email: meghan.adams@almacgroup.com Contact Person: Meghan Adams Take control of your clinical supply chain. ALMAC offers an integrated supply chain management solution that draws from the expertise of our best-in-class clinical trial supplies and IVR/IWR Based services. Our integrated solution does more than just combine related services under one roof; it incorporates supply planning, technology implementation, and project oversight into a unified study start-up and management approach that optimizes the supply chain at each level. How Almac manages this process Lead Almac Contact: A lead Project Manager is allocated to oversee and drive forward the project internally between both disciplines and from an inventory/drug supply management perspective. Shared Master Project Plan: All key deliverable dates are presented in a joint Project Plan, illustrating all milestones for packaging, distribution and the development/implementation of the IVRS. A clear view of the full distribution process: Almac s standardized drug ordering processes allows for consideration of shipping transit times, import licence lead times, depot management requirements and effective management of the kit lists shared between client, distribution and IVRS vendors. Integrated reporting: Almac s integrated web report utilizes data from both clinical trial supply shipping reports and distribution reports from the IVRS. This combined approach permits linkage of IVRS order numbers alongside shipping references and AWB information, providing the full life cycle of drug shipments. One single unique username and password is provided to users for the integrated web report, the clinical trial supply standard web inventory and distribution reports and the standard and customizable IVRS web reports. BENEFITS TO OUR CLIENTS Leverage of joint expertise Reduced vendor management Accelerated study start-up Rapid adaptation to study Services Our clinical technology solutions: IXRS TM (Interactive Voice and epro (Electronic Patient Reported Biostatistical Services Web Response Systems) Outcomes) Adaptive Trial Design Data Integration Clinical Hotline Our clinical trial supply solutions: Clinical trial supplies management Packaging (blistering, bottling, carding) QP release and analytical services Comparator sourcing Labeling of clinical supplies Returns, accountability and Over-encapsulation Global distribution and depot network destruction About Almac: The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors. The company has over 2,500 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company s new $100m North American Headquarters started in July 08 and is expected to be completed late 2010. To find out more about Almac visit www.almacgroup.com Almac Clinical Technologies Almac Clinical Services 1040 Stony Hill Road, Suite 200, Yardley, PA 19067 2661 Audubon Road, Audubon, PA 19403 Tel: +1.267.685.4284 Tel: +1.610.666.9500 email: clinicaltechnologies@almacgroup.com email: clinicalservices@almacgroup.com Services: Clinical Supplies/Distribution/Packaging, Clinical Trial Design, Electronic Diary/Dictionary/Translator, Project Management, Randomization (Automated/Centralized/Vocal Computer), Statistical Services/Meta Analysis 4 visit www.diahome.org to view our most current, searchable, online directory
Almac Clinical Technologies 4-Color AD visit www.diahome.org to view our most current, searchable, online directory 5