sponsors

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THANK YOU TO OUR CONFERENCE PARTNERS & EXHIBITORS:

For more information on how to become a Conference Partner and or Exhibitor Opportunities, please contact:

Kelly Murphy, Vice President, Business Development, iiBIG

Tel: 516-442-0176 • Email: info@iibig.com

The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.

For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com

Aspire Independent Review Board provides customized IRB services to meet the unique needs of our clients in all phases of clinical research. We are committed to the highest level of human research protection with an emphasis on flexibility, efficiency and a commitment to customer service.

Aspire IRB is fully accredited by AAHRPP.

Bio-Optronics is an established and trusted provider of unique workflow management software solutions that have been helping healthcare professionals manage and optimize their workflows for over 27 years. Over those years, Bio-Optronics has become an industry leader in a variety of healthcare fields, and has demonstrated leadership in innovation, expertise in workflow and integration with a focus on unparalleled customer service. The Clinical Conductor™ family of products, in use at over 1,400 sites around the world, provides sites, AMCs, SMOs, CROs and sponsors with detailed study management tools to make recruitment easier, financials more streamlined and trials more efficient and accurate. Users of the Clinical Conductor CTMS software solutions have access to unparalleled customer support and training. Working in tandem with our software development team, our customer support staff will ensure that our software is enhanced as your needs evolve. For more information about Clinical Conductor CTMS, please visit our website. www.bio-optronics.com

Boston Biomedical Associates is a full service Clinical Research Organization, committed to advancing the most efficient and cost-effective path to device approval. Our partnering philosophy emphasizes our uncompromising commitment to research and to the highest level of ethical standards and performance in our jobs. BBA's dedicated team provides aggressive strategic consulting; to meet our client’s needs by delivering high quality services in every phase of the trial. Our clinical, data management, statistical and regulatory experts are dedicated to efficiently moving from strategic planning to device approval. We want to be your strategic partner for the entire medical device lifecycle.

The path to developing a world class research program is intricate and detailed. As a company, BRANY’s core objective is to be the nation’s preeminent clinical trials service provider, offering an array of comprehensive and efficient support services to organizations conducting research.

Over the last thirteen years, BRANY has worked diligently to develop a strong infrastructure of services that support researchers and organizations in their pursuit to conduct quality research. BRANY’s unique model offers organizations Local/Central IRB, Study Identification, Billing Compliance, Research Education and Research Compliance Services. www.brany.com

Clinical Financial Services (CFS) is a specialty provider focused on the business and financial management activities for clinical trials. The company offers a unique blend of contract, regulatory, and cutting edge investigator grant payment management services which operate in unison to accelerate cycle times, manage compliance and risk, and stimulate investigator relationships. With our focused expertise, innovative processes, and integrated technology we are able to provide high quality, cost effective service solutions that address critical study startup and financial issues affecting the clinical trials process.

At Clinical Resource Network, LLC (CRN), we make clinical trials “patient-centric” by bringing the clinical trial to patients wherever they live, work or play. We have been deploying our international network of in-home nurses since 2003 to increase patient enrollment and retention. Perfecting how we conduct mobile clinical trials is our sole focus. We can execute a “patient-centric” model well because we have highly experienced teams with diverse backgrounds in big Pharma, healthcare, clinical research trials and logistics management. As a result, we deliver evaluable results on time and on budget.

Clinverse provides the industry’s first fully automated, global, SaaS-based financial management network for investigator and other vendor payments; our flagship product, ClinPay™, efficiently automates and facilitates the entire investigator payment process from contract execution through site payment. It provides complete transparency for Sponsors, CROs and Investigators, offering near real-time transaction and payment information for all involved in the network. We are integrated with various e-Clinical systems to receive study data, which triggers payment milestones in ClinPay, eliminating duplication of data entry. Clinverse’s patent-pending technology platform supports payments in 140 currencies, is fully customizable, and provides a cost effective solution for investigator payments. Please call 1-877-325-1122 or visit the Company’s website at www.clinverse.com

Confluent Translations’ mission is to go beyond translation to honest understanding through ongoing dialog with clients to ensure success. We are ISO 9001:2008 certified dedicated to providing quality work in a timely manner. Our name reflects the company’s customer centric philosophy by merging the client and Confluent in a fluid process to obtain a positive outcome. Good translation and cultural training can make everything a company does fall into place internationally. You, your end customers, partners, and employees will appreciate the joy of engaging with people, products and processes in their first language. That’s the most respectful and profitable way to conduct business globally. “Reliable and responsive” are words we hear every day from our clients. Visit www.confluenttranslations.com or call Nancy Cardone at 412 539 1410 x 101 to make sure your message is clearly delivered.

CROfessionals, Inc. is a fixed-price, customer service oriented Contract Research Organization located near Washington, DC. We offer services in Clinical Trial Management and Regulatory Affairs consulting and operations in the US, EU and Asia. We have over 20 years experience in the clinical development of biologics, plasma products, rare diseases, gene therapy, emerging biotechnologies and small molecules.

We help you bring promising products and therapies to life, on time and on budget. www.crofessionals.com

Drinker Biddle & Reath LLP, with 650 lawyers in 11 offices nationwide, provides clients with unparalleled service in matters ranging from billion-dollar deals to complex class actions, across a broad spectrum of industries including life sciences and health care. Our priorities are knowing our clients' business and providing the value they need so that we can be an integral part of their success. Clients choose us for our sophisticated yet efficient approach to handling their most important work, including business transactions, litigation and government affairs efforts. For more information on how we have been innovating for clients for more than 160 years, please visit www.drinkerbiddle.com.

Forte Research Systems develops clinical and translational research management software. The company’s cloud-based Allegro® Research on Demand product line includes the Allegro CTMS@Site™ system for clinical research sites and disease groups engaged in industry-sponsored clinical trials, and the Allegro CTMS@Network™ system for trial and site management organizations and investigator site networks.

ease visit www.ForteResearch.com

Greenphire is the leading provider of clinical payment solutions. Greenphire’s globally scalable technologies—the ClinCard System and eClinicalGPS—enable users (sponsors, CROs, and sites) to electronically calculate, approve, and deliver payments to investigators, vendors, and trial participants. Greenphire’s solutions support 60,000 subjects across 11,000 studies at 1,600 clinical trial sites. www.greenphire.com

HealthCare Appraisers, a nationally recognized valuation firm, provides fair market value analysis and consulting services exclusively to the healthcare and life sciences communities for:

•HCP compensation arrangements involving KOL’s and thought leaders for speaking, consulting, training, advisory boards, and research

•Clinical trials arrangements and transactions

•Intellectual property and royalty-based licensing arrangements

•Data-set acquisition and licensing transactions

•Business valuation for acquisitions, leases and divestitures

HealthCare Appraisers, Inc.

Delray Beach • Denver • Dallas • Chicago • Philadelphia

Tel: (561) 330-3488 • www.HealthCareAppraisers.com

Huron Life Sciences’ Clinical Research Management solutions enhance financial performance, compliance, service levels, and efficiency across the research enterprise for hospitals, academic institutions, and independent research organizations. Our depth of experience, customized approach, and focus on implementation help clients achieve optimum results. Huron’s Click™ Portal software enables institutions to consistently budget, code, and bill trials correctly; improve cash flow through timely sponsor billing and collections; and negotiate better contracts — all with a single, integrated, configurable solution.

Since 1999, IntegReview IRB’s customer-driven business environment focuses on protecting the safety of human subjects who participate in clinical research and ensuring compliance with appropriate federal regulations.

Offerings include; 6 weekly meetings, Canadian review, same day site review, 24 – 48 hour service, translations and consulting. We provide high standards of quality, ethical integrity and regard for human safety while being responsive to customer demands and needs for prompt, thorough and professional services.

In 2007, full accreditation was earned from the Association for the Accreditation of Human Research Protection Programs.

IntelliTRIAL™ is a comprehensive software package (CTMS) that focuses on managing the financial aspects of research. Designed for sites that conduct phase 2 and 3 trials, we emphasize budgeting, compliance tracking, invoicing, forecasting, and receipts/payments. Our reports and features provide a complete financial picture for each study and the tools to help sites make sure they are being compensated fairly and completely for all the work they do. We are a solution that works well for sites of all sizes, and we provide extensive ongoing support and training services to help our customers make the most of their investment. www.intelliTRIAL.com

Meade & Roach, LLP distinguishes itself as a law firm focused on delivering practical solutions for healthcare regulatory compliance needs. Each of our partners has more than a decade of focused, industry-leading experience in this area. The results we have achieved for clients speak for themselves. We not only understand the law, we understand our clients—who range from the country’s largest academic medical centers and hospital systems to stand-alone specialty facilities and physician practice groups.

Medidata Solutions is a leading global provider of SaaS clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced solutions lower the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our customers include biopharmaceutical, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, encompassing 20 of the top 25 global pharmaceutical companies as well as research organizations of all sizes. www.mdsol.com

Mossman Associates offers diagnostics for patient enrollment screening, when knowledge of Nicotine, Alcohol or Drugs of Abuse consumption is required. Our rapid tests are, reliable, affordable and do not require instrumentation. Regardless of the requirements that you might have during enrollment, we can offer saliva, breath or urine options. Tests are FDA cleared and many of these tests are CLIA waived, including the only CLIA waived semi-quantitative urine test for nicotine. With our Carbon Monoxide monitors and saliva cotinine test we can meet all your nicotine, alcohol or drug of abuse screening needs. www.mossmanassociates.com

Neal, Gerber & Eisenberg LLP is a Chicago-based law firm providing legal services to a diverse group of clients in a wide array of domestic and global business transactions and litigation matters. Our clients include privately and publicly held companies, financial institutions, not-for-profit organizations and high net worth individuals. Our client base reflects virtually every business industry, including a number of Fortune 100 companies. The firm is comprised of over 200 attorneys spanning 23 practice groups (including Life Sciences) who share common values of integrity, a dedication to high quality legal services and a commitment to diversity. Website: www.ngelaw.com.

Optum™ is an information and technology-enabled health services business platform serving the broad health marketplace, including care providers, plan sponsors, life sciences companies, and consumers. Its business units—OptumHealth™, OptumInsight™, and OptumRx™—employ more than 30,000 people worldwide who are committed to enabling sustainable health communities.

The people of Optum serve care providers, including 250,000 professionals or groups and 6,200 hospital facilities; more than 270 state and federal government agencies; over 2,000 independent health plans; two of every five FORTUNE 500 employers; 2,200 global life sciences companies; and one in every five U.S. consumers. They help organizations address significant challenges such as improving clinical performance, implementing new models for care delivery and reimbursement, complying with new regulations, and reducing administrative and financial burdens. Optum’s deep understanding of the needs of the multiple participants across the health ecosystem enables it to deliver collaborative solutions that provide the insights and care to help build sustainable health communities.

PCM TRIALS has been providing alternate-site visits since 2008. PCM TRIALS’ approach of directly hiring, training and managing Certified Mobile Research Nurses (CMRNs), rather than subcontracting to local home health agencies, removes significant risk and administration normally associated with clinical trial home-visits. PCM TRIALS’ CMRNs have completed thousands of alternate-site visits across a wide range of therapeutic areas throughout the US. Sponsors, CROs, and Sites see a significant improvement in recruitment and retention, which accelerates trials and reduces costs with the same quality and care as on-site visits. For additional information go to PCMTRIALS.com

Pearl Pathways is a comprehensive life science product development services company. Our experienced team is obsessed with expediting life science product development regulatory pathways. We have three business units to serve you:

Pearl IRB is a full service commercial Independent Review Board that provides human research IRB reviews, IRB exemptions and waivers, and also offers support for research protocol/ICF medical writing, site assessments, and monitoring services.
Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance, conducts global health authority negotiations, develops/improves quality systems, and delivers GMP/GLP/GCP auditing services.
Pearl IDEAS provides strategic product development assistance, third party vendor selection and management strategies, due diligence services, and sales and marketing services for drug, biologic and device companies.

To learn more, please visit us at www.pearlpathways.com, call us at 317.899.9341, or email contact@pearlpathways.com. Pearl Pathways is located in Indianapolis, Indiana, and is a WBENC certified woman owned business. For media inquiries, contact Diana Caldwell at dcaldwell@pearlpathways.com.

Quorum Review is an independent ethics review board that is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Our primary focus is to safeguard the rights and well-being of research participants. We provide sponsors, CROs, institutions, and sites with reliable, responsive service that ensures efficient study start-up and management. For more information, visit www.QuorumReview.com

Novel Approaches to Patient Recruitment
RESolutions, LLC was founded to meet the unmet need of providing proven patient recruitment programs to small-mid size pharmaceutical & device companies, Contract Research Organizations (CROs) and trial sites. Visit www.resolutions-llc.com or call us @ 858-350-0011 to see the novel ways in which we can come along side your trial sites current recruitment efforts to ensure your trial is enrolled on time and on budget.

Schulman Associates IRB has been a leading provider of review services in the US and Canada since 1983. Schulman is AAHRPP accredited and has an unparalleled FDA audit history. Schulman offers a full line of IRB services including expedited protocol review for minimal risk research, informed consent writing, rush review, translations, and real-time eTools for securely submitting documents, tracking the review process and downloading approval documents. In 2011, Schulman acquired Independent IRB, an industry leader in Phase I review service. The transaction allows both organizations to provide one of the most comprehensive suites of review services in the industry.

SNR Denton is a client-focused international legal practice delivering quality and value. We serve clients in key business and financial centers from more than 60 locations in 43 countries, through offices, associate firms and special alliances across the US, the UK, Europe, the Middle East, Russia and the CIS, Asia Pacific and Africa, making us a top 25 legal services provider by lawyers and professionals worldwide.

TrainingCampus.com® is the home of The International Electronic Education Network®. It is both a production area and a market place where members can get discounted products, services and specialties, build educational material to be sold, exchanged or distributed to any arena requiring training, assessments and surveys. We provide the most efficient means of documenting competency for evidence based education.

TTC, llc is the leader in creating, delivering and maintaining state of the art clinical cost benchmarking tools. TTC’s client companies include most of the top 20 Pharma and 6 of the top 10 CROs. TTC llc provides 4 key offerings to the pharmaceutical and biotechnology industries: GrantPlan® provides Fair Market Value for creating, negotiating and defending investigator grants. CRO CostPro® provides detailed budgeting and quick forecasting & customized format with on-line negotiation. IISiS™ provides Fair Market Value for investigator initiated studies ensuring payments to the sites are within clinical compliance. The Standard of Care Tool is the first and only database on the market that provides current trends in Standard of Care identifying those procedures in a protocol that are currently paid by 3rd party payers. Our database is: The largest – TTC’s subscribers conduct 76% of all clinical trials worldwide. The most current – TTC’s data is no more than two years old and is updated quarterly. The most accurate – TTC’s data is comprised of only final negotiated grant contracts and final approved CRO proposals. The best defense – for being compliant in fair market value payments to physicians.livepage.apple.com

XaitPorter is a 100% web based software application that allows you to produce proposals, contracts, NDAs, project documentation, and all other critical business documents up to 70% faster. XaitPorter lets several people work on the same document – all at the same time in true collaboration style. Porter automatically takes care of all the formatting (i.e. fonts, styles, figures, numbering, referencing and layout) according to your marketing guidelines, which allows you to focus more time on what matters most, your content. Please stop by our booth in the Exhibitor’s Lounge – at the MAGI Conference.

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