BioClinica 826 Newtown-Yardley Rd. Newtown, PA 18940 Phone: 800-392-7456 Fax: 267-757-3010 www.bioclinica.com Discover the Power of a New Combination BioClinica, Inc. is a leading global provider of integrated, technology-enhanced clinical trial management services. BioClinica supports pharmaceutical and medical device innovation with imaging core lab, internet image transport, electronic data capture, interactive voice and web response, Microsoft Office-Smart clinical trial management, and clinical supply chain forecasting and optimization solutions. BioClinica services maximize efficiency and manageability throughout all phases of the clinical trial process. With more than 20 years of experience and over 2,000 successful trials to date, BioClinica has supported the clinical development of many new medicines from early phase trials through final approval. Visit us at www.bioclinica.com to learn more. The Harte Group 101 Edison Furlong Rd. Doylestown, PA 18901 Phone: 215-766-2397 www.hartegroup.com Redefining the Clinical Trials Process Full Service Team: The Harte Group team will evaluate, select and manage the best team of niche service providers to execute the program. The Harte Group has identified over 75 vendors, employing over 11,000 professionals globally, who are available to provide just the right services to meet project needs. A La Carte Service: The Harte Group works closely with sponsors to identify their support needs and is able to provide vendors and/or individuals best suited for the opportunity. Consultation: With a collective 100 years of industry experience, The Harte Group is able to assist companies by complementing their leadership teams and supporting their growth with a qualified suite of experienced vendors. ClinForce LLC 4815 Emperor Blvd. Ste. 300 Durham, NC 27703 Phone: 919-941-0844 Fax: 919-941-0071 www.clinforce.com Resource Solutions Contract Staffing – experienced, qualified professionals working under your leadership and management to supplement your internal project team or departmental personnel. Direct Hire – experienced, talented professionals screened against your specifications and referred to you for direct hire as regular employees of your organization. Functional Outsourcing – teams of disciplined-based professionals are recruited to meet your specifications and needs, providing general or project-dedicated services to your organization. Typically located off-site at a ClinForce facility or virtually located throughout the country, logistical and functional management is provided by ClinForce personnel while the client retains true project management responsibilities. i3 131 Morristown Rd. Basking Ridge, NJ 07920 Phone: 800-765-6071 www.i3global.com The Company of Specialists i3 is a full-service, global contract research company providing clinical research services for biotech and pharmaceutical clients. I3 takes a 360-degree view of health care to help its global pharmaceutical, biotechnology, and medical device clients bring safe and effective products to market quickly and help demonstrate their value, leading to increased ROI and better patient care. ERA Clinical 71 Union Ave. Ste. 110 Rutherford, NJ 07070 Phone: 201-842-7621 www.eraclinical.com Innovative Late Stage Clinical Trials Our Mission is to offer an alternative to post-marketing clinical practices through innovative programs that focus on the relationships between practitioners and their patients. We partner with organizations like Multi-specialty Group Practices and National organizations of Nurse Practitioners to develop lasting relationships while improving the quality and efficiency of clinical trials. Our trials characterize and differentiate drugs and devices as to demographics, effectiveness, tolerability and practitioners’ global impressions . All trials are conducted under strict regulatory compliance and in accordance with published Industry guidelines. INC Research 4700 Falls of Neuse Road Suite 400 Raleigh, NC 27609 Phone: 919-876-9300 Toll Free: 866-462-7373 Fax: 919-876-9360 www.incresearch.com Therapeutic Foresight. Trusted Results. For more than two decades, INC Research has been a therapeutically focused contract research organization with an unrivaled reputation for conducting global clinical development programs of the highest integrity. The company’s Trusted Process® method of conducting Phase I–IV trials means its customers experience certain trial excellence, helping to minimize potential risk factors and leading to more informed and confident development decisions. Pharmaceutical and biotechnology companies look to INC Research for customized worldwide trial services, as well as functional service needs, that end with results they can trust. MediciGlobal 1014 W. 9th Ave. King of Prussia, PA 19406 Phone: 484-674-6800 Fax: 484-674-6356 www.MediciGlobal.com Recruitment. Retention. Results. MediciGlobal is a specialist clinical trial recruitment–retention agency. At Medici, the patient is at the heart of everything we do, but we also understand that time is money. Head Start to Recruitment™ allows us to both understand the patient better, and to fast-track recruitment, often starting the process several months ahead of study start. As a global agency, we are committed to working “glocally" — planning globally and adapting and implementing locally. Using ADapt®, we quickly and efficiently customize patient materials right down to the site level, ensuring local relevance and resonance. With expertise in online and traditional marketing, and media buying, an in-house call center and lost-to-follow-up team, we are perfectly positioned to help you achieve clinical trial success. Outcome 201 Broadway Cambridge, MA 02139 Phone: 617-621-1600 Fax: 617-621-1620 www.outcome.com Patient Registries, Studies, and Patented Technology for Evaluating Real-World Outcomes Outcome is the market leader in patient registries, peri- and post-approval studies, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed, developed, and managed an industry-leading number of patient registries including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Email us at [email protected]. Medidata Solutions Worldwide 79 Fifth Ave., 8th Fl. New York, NY 10003 Phone: 866-515-6044 Fax: 212-918-1818 www.mdsol.com Technology for a healthy world.® Medidata Solutions is a leading global SaaS provider of clinical development solutions that enhance the efficiency of customers’ clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata’s advanced solutions address key functions throughout the clinical development process including protocol development, trial planning and management, user and learning management, randomization and clinical supply management, monitoring, Serious Adverse Events capture and clinical data capture, management and reporting. Research Dynamics Consulting Group, Ltd. 1250 Pittsford Victor Rd. Bldg. 100, Ste. 110 Pittsford, NY 14534 Phone: 585-381-1350, x283 Fax: 585-381-4032 www.resdyncg.com Delivering Real-Time Data and Confidence™ For 20 years Research Dynamics’ three divisions, CRO, Training, and Consulting services have provided “state of the art" services and clinical research expertise. Our CRO services concentrate on our core clinical services (phases I – IV) from site selection to monitoring to final database lock/statistics. Our training division provides GCP and other clinical research training. Our experience includes teaching thousands of students and participation in development of industry certification programs/tests. Our expertise extends to our GCP training books and SOP templates. Our consulting services span several areas of expertise such as FDA audits that improve the processes and quality of clinical research. We are known for delivering quality data in real-time, on-time, and within budget. Merge Healthcare 4000 Aerial Center Pkwy. Ste. 101 Morrisville, NC 27560 Phone: 919-653-3400 www.merge.com/eclinical Re-energizing Clinical Trials Merge develops solutions to automate healthcare data and diagnostic workflow to enable a better electronic record of the patient experience, and to enhance product development for health IT, device and pharmaceutical companies. Merge solutions, ranging from standards-based development toolkits to sophisticated clinical applications, have been used by healthcare providers, vendors and researchers worldwide for over 20 years. Merge provides etrials software and services to pharmaceutical, biotechnology, medical device, and contract research organizations, offering adaptive, integrated Web-based tools to coordinate data capture, electronic image management, patient interaction and trial management – turning data into intelligence and shortening the pathway to an actionable study endpoint. Waife & Associates 62 Warren St. Needham, MA 02492 Phone: 781-449-7032 Fax: 781-444-1763 www.waife.com Change Management for Clinical Research Our senior domain experts have consulted to the largest and smallest biopharmas, CROs and academic institutions, as well as service/product vendors and their investors. Typical projects include: • Clinical operations strategies (outsourcing, governance, skill evaluations) • Organizational Preparedness™ for major process change (such as functional outsourcing) or technology adoption (such as EDC or a change in document management/pharmacovigilance applications). • Diagnosis of non-value-added work processes • Implementation of EDC, CTMS, AES, ePRO, IXRS, CDR, DMS and related technologies • Virtual executive services in clinical development, data management, information technology.
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