Ready for a CRO That Values Performance Over Promises? CHALLENGE. At Clinipace, it s personal.
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1 Ready for a CRO That Values Performance Over Promises? CHALLENGE At Clinipace, it s personal.
2 Who We Are At Clinipace, It s Personal. We Will PROVE IT. With us, you get the A team. We deliver a level of collaboration and control not possible in a traditional contract research organization (CRO) environment. Our goal is to guide you successfully through your clinical development program. Development Regulatory Affairs Technology Functional Services It s personal for the life of your trial. We take pride in building strong relationships and doing what is needed to deliver solutions that move your drug candidate from bench to bedside. We are: Your right-sized CRO Your trusted global clinical development partner Your expert regulatory development consultant Your broad technology infrastructure provider With us, you make the decisions. Not only do we provide resources and expertise when you need them, but we bring experience with us too and experience makes all the difference when you are facing tough questions. We have applied our personal approach to more than 1,500 contract research and 1,500 regulatory drug or medical device development projects worldwide carrying the flexibility to optimize your clinical development protocols, meet aggressive timelines, execute regulatory strategies and complete high-quality trials in a variety of therapeutic areas.
3 Searching for a CRO With Extensive Access Across the Globe? Global Reach We Will BRING IT. We offer a helpful hand wherever you are. With a team of 800 experts in more than 40 countries, we are the right size for any study. We can help you conduct successful multinational studies by gaining operational proficiencies and ensuring consistencies across local regulatory requirements, treatment landscapes and varying standards of care. NORTH AMERICA United States EUROPE Czech Republic France Germany Israel Italy Poland Romania Russia Spain Switzerland Ukraine United Kingdom SOUTH AMERICA Argentina Brazil Peru ASIA-PACIFIC Australia China Hong Kong India Japan Malaysia Singapore South Korea Taiwan
4 Services Expertise for Your Whole Trial. We Will Save money, time and resources. When your new product could change the future of medicine, you don t have time for delays. We are your strategic partner and committed to helping you find success during your drug development journey. Development Global, Personalized Research Solutions We Will BRING IT. Phase I-III Research At Clinipace, our goal is to help you get your new therapeutic to market as quickly as possible while maintaining your milestones. We help you thoroughly understand the safety, efficacy and side effects of your investigational new product, for successful execution of your trial. Phase IV Research Our strategic development team has the expertise and technological resources needed to help you execute your late-phase post-marketing studies. We evaluate health-related quality of life and other patient-reported outcomes for their impact on a patient population.
5 Development Phase I-IV Services We provide a complete list of services for your next trial: Biostatistics and statistical programming data management operations and monitoring staffing technology Investigator recruitment and site selection Medical and scientific affairs Medical monitoring Medical writing Project management Quality risk management Regulatory affairs Safety/pharmacovigilance y Immunology Infectious thopaedic Respiratory Regulatory Affairs Knowledge for Navigating Challenging Regulatory Pathways We Will PROVIDE IT. Moving drugs and biologics from the bench into the clinic and on to market approval requires expansive expertise. From traditional small molecules to advanced biologics, across the complete array of dosage forms and a wide range of therapeutic areas, we will help you navigate complex regulatory processes and advance your program into the clinic. Analytics Finding Quality Information in the Details We Will DISCOVER IT. egulatory Affairs Analytics The success of your trial relies heavily on your ability to answer questions that help you improve patient outcomes and cut costs. Make the most out of your clinical data whether it s quantitative, qualitative or transactional and gain access to a real-time snapshot of your trial status with our clinical analytics services. Staffing Medical and Scientific Affairs
6 Experience That Drives Your Success. We Will DELIVER IT. Team up with qualified scientists and technicians. Therapeutic Areas We have completed more than 1,500 contract research and 1,500 regulatory drug or medical device development projects across a number of therapeutic areas. THERAPEUTIC Our AREAS Focus Areas: Gastroenterology THERAPEUTIC AREAS Gastroenterology (GI) is a rich research environment, but it s also competitive, on ENT Cardiology and changing at a rapid rate. As the landscape changes, we help you meet the stringent requirements imposed by regulatory bodies on all phases of Gastroenterology Immunology Infectious drug development for the treatment of GI disorders. Nephrology and Urology THERAPEUTIC AREAS Oncology SERVICES ENT Nephrology and Urology Orthopaedic - III search Phase IV Research Regulatory Affairs Analytics Nutrition Oncology Orthopaedic Phase I - III Respiratory Phase IV Development Research Research SOLUTIONS SERVICES CNS Nephrology and urology clinical trials include diverse and small patient populations with complex diagnoses and comorbidities, which can bring Respiratory with them both high costs and patient recruitment shortfalls. We know there Nutrition ENT are a myriad of factors to consider and have the ability to ensure efficient recruitment and monitoring of your study s progress and productivity. SERVICES Gastroenterology Immunology Infectious Oncology At Clinipace, we understand oncology study nuances: From the ever-changing regulatory landscape to novel study designs and personalized treatment options, we take care of your entire oncology program. And, we share your passion for advancing cancer research and facing the challenges that bring us closer to a cure. Oncology SOLUTIONS Gastroenterology Immunology Infectious Orthopaedic Regulatory Affairs Respiratory Analytics Complete Therapeutic Expertise: THERAPEUTIC THERAPEUTIC THERAPEUTIC AREAS AREAS THERAPEUTIC THERAPEUTIC AREAS AREAS AREAS Biostatistics and Data Medical and tistical Programming Management Staffing Scientific Affairs Phase I - III Technology / Phase IV Regulatory Cardiology Functional Cardiology CNSBiostatistics and Cardiology ENT CNS Gastroenterology Data ENT CNS Gastroenterology Immunology ENT Gastroenterology Immunology Infectious Medical and Infectious Immunology Infectious Research Clarity Stack ResearchCardiology Services Affairs CNS Cardiology CNS Statistical Programming AnalyticsENTENT CNS Gastroenterology ENT Management Staffing Immunology Gastroenterology Infectious Immunology Scientific Affairs Infectious AS SOLUTIONS ct Quality Risk Safety Nephrology / Nutrition Nephrology Site Oncology Nutrition Nephrology Orthopaedic Oncology Nutrition Respiratory Orthopaedic Oncology Respiratory Orthopaedic Respiratory rology Immunology Infectious Nephrology Nutrition Nephrology Oncology Nutrition Orthopaedic Oncology Respiratory Orthopaedic Respiratory ment Management Infectious and Urology Pharmacovigilance Selection and Urology and Urology and and Urology Urology and Urology and Medical Vaccines Project Quality Risk Safety / Site Writing Management Management Pharmacovigilance Selection al Biostatistics and Data SERVICES SERVICES SERVICES SERVICES SERVICES Medical and
7 Return on Your Investment. We Will DELIVER IT. Solutions Technology Technology That Advances Your Trials We Will BUILD IT. While all clinical research trials are using some level of e technology, the systems often operate in silos, making data collection, analysis and reporting cumbersome. Clinipace s Clarity Stack clinical technology will bring clarity to Clarity Stack your clinical trial through a continuous flow of integrated information and a secure, holistic view of your clinical research trials. ecoa IRT Safety Stat Prog EDC Clarity Flow POWERED BY ADAPTIVE CLINICAL Data Warehouse Clarity Insight Feasibility SSU etmf CTMS TOP ROW: EDC: Medidata, Medrio ecoa: ERT Safety: Oracle Argus BOTTOM ROW: IRT: endpoint, Mediata Functional Services Statistical Analysis: SAS Feasibility: Trial Interactive Support for Your Core Capabilities We Will ACCOMPLISH IT. Site Start Up: gobalto Activate etmf: Trial Interactive CTMS: Bioclinica Onpoint Clarity Insights: Powered by Microsoft Power BI We have the support and services you need, when you need them. Our team takes your trial personally and we function as a direct extension of your organization, dedicated to the success of your trial. Services: Biostatistics and statistical programming data management staffing solutions Medical and scientific affairs Medical writing Project management Quality risk management Safety/pharmacovigilance Site selection When you have clinical research and development questions, the answer is Clearly Clinipace.
8 2018 Clinipace Inc
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