Arroyo Research, Inc.

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Companies need a proven partner that can assemble and deploy all the necessary capabilities required to fulfill various activities of clinical research and regulatory requirements. Our Clinical Operations combine medical monitoring, product safety, clinical monitoring, and project management to provide our customers with exceptional clinical trial management services. We strive to create highly collaborative relationships with our clients to deliver fast, successful, and scientifically sound deliverables project. Every member of our clinical operation team works internally and with the client, from the initiation to the closure, to maximize project performance, clinical excellence, data integrity, and product safety. ARI proficient and experienced team members engage quickly and provide strategic thinking – ensuring quicker start-up times, superior quality, and the most efficient delivery at every phase of trial.ARI dedicated clinical operation teams are designed to serve as an extension of your team and provide unrivaled support at every stage of the drug development process. Comprehensive communication throughout all phases of the clinical trial is essential to building successful partnerships with Sponsors, research sites, and patients. ARI Clinical Research Associates (CRAs) work hard so they can delve into your study and analyze the entire plan; and they work in concert with management across the globe ensuring you always receive the personalized service you deserve. We share common goals and expectations regarding drug development and are committed to your success. ARI Clinical Operations provides support in a number of critical areas, including:• Clinical Trial Submission • Investigator Selection • Investigator Training• Patient Recruitment• Clinical Monitoring• Clinical Trial Management Site Selection and MonitoringARI's has a network of clinical investigators and medical sites that are actively participating in clinical trials. Through partnerships with academic institutions, existing relationships with high-quality sites, as well as feasibility assessment techniques, ARI achieves study timelines by providing clients with high-quality investigators for accelerated study completion. ARI identifies qualified investigators based on study-specific requirements and the sponsor's preferences. Our Investigator Database provides a wide selection of qualified investigators to participate in clinical trials. The database contains detailed information regarding Investigators and Research Staff. ● Medical DevicesARI is the best choice for medical devices consultancy for clients looking for practical advice and support throughout the life-cycle of a medical product from assessing the regulatory pathway, clinical trials and quality system implementations - to product approvals, reimbursement and post-market surveillance. Our mission is to provide our clients knowledge, integrity, and ingenuity within a suite of integrated services, to successfully take their products from concept to market.ARI goal is to provide you with a full spectrum of services that help you meet the requirements of the Medical Device Directives (AIMDD and MDD), the In Vitro Diagnostics Directive and related directives. ARI provide expertise service in:• Regulatory affair & submission• Clinical trial design & management • Database development & compliance • Reimbursement strategy and implementation • Health economics • Quality systems & compliance • Biostatistics • Preclinical research • Venture capital due diligenceARI helps medical device companies bring products to market – and keep them there – by efficiently and cost-effectively providing the right regulatory, clinical development and post-approval programs. We help you to:• Plan and execute clinical trials • Prepare documentation, such as: o 510(k) o IDEo PMAo PDPo CE Mark submissions• Design quality systems • Develop reimbursement strategies• Meet post-marketing surveillance requirements

EMERGING REGION REGIONS

EMERGING REGIONS

Arroyo Research is a global, Contract Research Organization (CRO) providing phase I-IV clinical research support to biotechnology, pharmaceutical and medical device companies. ARI is committed to the success of our client’s clinical research programs by providing uncompromising quality and cost-effective services.Arroyo Research has established its presence in Southeast Asia, Japan, Latin America, Central & Eastern Europe and Middle East. As markets are being identified for research, our team is already on the ground and well-prepared to start trials quickly and keep them on track. ARI’s global investigator database helps our clients to select experienced sites with broad range of therapeutic indications. Major advantage of conducting clinical trials in each of these emerging regions is cost and time savings. Advantages to a Global Presence• Enhanced communication through multilingual staff, thereby facilitating communication between sites, regulatory bodies and our clients• Local expertise means we are familiar with local regulations and research practices• Regional proximity to investigational sites, in North America and around the world, reduce travel expenses -- offering cost efficient service

CONSULTING

ARI provides our clients with a data driven recommendations and advice to make better fact-based strategic business decisions to help them achieve success.We provide our clients with a ground breaking research, market analysis and industry insight, to help with product development decision. ARI can help you navigate the complex process of clinical trials and variables to help you navigate the process to save you time and minimize costs. ARI value the relationship and communication between patients, doctors, care givers, and regulatory agencies. We develop marketing strategies which help you make decision about pricing, customer support and marketing access.ARI consulting team strives to promote innovation, for the reality of personalized therapy, and improve patient access to treatments. ARI commit to our clients to continue our pledge, to adhere to a strict code of ethics and maintain the highest integrity.We can save you time and resources with our consulting services in a number of critical areas of the clinical trial process. Our consulting services include;• Protocol design• Clinical regulatory support• Statistical support• Submissions regulatory support• Data standards

CAREER

ARI offers a broad range of career opportunities. We're looking for people with leadership qualities and initiative to share our unique vision. We place a strong emphasis on the growth and development of each of our Associates. If you're looking to advance your career, submit your resume to: trials_arroyoresearch.com

CLINICAL OPERATIONS
EMERGING REGION REGIONS
CONSULTING
CAREER

ABOUT US

Arroyo Research, Inc. (ARI) is a trusted and dependable partner that focuses on providing quality clinical development services to the pharmaceutical and biotechnology industries. ARI's unique approach to clinical research allows for timely execution and quality results for the clinical trials we manage. ARI accelerates clinical trials with experience and technology to provide you with the assistance you require. ARI can act as your clinical team, safety monitor, regulatory staff, data manager or medical writer whether you require comprehensive assistance or support in specific areas. ARI customizes a wide range of services for Phase I to Phase IV clinical trials, including data and project management, pharmacovigilance, medical writing and statistical analysis. These services are offered separately or as cost effective integrated processes. ARI’s clinical research team has extensive experience in a broad range of therapeutic areas. Our network of professionals extends from coast to coast and globally, we are committed to providing your business with superior services at lower cost.
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VISION & VALUES

ARI strive to provide clinical research management, study monitoring, data management, quality assurance, and medical writing services of consistently superior quality, on time and on budget to all of our clients. Our vision is to transform the clinical trial process to one of extraordinary results and satisfaction for our clients as well as for our employees and all stakeholders.ARI strives to be the premier service provider to the healthcare products industries. We are committed to delivering value, benefiting patients, clients, employees and shareholders through innovation, orientation, sound business management and dedication to excellent service.Client Service: We strive to understand our clients' needs and to meet or exceed their expectation with high quality customer service. We are flexible and always look for proactive, responsible solutions to ensure client satisfaction.Timeliness: Our orientation demands that we address issues and requests immediately, reasonably and comprehensively.Open Communication: We share information, expertise and experience with our clients. At any given moment we may be students, mentors, teachers or consultants.Teamwork: Sound strategy and creative implementation require diverse talents working in unison. Best Value for our clients depends on everyone's cooperation and mutual support.Commitment: Our commitment to our clients is to:• Meet or beat agreed-upon schedules • Meet or exceed industry quality standards • Provide unprecedented levels of teamwork, • communication and partnership with all stakeholders • Earn our clients trust • Provide value to all our clients
SERVICES

YOUR TRUSTED PARTNER IN RESEARCH

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MUSIC

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PHASE I

ARI provides customized Phase I clinical trial services to advance our clients' products to the next development phase.ARI focuses on safety and data integrity through strategic study design to achieve your phase I objective on time with reasonable cost. Our electronic case report forms (eCRFs) for database development are fast and reliable. We have the experience and local presence to promote your success, which we believe is dependent on accuracy and well executed project management. Our innovative and adaptive study designs with the support of the key opinion leaders and investigators ensures accurate, quality data to help you make faster, better informed decisions. For all of our Phase I trials, we provide robust research capabilities, including medical writing, clinical data management, statistical expertise in pharmacokinetic and pharmacodynamic analyses, and experimental design, including adaptive design options.Project Management ARI has the experience and local presence to promote your success, which we believe is dependent on well executed project management. Every ARI project manager is responsible for communicating with the client, ensuring accuracy, creating a management framework and employing risk management processes to address potential obstacles. ARI has built a reputation for excellence based on successful execution of these responsibilities. Trust ARI to manage the complete clinical trial process, including planning, patient and investigator recruitment, data management, biostatistics, clinical pharmacology, regulatory compliance, and much more. Clinical Monitoring ARI’s clinical monitoring team works with your company to ensure your product’s quality. Whether your clinical trial effort requires an assistant, an advisor, or a full partner, ARI has the tools to make your vision a reality. Our CRAs are some of the best in the industry and are located across the U.S. All our CRAs receive up to date interactive, computer-based GCP Training. They are trained in Adverse Event Reporting and regulatory affairs. Most of our CRAs has earned CCRA accreditation with many years of experience and are dedicated to building relationships with Investigators and Coordinators. Our monitors ensure quality investigators, oversee data collection, review documentation and forms, ensure regulatory compliance, resolve data queries and conduct analyses as they are requested. Our phase I services includes but not limited to: • Protocol development • Clinical execution• Project management • Subject recruitment • Safety management • Data management

PHASE II AND III

PHASE II & III

Our experience, support systems and infrastructure enable us to provide the highest level of program management and services for Phase II-III clinical trials. We assist our clients in advancing their products through development and approval on time and within their budget. Our experienced team delivers quality results for our clients' drug development needs. Our innovative scientists, clinicians, regulators and health economics experts are committed to meeting the highest quality standards. We are committed to meet the challenges of clinical trial design and management so that you receive useable, clean data within budget, on time, every time.We offer a broad range of services that allows us to provide capacity and experience in clinical trial management. Quality Assurance We routinely audit our own work and provide QA audit services to our clients as part of our commitment to integrity and high quality. Our QA service is offered to our clients as a part of a full service or a standalone project. ARI's quality assurance group can act as external auditors to ensure the integrity of your data and advice you on way to verify the integrity of your data and to ensure adherence to protocols and regulatory guidelines. We can assist you in preparing document to be submitted to regulatory agencies and QA audits help to simplify and support your passage through the approval process.ARI conducts Quality Assurance Audits:• During Study Conduct • During MIS Validation Steps • Before Database Release • During Preparation of Clinical Summaries and Regulatory SubmissionsARI QA team is knowledgeable about local, national, and international regulation, standards and guidelines.Among the clinical quality assurance audits we conduct are: • Clinical investigator site audits. We provide routine, directed, specialized and pre-inspection audits to help sites prepare for regulatory agency reviews • Clinical database audits and study report reviews • Clinical study document reviews • System audits in which we assess client standard operating procedures (SOPs), processes and staff training programs and recommend improvements where needed • Vendor audits in which auditors evaluate a client's vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations ● Lab ServicesARI Central Laboratory Services is among the world's leading provider of clinical trial laboratory services, dedicated to testing specimens and resulting and reporting data.ARI central Laboratory Services develop and implement a customized, protocol-specific database and visit-specific collection kits for clinical studies for the collection of more complete and accurate data. As a result of our improved processes for collecting higher-quality laboratory data, pharmaceutical companies have achieved faster data locks and product submissions. Our reach and experience spans the globe with strategically placed facilities in Asia, Europe and the Americas all bound by company SOPs and a unified Information Management and Reporting System. ARI Central Laboratories offer virtually every central laboratory service you need, including standardized assays, integrated data management, international laboratory study coordination and site support. Our project management, specimen chain of custody processes and scientific expertise are complimented by our resources to perform nearly all of the analysis required to support a clinical study within our systems. We offer a wide range of analysis that include;• Autoimmune profiles • Biochemistry • Coagulation studies • Diabetic profiles • DNA extraction and storage • Endocrinology • Flow cytometry • Hematology • Infectious disease serology • Inflammatory/ immune markers • Lipid profiles • Unique biomarker profiles• Virus antigen detectionWe offer: • Comprehensive list of services • Extensive reach • High level of accuracy.

POST APPROVAL

ARI team provides you with a global perspective for the late phase studies and assists you in your post approval strategies. We have the experienced staff to assist you in the operational understanding of the challenges involved in conducting global and regional post-Approval studies. Our team consists of industry-leading strategic, scientific, medical and epidemiological experts in Late-Phase Operations. We customize our services to fit your need and fine-tune it across the globe, to meet local regulatory requirements.Our service offerings include:• Medical Writing• Product Safety • Clinical Operations• Biostatistics & Statistical Programming• Clinical Data Management• Regulatory Affair• Quality Assurance• Project Management• Product Safety and Pharmacovigilance• Medical Device DevelopmentOur post approval services provide comprehensive planning on a global scale. Our experts maintain an in-depth and current understanding of all evolving regional and local regulatory requirements necessary to ensure our clients of a successful post-marketing study. Our post-marketing studies helps us in the early detection of safety trends and signals in large populations as the number , type, and length of exposure of patients to the product can vary greatly from those studied in the earlier phases of clinical trials.Project ManagementARI has the experience and local presence to promote your success, which we believe is dependent on well executed project management. Every ARI project manager is responsible for communicating with the client, ensuring accuracy, creating a management framework and employing risk management processes to address potential obstacles. ARI has built a reputation for excellence based on successful execution of these responsibilities. Trust ARI to manage the complete clinical trial process, including planning, patient and investigator recruitment, data management, biostatistics, clinical pharmacology, regulatory compliance, and much more. Clinical Monitoring ARI’s clinical monitoring team works with your company to ensure your product’s quality. Whether your clinical trial effort requires an assistant, an advisor, or a full partner, ARI has the tools to make your vision a reality. Our CRAs are some of the best in the industry and are located across the U.S. All our CRAs receive up to date interactive, computer-based GCP Training. They are trained in Adverse Event Reporting and regulatory affairs. Most of our CRAs has earned CCRA accreditation with many years of experience and are dedicated to building relationships with Investigators and Coordinators. We consider our Clinical Research Associate (CRA) to be an integral part of the study—that’s why ours have an average of 5 to 10 years of clinical research experience. Our regional CRA model allows us to provide hands-on coverage to all regions of the country and different regions of the world.Our monitors ensure quality investigators, oversee data collection, review documentation and forms, ensure regulatory compliance, resolve data queries and conduct analyses as they are requested. Our CRAs conduct on-site monitoring visits throughout the study to: • Oversee data collection • Review source documentation and case report forms • Ensure regulatory compliance • Resolve data queries • Conduct interim analyses as requested by clients Biostatistics Our sound approach to clinical biostatistics during the initial stages of your project will reduce risk, improve quality, save time and reduce costs. ARI biostatistics team offers more than just statistical analyses, they bring an understanding of the disease, the drug and assist in the study design development.Our statisticians will assist your company in protocol development and analysis for quality assurance. We review and analyze Phase II result, investigate data accuracy, and conduct power analyses. We support data and safety monitoring board (DSMBs) and conduct interim analyses. ARI statisticians benefit your company through their experience, flexibility, high standards for quality control, and expertise with tools such as nQuery, Advisor® and StatXact, Our services include:• Consultation on study and protocol design • Sample size calculations and Randomization services • Statistical analysis and plan development • Interim data analyses • Statistical reports • Preparation of electronic submission ready datasets Pharmacovigilance A vigilant and alert monitor and response to safety signals throughout a product’s lifecycle has a profound impact on the product success. By actively monitoring, collecting and analyzing information on your products as they move through the product life cycle, it is possible to avoid costly setbacks. Monitoring the product throughout its lifecycle fulfill the regulatory requirements for pharmacovigilance.ARI offers a full range of integrated pharmacovigilance and risk management services, customized to your needs:• Risk management planning• Case processing• Oversight group management• Post-marketing safety surveillance• Qualified/responsible person services• Safety publishing – aggregate reporting and SOPs• Quality assurance• Medical information • Biomedical literature surveillance • Safety training and education • Monitor safety and manage case reports• Mitigate risk earlier in development• Monitor, manage and maximize your product's risk-benefit profile • Improve the market value of your product with proactive planning and robust risk managementWhy choose ARI Pharmacovigilance Services? • Experienced, trained regulatory staff to steer through all regulatory requirements• Dedicated, experienced, trained medical and safety staff with an extensive range of therapeutic backgrounds • Experience in SAEs, in compliance with regulatory and local requirements • A collaborative environment, whether working with clients or third parties • Access to a range of state-of-the-art technical tools Regulatory AffairIt is essential to stay ahead of regulatory requirements while still ensuring the quality of products.It is of utmost importance to our staff that preparation for a regulatory submission must begin during the development stage of your product. We believe that a partnership with client ensures that regulatory processes an important part of the development plans. Additionally, we have a broad range of experiences in working with regulatory agencies. Our staff members are also trained to offer our clients recommendations in several areas, such as compliance, deficiencies, due diligence assessments, and risk reduction.Our services allow you to improve organization and efficiency, allowing you to respond to future compliance demands. Our staff’s primary goal is to guide a sponsor’s products through development so that it may be introduced to the market quickly. Our staff members have extensive training on regulatory agencies requirements, as well as training on preparing and submitting regulatory dossiers.

PHASE I
PHASE II AND III
POST APPROVAL

TECHNOLOGY

DATA MANAGMENT

ARI combine clinical and technological expertise to help our clients find the best way to conduct clinical research and to rapidly bring safe and effective new therapeutics and medical devices into the market place. "ARI's" Emonitor is the leading provider of advanced data management solutions for clinical trials and drug safety, offering proven solutions in electronic data capture (EDC), data management, and adverse event reporting (AER) as either an integrated solution or as stand-alone applications. We offer you the leading products in data capture, data management, and safety as an integrated solution. Emonitor is a comprehensive HIPAA, 21 CFR Part 11 compliant SAS®-based system for managing clinical trials including CRF tracking, data entry, and review. The simple interface allows you to set up your clinical studies in days. Emonitor leverage the power of the Internet for rapid data capture and processing, no special hardware or software installations required at the sites, reduces the overall trial cost significantly, reduces human error dramatically and saves time. Emonitor is platform independent, uses Microsoft Net web Technology, supports any popular database (Oracle/MS SQL and others), highly configurable, secured (SSL) with digital Signature support, fast and efficient. It allows instant viewing of data, automatic audit trail for every steps, real time edit check engine and instant feedback to users. Automatic query generation, manual DCF creation, easy query tracking and review by admin users. Automatic data locking for forms, individual answers and easy signing of data after review.Emonitor's advanced data management system is one stop shopping for your clinical trial need with integrated document processing, full support for international (double-byte) character sets concurrent usage in multiple languages provides capabilities for multi-national trials as well as a single database support for international operations. It provides user interface and work flow capabilities for both endpoint-driven protocols as well open ended surveillance studies and registries.

DATA INTEGRATION

Data Integration is necessary and efficacious for meeting the objectives of your clinical studies. In order to effectively manage clinical development, companies must constantly monitor regulatory compliance and have access to information into one comprehensive software application with data from a variety of systems, including trial management, pharmacokinetic/pharmacodynamic (PK/PD), electronic patient diaries, clinical patient data, central lab, pharmacovigilance data, IVRS, third party applications and databases (including CDMS and CTMS). Leveraging the clinical and technical integration expertise of Arroyo Research, clients can identify and implement clinical trial process improvements, extend their existing data to a wider user base, and share knowledge across multiple, disparate systems. Our integration services enable seamless and meaningful data integration between systems and expert data users enabling streamlined access, communication, decision-making, and overall trial performance.We have the knowledge of modern technology and system to help you to achieve your goal. Our staff understands the process of clinical development and requirement for regulatory affairs and thus can integrate and improve data system.We design our software applications to where the sponsors can have the most timely, accurate data collection, analysis, and reporting tools integrated at their fingertips.
CONTACT
9550 Warner Avenue, Suite # 232Fountain Valley, CA 92708Phone: 714-782-7105Fax: 877-484-5958Email: trials_arroyoresearch.com

ARROYO RESEARCH, INC.

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