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Clinical Research

OUR APPROACH

When you conduct a trial you expect collaboration, commitment to rigor, and confidence in the data. You also expect your clinical research partner to always put your patients first. It requires well-coordinated, customer-centered, innovative thinking to drive a clinical trial to success. It’s what we do.

Your study outcomes are important, no matter what stage of research you are in. You need a team that understands your immediate goals and your short and long term objectives. You need an organization that can inform your design, guide you through challenges, and provide you with clear answers as you move forward. You need a strong partner with demonstrated expertise and flexibility. Because of our experience, our teams are built to adapt. This means being aware of and able to employ approaches or solutions as the terrain changes. It means applying the highest levels of scientific rigor from start up to closeout.

Industries We Serve

Life Sciences

Clinical Research services for Life Sciences.

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Government

Clinical Research services for Government.

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Collaborations

Clinical Research services for Collaborations.

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Clinical Research CAPABILITIES

Project Management

Helping deliver full service project management under the supervision of formally trained PMs who have hands-on experience running prospective and retrospective research studies. Our project managers are the primary point of contact for our clients, and our collaborative teams are built to the size, scope, and duration of each project to deliver study needs within the study requirements.

Recruitment and Retention

Collaborating to deliver strategic plans for recruitment and retention by creating a consistent, coherent message that adds value to each stakeholder group no matter where you are in your study. Our team identifies the best approach to manage relationships between participants and site coordinators, and between sites and researchers.

Data Management

Working with high-quality and well-organized data are prerequisites to rapid and reliable hypothesis testing. With an extensive background in large-scale and long-term studies, and management of claims data, we offer clients unparalleled data management services. Our data managers work collaboratively within the project teams, and have a keen understanding that the data they manage are more than just numbers.

PRO and Survey Instrument Development

Helping to deliver the consumer perspective through patient-reported outcomes (PROs) in evaluating treatment efficacy is a key strength. PROs are recognized as irreplaceable in many research areas because they provide data that cannot be captured in other ways. Our team has established expertise developing and delivering PRO study designs, survey development and testing, and data analysis.

Statistical Design and Analysis

Helping to deliver reliable, thoughtful study designs based on the highest standards of accuracy and scientific rigor for confident hypothesis testing on-time and within budget. Our statistical teams partner with scientific experts to design prospective studies and claims based data analyses. A multidisciplinary background helps to meet your study goals with a broader understanding of the populations and conditions important to your research.

Qualitative Research

Providing deeper insights for researchers and policy makers who recognize the potential of qualitative methods to enhance our understanding of health and healthcare. Qualitative methods—such as in-depth interviews and focus groups—complement quantitative approaches by capturing the complexities of “how and why” not easily understood through survey alone.

Site Based Registries

Making sure your study achieves scientific, commercial, and regulatory goals is our objective. Patient registries have evolved from basic lists of people with specific medical conditions into complex databases that carefully monitor disease states and track outcomes of medical interventions. Today’s patient registries are vital resources for capturing real-world patient information.

Large and Complex Database Analytics

Providing deep database expertise with medical claims, pharmacy claims, and laboratory results in collaboration with our data providers helps to ensure the validity and quality of the raw data. Scientific expertise integrating and harmonizing diverse data types and sources gives us an unparalleled understanding of the nuances of the data assets we manage.

Post-Market Surveillance

Helping to meet FDA-required post-market surveillance studies and registries using a variety of providers to help minimize risk and ensure patient safety. We go beyond working with research sites by building on relationships in the community. This access, combined with database expertise, allows us to systematically identify risks, monitor performance, and help deliver product benefits.

Medical Device

Developing regulatory strategies for medical devices to help obtain timely and cost-effective regulatory medical device clearances and approvals in compliance with domestic and international regulatory requirements. Our team of experts understand how to prepare a lifecycle regulatory strategy, as well as manage and prepare submissions to help achieve timeline approvals.

Regulatory Affairs

Delivering a solid regulatory strategy must be built into projects from the beginning. Our rigorous scientific approach helps to identify solutions for clients, tailoring strategies for their investigational products. Our innovative approach often exceeds the requirements of regulatory authorities during clinical and post-market phases. Through years of working closely with these agencies, we have developed a reputation for thoroughness and attention to detail.

Consensus Conferences

Establishing best practices in diagnostic and treatment approaches are often difficult to achieve, with little consensus among experts. Through our broad expertise and strong relationships with key opinion leaders, we have the expertise and relationships to convene consensus conferences on the state of the science to improve dissemination of best practices and identify gaps in the field. Our team has a systematic process for coordinating consensus conferences with national and global leaders to create the space for these important conversations.

Special Populations Research

Bringing proven experience to clinical trials and registries for groups with orphan conditions can make all the difference. We deliver deep relationships with clinical sites, patient advocacy groups, and non-profit organizations to help meet trial goals and timelines. Our expertise begins with neonates, but spans the life course through adult and aging populations with chronic conditions.

Quality Assurance

Delivering quality assurance (QA) requires a solid scientific foundation. Through strong scientific principles we provide QA expertise, led by our experienced QA team and combined with a collaborative team approach. Our QA procedures involve controls at every level from management to individual processes. Our standard operating procedures have been developed in discussion with each core service group, while being led and managed by our QA experts.

Site Management and Monitoring

Delivering appropriate site selection is key to recruitment, regulatory acceptance, cost, and meeting study timelines. Site management is particularly important in hard to reach populations with rare conditions. We have established an extensive global database of sites and investigators with proven track records for excellent patient recruitment and protocol adherence to help your study achieve success.

Pharmacovigilance, Medical Device Safety, and Safety Management

Product safety is paramount in all stages of the development lifecycle. In addition to traditional pharmacovigilance and medical device safety reporting, we provide comprehensive support for Data & Safety Monitoring Board (DSMB) and Clinical Event/Endpoint Committee (CEC) selection and management during the clinical trial. Our experienced team has current knowledge on safety regulations and clinical safety data, access and experience with the requisite data systems, and established relationships with the regulatory and provider stakeholders to conduct an efficient, balanced and thorough process. Our pharmacovigilance department compliments our Safety & Epidemiology work with the FDA Sentinel Programs.

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