Clinical Trial Design and Clinical Program Management
From administrative organization, to effective clinical trial implementation, oversight, and maintenance, Atlas Research facilitates and maximizes efficient clinical program management. Our team offers experience in all facets of trial design and program management.

Scientific and Technical Consulting
We offers our clients a strong track record in basic science and clinical data generation and management, laboratory work, clinical trials management, and experience with multiple FDA premarket approval submissions.

We have a knowledge base that includes various regulatory submissions; product stewardship and strategic planning; evaluation of clinical trial design; statistical analyses; formulation of successful national reimbursement strategies; primary research for biotechnology and pharmaceutical companies; and management of contract research organizations conducting clinical trials.

Protocols, Investigator Brochures, Trial Reports, Manuscripts
The Atlas Research team offers highly technical writing services for application submission, program protocols, case report forms, consent documents, clinical quality assurance and compliance, investigator brochure, regulatory affairs, medical education materials, journal manuscripts and abstracts, literature reviews, executive summary, and marketing brochures.

FDA Submissions and Regulatory Strategy Development
Atlas Research is skilled at navigating federal regulatory requirements, specifically those promulgated by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). Our experts have served as medical monitors and clinical program directors to randomized controlled trials. Our program operations include the management of two clinical research organizations, investigator sites across five states, the establishment of a data management system, study design and development of a statistical analysis plan, close coordination with institutional review boards and FDA offices, and regulatory submission of clinical trial study reports to the FDA.

Strategic Reimbursement Consulting
Atlas Research has provided strategic reimbursement consulting services to pharmaceutical, medical device, and biologics companies and to their investors, as well as to health care systems and health care leaders trying to improve operational efficiencies. Senior Atlas leaders serve on the CPT Editorial Panel Advisory Committee of the American Medical Association to help with coding issues for health care services and products. They have prepared economic analyses and outcomes research in support of reimbursement applications, as well as prepared marketplace analyses of coverage determinations and private payer clinical policies. Atlas staff have evaluated existing reimbursement strategies for health care products and conducted comparative cost analyses for investor due diligence assignments.