Full service CRO.
From discovery to approval.
Leading-edge scientific services in product discovery and development
CCS Associates, Inc. (CCSA) is a small business providing leading-edge scientific services in product discovery and development to government agencies and the pharmaceutical and biotech industries.
About CCS Associates
More than 40 Years of Client Success
CCS Associates, Inc (CCSA) is a small business providing leading-edge scientific advisory services in pharmaceutical and device discovery and development to government agencies as well as the pharmaceutical and biotech industries.
Our quality and risk management philosophy emphasizes open and frequent communication with all project team members so that requirements are clearly understood, changes are noted, challenges are addressed, and plans are executed to produce the best possible outcome.
Trusted By Leading Organizations
Our Services
Empowering Success Through Transparent Collaboration
We offer a comprehensive suite of services designed to guide you through every stage of product discovery and development. Our expertise spans strategic planning and regulatory affairs, ensuring that your project meets essential standards while navigating complex landscapes. We specialize in early development and clinical trials, leveraging cutting-edge bioinformatics to enhance data analysis and decision-making. With a robust approach to pharmacovigilance, we prioritize patient safety and compliance, complemented by our scientific and medical writing services that articulate your findings with clarity and precision. Additionally, our library services provide you with invaluable resources, and our eCTD services simplify regulatory submissions, empowering your journey from discovery to successful approval.
Strategic Planning
Regulatory Affairs
Early Development
Clinical Trials
Pharmacovigilance
Scientific and Medical Writing
eCTD
eCTD is the electronic transfer of information to regulatory agencies based on the Common Technical Document (CTD) format. eCTD utilizes PDF documents linked via an XML backbone.
Publications
Explore Our Comprehensive Publications
Our diverse collection of publications cover the nuances of clinical trials, reports, and studies, serving as a valuable resource for professionals seeking insights into a wide array of scientific research. Whether you are a researcher, clinician, or policy maker, our curated library offers a wealth of information designed to inform and inspire, empowering you to make informed decisions in your pursuit of scientific advancement.
Featured Publications
Clinical trial protocols
Ramasubramanian S. In: DeTora L, ed. Regulatory Writing: An Overview, 3rd ed. Rockville, MD: Regulatory Affairs Professionals Society, 2026, p. 69–74.
...First-in-human study of neuron regenerative therapy NNI-362 to evaluate the safety, pharmacokinetics, and pharmacodynamics in healthy aged population
Kelleher-Andersson J, Yoon E, Green C, McFarlane C, Bagheri D, Thomas LP, Turner RS. Alzheimers Res Ther 2025;17(1):185. PMID: 40775373.
...Comparing quantitative imaging biomarker alliance volumetric CT classifications with RECIST response categories
Zhao B, Obuchowski N, Yang H, Chou Y, Ma H, Guo P, Tang Y, Schwartz L, Sullivan D. Radiol Adv. 2025 Jan 6;2(1):umaf001. PMID: 39834611.
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